Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Docetaxel is a microtubule inhibitor indicated for: Breast Cancer (BC) : single agent for locally advanced or metastatic BC after chemotherapy failure; and with doxorubicin and cyclophosphamide as adjuvant treatment of operable node-positive BC ( 1.1 ) Non-small Cell Lung Cancer (NSCLC) : single agent for locally advanced or metastatic NSCLC after platinum therapy failure;
Also known as Docetaxel, TAXOTERE®
XRP6976 · 57 trials · 29 indications
A participant was considered to have had a DFS event if there was evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.
Overall and radiographic progression-free survival in patients with metastatic hormone-naïve prostate cancer treated by androgen deprivation therapy and docetaxel
PFS was defined as the time from randomization to objective tumor progression, or recurrence or death. Progressive disease (PD) was defined as follows: 1) In Neoadjuvant Chemotherapy +Surgery +Adjuvant Chemotherapy (CSC) Arm, PD was determined according to the RECIST 1.1 Criteria during the neo-adjuvant chemotherapy period; 2) Irrespective of curative resection, if an intraoperative distant metastasis was observed or a distant metastasis was reported from pathology, it was considered PD; 3) If residual cancer cells were visually identified at the resection margin during surgery but could not be completely resected (R2), it was considered PD; 4) If residual cancer cells were finally confirmed at the resection margin during postoperative histology (R1), it was considered PD; 5) In case of finding a recurrence/distant metastasis or a new lesion during follow-up after R0 complete resection, it was defined as the first tumor assessment date when it was observed.
The primary objective of this study is to determine whether adding early chemotherapy based on docetaxel plus prednisone compared to standard of care alone reduces disease progression as evidenced by detectable PSA in high risk patients with prostate cancer who have undergone radical prostatectomy.
Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
Median time (in weeks) from randomisation until objective disease progression or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Progression was derived according to RECIST 1.0 and is defined as an increase of at least 20% in the total tumour size of measurable lesions over the nadir measurement, unequivocal progression in the non-target lesions or the appearance of one or more new lesions.
Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up
The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Disease Free Survival was defined as the interval from the date of randomization to the date of local, regional or metastatic relapse or the date of second primary cancer (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) or death from any cause whichever occured first. Disease free survival was estimated using the Kaplan-Meier method.
DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death.
Disease-Free Survival (DFS)- are defined as local, regional or metastatic relapse or the date of second primary cancer or death from any cause whichever occurs first.
PSA response was defined as ≥50% decrease in PSA levels in both treatment arms from baseline, during the whole treatment, before treatment switch and after treatment switch. PSA progression was defined as decline of PSA from baseline (an increase of ≥25% \[at least 2ng/ml\] over the nadir value, confirmed by a second PSA value at least 3 weeks apart) and no decline of PSA from baseline (an increase of ≥25% \[at least 2ng/ml\] over the baseline value after 12 weeks of treatment, confirmed by a second PSA value at least 3 weeks apart). Because the purpose of this study is to explore the benefit of a regimen in which participants are switched to a different taxane if PSA does not decrease ≥30% after 4 cycles, irrespective of which agent (docetaxel or cabazitaxel) is administered initially, the data for participants who began treatment with docetaxel and for those who began treatment with cabazitaxel were combined for the efficacy analyses.
Analysis of CTCs is a co-primary endpoint. Growth of prostate cancer cells is dependent on sustained androgen receptor (AR) nuclear signaling. Taxanes (e.g., docetaxel and cabazitaxel) may mediate some of their activity in prostate cancer by impairing AR trafficking along the microtubules from the tumor cell cytoplasm into the nucleus, as a result of taxane-induced microtubule bundling (MTB). Blood samples were collected at baseline and post-treatment to allow isolation of CTCs, which were evaluated for tumor cell biomarker measures %ARNL and MTB score. %ARNL was assessed by quantitative analysis of images of CTCs captured by geometrically enhanced differential immunocapture (GEDI). Reduction from baseline in %ARNL (percentage of total cellular AR that is located in the nucleus) may indicate inhibition of AR signaling. Change from baseline in %ARNL at Cycle 1 Day 8 is summarized by categories of participants with PSA decrease from baseline (≥50%, Not ≥50%) after Cycle 4.
Analysis of CTCs is a co-primary endpoint. Growth of prostate cancer cells is dependent on sustained AR nuclear signaling. Taxanes (e.g., docetaxel and cabazitaxel) may mediate some of their activity in prostate cancer by impairing AR trafficking along the microtubules from the tumor cell cytoplasm into the nucleus, as a result of taxane-induced MTB. Blood samples were collected at baseline and post-treatment to allow isolation of CTCs, which were evaluated for tumor cell biomarker measures %ARNL and MTB score. MTB in images of CTCs captured by GEDI was qualitatively assessed by three independent operators for increase compared with baseline on a scale of 0 to 3 from no to most MTB increase. Increase from baseline in MTB may indicate inhibition of AR signaling. Change from baseline in MTB at Cycle 1 Day 8 is summarized by categories of participants with PSA decrease from baseline (≥30%, Not ≥30%) after Cycle 4.
The primary objective of this proof-of-concept study is to determine the objective response rate in patients with unresectable, stage IIIB and IV non-small cell lung carcinoma treated with the combination cisplatin, docetaxel and bevacizumab. This response rate will be compared to historical data from the ECOG4599 and AVAiL trials.
The length of time, in months, that patients were alive from the end of their treatment without any signs or symptoms of their disease.
CR assessed by independent reviewers, according to the Modified Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI). Disease response evaluated after the completion of the induction treatment and prior to the radiation treatment. CR defined as the complete disappearance of the target and non-target lesion(s) identified at baseline after radiological evaluation by Magnetic Resonance Imaging (MRI) only.
The percentage of participants with Grade 3/4 clinical CHF was calculated. Grade 3/4 CHF symptoms included cardiac failure congestive, cardiomyopathy, and left ventricular dysfunction (LVEF). Echocardiography (ECG) or multiple-gated acquisition (MUGA) scans were scheduled after Cycles 3 and 6 of chemotherapy, after every 3rd cycle of trastuzumab alone, at end of therapy and every 6 months at follow-up to measure changes in LVEF. Clinical symptoms e.g., shortness of breath, tachycardia, cough, neck vein distention, cardiomegaly, hepatomegaly were further investigated for CHF.
Pathologic Complete Response (pCR) rate, assessed as no evidence of invasive disease in excised surgical specimens of breast and/or axilla, in participants who received at least 1 cycle of docetaxel and lapatinib and at least one follow-up evaluation.
PFS was the time from registration to first documentation of * progressive disease (PD) based on Response Evaluation Criteria in Solid Tumors (RECIST) - criteria pre-defining changes in lesion size or appearance * symptomatic deterioration * death due to any cause (in absence of PD). The Percentage of participants with PFS is reported. For the analysis, participants were censored * on the last available tumor assessment date on study treatment if they * had no PFS event * were on anticancer therapy not related to study treatment * on the registration date if they * did not receive study drug * had no post baseline tumor assessment
Time to PFS was the interval from the date of registration to the earliest of the following documented dates: * PD as defined by RECIST (criteria pre-defining changes in lesion size or appearance) * symptomatic deterioration * death. Time to PFS was estimated from Kaplan-Meier Plots.
Participants were evaluated for clinical CHF every 3 weeks during chemotherapy, every 3 months while on maintenance therapy, and every 3 months during the 2-year follow-up period. Left ventricular ejection fraction (LVEF) of CHF was assessed by multi-gated acquisition (MUGA) or echocardiogram (ECHO) performed midway through completion of chemotherapy according to a treatment-specific schedule, every 12 weeks during maintenance therapy, and at 6 and 24 months after completion of maintenance therapy. Grade 3-4 CHF were identified through a clinical review of all study collected investigator verbatim and the Medical Dictionary for Regulatory Activities (MedDRA). The preferred terms (PT) cardiac failure congestive, cardiomyopathy, and ejection fraction decreased were associated with CHF.
PFS was defined as the interval from the date of registration to the earliest date of documented evidence of progressive disease, or the date of death due to any cause, whichever occurred first. Progressive disease occurred when the participant had at least a 20% increase in the sum of the longest diameter (LD) of target lesions, compared to the smallest sum LD recorded since the treatment started, or the appearance of 1 or more new lesions.
A response was defined as a decrease in tumor size of \>50% for the largest lesion in the prostate by endorectal MRI.
Tumor assessments were performed by Computed tomography (CT) and Magnetic Resonance Imaging (MRI) to evaluate disease progression based on Gynecologic Oncology Group (GOG) Response Evaluation Criteria in Solid Tumors (RECIST). Disease progression was recorded as any one of the following: * appearance of a new lesion * symptomatic deterioration * progression of target or nontarget lesions * death Participants who did not die or show show disease progression achieved PFS. PFS rate is the percent of participants who achieved PFS.
| Arm | Type | Description |
|---|---|---|
| Arm A: EC-T | ACTIVE_COMPARATOR | Epirubicin with cyclophosphamide, followed by docetaxel (EC-T): Epirubicin 90 mg/ m2 in combination with cyclophosphamide 600 mg/m2 (EC) every 21 days for 4 cycles, followed by docetaxel 100 mg/m2 (T) every 21 days for 4 cycles. |
| Arm B: ET-X | EXPERIMENTAL | Epirubicin and docetaxel followed by capecitabine (ET-X):Epirubicin 90 mg/m2 and docetaxel 75 mg/ m2 (ET) every 21 days for 4 cycles, followed by capecitabine 1,250 mg/m2 bid for 14 days, followed by a 7-day rest for 4 cycles. |
| Arm A | ACTIVE_COMPARATOR | androgen deprivation therapy + docetaxel |
| Arm B | EXPERIMENTAL | androgen deprivation therapy + docetaxel + abiraterone acetate + prednisone |
| Arm C | EXPERIMENTAL | Arm A + radiotherapy |
| Arm D | EXPERIMENTAL | Arm B + radiotherapy |
| Surgery + Adjuvant Chemotherapy (SC) | OTHER | Participants underwent surgery within 2 weeks after randomization followed by adjuvant chemotherapy with S-1 \[(Gimeracil) + Oxo (Oteracil)\] 40 milligrams per square meter (mg/m\^2) administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after End-of-Treatment (EOT) until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 10 years). |
| Neoadjuvant Chemotherapy +Surgery +Adjuvant chemotherapy (CSC) | EXPERIMENTAL | Participants received neo-adjuvant chemotherapy with Docetaxel 50 mg/m\^2 intravenously (IV) for greater than or equal to (\>=)1 hour (hr) on Day 1 of each treatment cycle plus Oxaliplatin 100 mg/m\^2 IV for \>=2 hr on Day 1 of each treatment cycle plus S-1 \[(Gimeracil) + Oxo (Oteracil)\] 40 mg/m\^2 administered orally twice daily from Day 1 to 14, of each treatment cycle followed by surgery approximately 1-3 weeks after completion of neo-adjuvant chemotherapy and adjuvant chemotherapy with S-1 \[(Gimeracil) + Oxo (Oteracil)\] 40 mg/m\^2 administered orally twice daily, from Day 1 to 28 of each cycle for 1 year, and were followed-up after EOT until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 10 years). |
| First line treatment: docetaxel 75 mg/m² + cisplatin 75 mg/m² | EXPERIMENTAL | Docetaxel 75 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles |
| First line treatment:: docetaxel 60 mg/m² + cisplatin 75 mg/m² | EXPERIMENTAL | Docetaxel 60 mg/m² + cisplatin 75 mg/m² on day 1, repeated every 3 weeks, up to 4 cycles |
| Maintenance treatment: docetaxel (60 mg/m2) | EXPERIMENTAL | Docetaxel 60 mg/m² on day 1, repeated every 3 weeks until progressive disease or up to 6 cycles |
| Maintenance treatment: best supportive care (BSC) | ACTIVE_COMPARATOR | BSC until progressive disease |
| Docetaxel Cisplatin 5-Fluorouracil (DCF) | EXPERIMENTAL | 4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Docetaxel 60mg/m² on day 1 * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5 |
| Cisplatin 5-Fluorouracil (CF) | EXPERIMENTAL | 4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment): * Cisplatin 75mg/m² on day 1 * 5-FU 750mg/m²/day on day 1 to day 5 |
| 1 | EXPERIMENTAL | docetaxel chemotherapy + modafinil 100 mg capsules |
| 2 | PLACEBO_COMPARATOR | docetaxel chemotherapy + placebo (lactose) capsules (matched to modafinil drug) |
| Arm 1: Docetaxel and Prednisone | ACTIVE_COMPARATOR | Chemotherapy after radical prostatectomy |
| Arm 2: Standard of care | NO_INTERVENTION | Standard of care |
| Arm1: Androgen Suppression Therapy + Radiation Therapy | OTHER | Androgen Suppression Therapy and Radiation therapy |
| Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy | EXPERIMENTAL | Docetaxel plus androgen suppression therapy and radiation therapy |
| TPF | EXPERIMENTAL | Docetaxel, Cisplatine, 5-FU |
| PF | ACTIVE_COMPARATOR | Cisplatine, 5-FU |
| Doxorubicin+Cyclophosphamide (AC) followed by Docetaxel (AC→T) | EXPERIMENTAL | Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles. |
| AC followed by Docetaxel + Herceptin (AC→TH) | EXPERIMENTAL | Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose. |
| Docetaxel + Carboplatin + Herceptin (TCH) | EXPERIMENTAL | Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose. |
| Arm A: FAC | ACTIVE_COMPARATOR | FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv |
| Arm B: TAC | EXPERIMENTAL | TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv |
| TAC (Docetaxel) | EXPERIMENTAL | docetaxel (75 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment |
| FAC (5-fluorouracil) | ACTIVE_COMPARATOR | 5-fluorouracil (500 mg/m\^2) in combination with doxorubicin (50 mg/m\^2) and cyclophosphamide (500 mg/m\^2) on day 1 every 3 weeks for 6 cycles of treatment |
| Docetaxel + Prednisone (Treatment A) | EXPERIMENTAL | Docetaxel 75 mg/m\^2 intravenous (IV) infusion on Day 1 of Cycle 1 and every 3 weeks (q3w) thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with \<30% PSA reduction from baseline at the end of Cycle 4 switched to Cabazitaxel 25mg/m\^2 IV infusion on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), death, unacceptable toxicity or participant's refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant's refusal of further study treatment. |
| Cabazitaxel + Prednisone (Treatment B) | EXPERIMENTAL | Cabazitaxel 25 mg/m\^2 IV infusion on Day 1 of Cycle 1 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily. Participants with \<30% PSA reduction from baseline at the end of Cycle 4 switched to Docetaxel 75mg/m\^2 IV infusion on Day 1 of Cycle 5 and q3w thereafter, in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, death, unacceptable toxicity or participant's refusal of further study treatment. Participants with ≥30% PSA reduction from baseline at the end of Cycle 4, continued on the same treatment which they received before switching until DP, death, unacceptable toxicity or participant's refusal of further study treatment. |
| IMRT & docetaxel-cisplatin | EXPERIMENTAL | Concurrent chemo-RT: Radiotherapy: IMRT - Docetaxel 20mg/m2 + cisplatin 20mg/m2 weekly for 6 weeks - Resting period: 2 weeks - Adjuvant chemotherapy: Q3W for 2 cycles Docetaxel 35 mg/m² IV infusion for 1 hour on D1\&8 - Cisplatin 35 mg/m² on D1\&8 - Dexamethasone for a total of 3 doses is to be given at a dose of 4 mg at 12 hours, 1 hour before and 12 hours after docetaxel administration |
| Docetaxel/Carboplatin/Bevacizumab/Erlotinib | EXPERIMENTAL | - |
| Docetaxel and Carboplatin | ACTIVE_COMPARATOR | - |
| Docetaxel/Cisplatin/5-FU (TCF) | EXPERIMENTAL | * Docetaxel 75 milligrams per square meter (mg/m²) over 1 hour on Day 1 every 3 weeks * Cisplatin 75 mg/m² Day 1 over 6 hours every 3 weeks * 5-Fluorouracil 750 mg/m²/day continuous infusion Days 1 to 4 every 3 weeks as an induction therapy Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
| Cisplatin/5-FU (CF) | ACTIVE_COMPARATOR | * Cisplatin 80 mg/m² Day 1 over 6 hours every 3 weeks * 5-Fluorouracil 1000 mg/m²/day continuous infusion Day 1 to 4 every 3 weeks as an induction therapy. Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks. |
| Stratum 1: TAC + Bevacizumab | EXPERIMENTAL | Human epidermal growth factor receptor-2 (HER2) negative participants stratified at registration, were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks. All participants were administered prophylactic recombinant Granulocyte Colony Stimulating Factor (G-CSF) during chemotherapy, based on a dose recommended by the manufacturer. For participants with estrogen receptor (ER) or progesterone receptor (PR) positive tumors, anti-estrogen therapy was recommended. Participants could receive radiation therapy at the discretion of the treating medical and radiation oncologist. |
| Stratum 2: TCH + Bevacizumab | EXPERIMENTAL | HER2 positive participants stratified at registration, were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks. All participants were administered prophylactic recombinant Granulocyte Colony Stimulating Factor (G-CSF) during chemotherapy, based on a dose recommended by the manufacturer. For participants with estrogen receptor (ER) or progesterone receptor (PR) positive tumors, anti-estrogen therapy was recommended. Participants could receive radiation therapy at the discretion of the treating medical and radiation oncologist. |
| Neoadjuvant Chemotherapy | EXPERIMENTAL | Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year. |
| TE (Taxotere and Eloxatin) | EXPERIMENTAL | Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin). Each chemotherapy cycle was repeated every 21 days. Participants received either the optimal or non-optimal dose for Taxotere and Eloxatin. Participants who received the optimal dose for Taxotere and Eloxatin were analyzed in this study. |
| TEF (Taxotere, Eloxatin and 5-FU) | EXPERIMENTAL | Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and 5-FU (5-Fluorouracil). Each chemotherapy cycle was repeated every 14 days. Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and 5-FU. Participants who received the optimal dose for Taxotere, Eloxatin and 5-FU were analyzed in this study. |
| TEX (Taxotere, Eloxatin and Xeloda) | EXPERIMENTAL | Docetaxel (Taxotere) in combination with Oxaliplatin (Eloxatin) and capecitabine (Xeloda). Each chemotherapy cycle was repeated every 21 days. Participants received either the optimal or non-optimal dose for Taxotere, Eloxatin and Xeloda. Participants who received the optimal dose for Taxotere, Eloxatin and Xeloda were analyzed in this study. |
| Docetaxel and Bevacizumab | EXPERIMENTAL | Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
| Docetaxel, Bevacizumab and Trastuzumab | EXPERIMENTAL | Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met |
| Stratum 1 (AC->T + bevacizumab) | EXPERIMENTAL | HER2-negative participants administered * doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by * docetaxel (T) + bevacizumab for 4 cycles followed by * bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed |
| Stratum 2 (TAC + bevacizumab) | EXPERIMENTAL | HER2-negative participants administered * docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by * bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed |
| Stratum 3 (TCH + bevacizumab) | EXPERIMENTAL | All HER2-positive participants administered * docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by * bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed |
| Docetaxel/Oxaliplatin/Bevacizumab | EXPERIMENTAL | Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of docetaxel, followed by oxaliplatin, and then bevacizumab for Cycles 1-6 (every 3 weeks), and followed with maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks. |
| chemotherapy | EXPERIMENTAL | docetaxel and bevacizumab prior to prostatectomy |
| Docetaxel/Cisplatin/Fluorouracil (DCF) | EXPERIMENTAL | DCF combination for three 21-day cycles unless a disease progression is observed at the tumor assessment scheduled after the second cycle or due to patient intolerability |
| Oxaliplatin/Docetaxel/Bevacizumab | EXPERIMENTAL | Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery |
| A | EXPERIMENTAL | - |
| B | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | Cisplatin + Radiotherapy |
| docetaxel and cisplatin | ACTIVE_COMPARATOR | - |
| docetaxel | EXPERIMENTAL | - |
| Taxotere/Irinotecan | EXPERIMENTAL | - |
| docetaxel plus cisplatin | EXPERIMENTAL | Taxotere 75 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by cisplatin 75 mg/m² administered as a 30-minute to 3-hour infusion on Day 1 |
| cisplatin plus 5-FU | ACTIVE_COMPARATOR | Cisplatin 100 mg/m², 30-minute to 3-hour infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 1000 mg/m²/day from Day 1 to Day 5 |
| docetaxel plus 5-FU | EXPERIMENTAL | Taxotere 85 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 750 mg/m²/day from Day 1 to Day 5 Arm only in the phase II part of the study |
| Name | Type | Description |
|---|---|---|
| Docetaxel | DRUG | - |
| Capecitabine | DRUG | - |
| Epirubicin | DRUG | - |
| Cyclophosphamide | DRUG | - |
| abiraterone acetate | DRUG | abiraterone 1000mg/day (4 tablets of 250 mg (PO) per day) + prednisone 5mg bid |
| radiotherapy | RADIATION | 74 Gy in 37 fractions 3D-Conformal RT or Intensity Modulated RT (IMRT) |
| Androgen Deprivation Therapy | OTHER | The ADT must consist in either LHRH agonist, LHRH antagonist or orchiectomy |
| Docetaxel (XRP6976) | DRUG | Pharmaceutical form:solution for infusion Route of administration: intravenous |
| Oxaliplatin (SR96669) | DRUG | Pharmaceutical form:solution for infusion Route of administration: intravenous |
| S-1 (1-(2-tetrahydrofuryl)-5-fluorouracil + 5-chloro-2, 4-dihydroxypyridine (CDHP) (Gimeracil) + Oxo (Oteracil) | DRUG | Pharmaceutical form:Tablet Route of administration: Oral |
| Cisplatin | DRUG | Formulation: concentrated solution for intravenous infusion (IV) Route(s) of administration: 1-3-hour IV |
| Best supportive care (BSC) | OTHER | Any treatment including palliative radiotherapy for pain relief-but not chemotherapy - that is considered appropriate by the investigator |
| 5-FLUOROURACIL | DRUG | Intravenous |
| DOCETAXEL(XRP6976) + MODAFINIL | DRUG | arm 1: best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily arm 2: best supportive care (docetaxel chemotherapy) plus placebo of modafinil 200mg mane daily |
| Modafinil | DRUG | best supportive care (docetaxel chemotherapy) plus modafinil 200mg mane daily |
| Placebo of Modafinil | DRUG | Best supportive care (docetaxel chemotherapy) + placebo capsules one daily-mane (before noon) |
| Mitoxantrone | DRUG | 12mg/m² intravenously every 21 days |
| Prednisone | DRUG | 10mg orally given daily |
| Vandetanib | DRUG | oral |
| Androgen Hormonal Suppression and Radiation | DRUG | Total Androgen Ablation and external beam radiation therapy |
| Androgen Suppression Therapy and Radiation Therapy | DRUG | Total Androgen Ablation and External Beam Radiation Therapy |
| 5-Fluoro-3-Pyridinecarboxylic Acid | DRUG | 750 mg/m 2 by 24-hour continuous infusion for 5 days |
| docetaxel, doxorubicin, cyclophosphamide | DRUG | TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel. |
| Docetaxel,doxorubicin, cyclophosphamide | DRUG | AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles. |
| Docetaxel/DDP | DRUG | - |
| docetaxel/gemcitabine | DRUG | - |
| Doxorubicin | DRUG | - |
| Herceptin | DRUG | - |
| Carboplatin | DRUG | - |
| XRP6976 (Docetaxel/Taxotere) | DRUG | - |
| Cetuximab | DRUG | dosage : 5mg/ml one administration per week: 400 mg/m2 then 250 mg/m2 during 18 weeks |
| calcitriol | DIETARY_SUPPLEMENT | - |
| CABAZITAXEL (XRP6258) | DRUG | Pharmaceutical form: Concentrate and solvent for solution for infusion Route of administration: Intravenous |
| Intensity Modulated Radiotherapy (IMRT) | RADIATION | 2 Gy per fraction |
| Bevacizumab | DRUG | 3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -\> Staging -\> further 3 cycles BCD Q3W -\> Bevacizumab Q3W until progression |
| S-1 | DRUG | 80mg/m² day 1-14 every 3 weeks for 3 cycles. The curative resection group will receive two oral doses of 40 mg/m²/day for 4 weeks, followed by 2 weeks rest, for 1 year. |
| OXALIPLATIN | DRUG | 100 mg/m² on day 1 as a two-hour IV infusion for each period of 3 weeks for 3 cycles. |
| Docetaxel/Carboplatin/Bevacizumab/Erlotinib | DRUG | Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1 Docetaxel should be administered before carboplatin. After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows: Maintenance Treatment for patients in Cohort A: Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity. |
| Docetaxel/Carboplatin | DRUG | Adjuvant Treatment Cohort B: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Docetaxel should be administered before carboplatin. Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment. |
| Trastuzumab | DRUG | A single loading dose of 8 mg/kg administered IV on Day 2 for Cycle 1, and 6 mg/kg administered IV on Day 1 for Cycles 2-6 and for maintenance therapy |
| Lapatinib | DRUG | 1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles) |
| Pegfilgrastim | DRUG | 6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments. |
| Filgrastim | DRUG | 300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies. |
| Dexamethasone | DRUG | 8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel |
| Docetaxel + Oxaliplatin | DRUG | Dose level 1 (non-optimal dose): Docetaxel 75 mg/m² as an 1-hour intravenous (IV) infusion on day 1 followed by Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1 Dose level 2 (optimal dose): Docetaxel 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin 130 mg/m² as a two to six-hour IV infusion on day 1 |
| Docetaxel + Oxaliplatin + 5-FU | DRUG | Dose level 1 (non-optimal dose): Docetaxel 40 mg/m² as a 1-hour intravenous (IV) infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m2 as a 46-hour continuous infusion day 1. Dose level 2 (optimal dose): Docetaxel 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1. |
| Docetaxel + Oxaliplatin + Capecitabine | DRUG | Dose level 1 (optimal dose): Docetaxel 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m2 two times a day continuously. Dose level 2 (non-optimal dose): Docetaxel 65 mg/m² as a 1-hour IV infusion on day 1, Oxaliplatin 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine 625 mg/m² two times a day continuously. |
| Doxorubicin and cyclophosphamide (AC) + bevacizumab | DRUG | For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * doxorubicin 60 mg/m\^2 IV push or infusion followed by cyclophosphamide 600 mg/m\^2 IV push or infusion * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy |
| Docetaxel (T) + bevacizumab | DRUG | For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * docetaxel 100 mg/m\^2 IV * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy Note: The starting dose of docetaxel was reduced to 75 mg/m\^2 if toxicity occurred that met the criteria for doxorubicin dose reduction |
| Docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab | DRUG | For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * doxorubicin 50 mg/m\^2 IV push or infusion followed by cyclophosphamide 500 mg/m\^2 IV push or infusion followed by docetaxel 75 mg/m\^2 * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy |
| Docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab | DRUG | For every 3-week cycle * bevacizumab 15 mg/kg infused intravenously (IV) on Day 1 followed by * docetaxel in 75 mg/m\^2 IV followed by carboplatin AUC 6 mg/mL/min IV followed by * trastuzumab 6 mg/kg by IV infusion (For the first cycle 1 only a loading dose of trastuzumab 8 mg/kg IV was infused on Day 2) * Prophylactic G-CSF was administered within 24 hours following each cycle of chemotherapy but no greater than 72 hours after chemotherapy |
| Bevacizumab and trastuzumab maintenance therapy | DRUG | * bevacizumab 15 mg/kg was infused IV followed by * trastuzumab 6 mg/kg IV Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed. |
| Bevacizumab maintenance therapy | DRUG | \- bevacizumab 15 mg/kg was infused IV Treatment was every 3 weeks for 52 weeks from the date of the first administration regardless of the number of doses received or missed. |
| Fluorouracil | DRUG | Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 750 mg/m2/day for 5 days |
| Bevacizumab (Avastin®) | DRUG | 15 mg/kg bevacizumab administered intravenously (IV) over 30 to 90 minutes on Day 1 of every 3 week cycle for 12 months or until disease progression or unacceptable toxicity |
| Docetaxel (Taxotere®) | DRUG | 75 mg/m\^2 docetaxel was administered IV over 1 hour on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity |
| Oxaliplatin (Eloxatin®) | DRUG | 85 mg/m\^2 Oxaliplatin was administered IV over 2 hours on Day 1 of every 3 week cycle for 6 cycles or until disease progression or unacceptable toxicity |
| Docetaxel and cisplatin followed by gemcitabine | DRUG | docetaxel 75 mg/m2 day 1 + cisplatin 75 mg/m2 day1 repeated every 21 days for 3 cycles followed by gemcitabine 1200 mg/m2 day 1,8 repeated every 21 days for 3 cycles |
| docetaxel and cisplatin followed by concurrent chemoradiotherapy with docetaxel and cisplatin + radiotherapy | DRUG | docetaxel (75mg/m2, IV, Day 1) and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles, followed by concurrent chemoradiotherapy with docetaxel (20 mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy |
| docetaxel and cisplatin + radiotherapy followed by docetaxel and cisplatin | DRUG | docetaxel (20mg/m2, IV) and cisplatin (20 mg/m2) weekly for 6 weeks + radiotherapy 2 Gy/day, 5 days per week to a total dose of 66 Gy followed by docetaxel and cisplatin (40 mg/m2, IV, Day 1, 2) every 3 weeks for 2 cycles. |
| docetaxel and carboplatin | DRUG | weekly docetaxel 30mg/m2 and four weekly carboplatin AUC (Area under curve) 5 |
| docetaxel and cisplatin | DRUG | 4 cycles Cisplatin 100 mg/m2 at every 3 weeks, after Cisplatin 4 cycles of docetaxel 100mg/m2 at every 3 weeks |
| Docetaxel, cisplatin and 5-FU treatment followed by concomitant cisplatin, 5-FU and radiotherapy | DRUG | - |
| Concomitant cisplatin, 5-FU and radiotherapy | DRUG | - |
| Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy | DRUG | Docetaxel 75 mg/m2, Day 1 of the cycle + Cisplatin 75 mg/m2 Day 1 + 5-FU 750 mg/m2/day in 24-h continuous infusion for 5 days. 3 cycles will be administered, every 21 days, before the local-regional treatment (same as control group) |
| Cisplatin, 5-fluorouracil (5-FU), radiotherapy | DRUG | Cisplatin 100 mg/m2 Day 1, 5-FU 1000 mg/m2/day in 24-h continuous infusion for 5 consecutive days. 3 cycles will be administered every 21 days, before the local-regional treatment (same as control group) |
| Cisplatin + radiotherapy | OTHER | Cisplatin 100 mg/m2 on days 1, 22 and 43 simultaneously with radiotherapy (2 Gy x 1/day, 5 days per week for 7 weeks-tumor- and 2 Gy x 1/day, 5 days per week for 6 weeks- lymph nodes) |
| Docetaxel and Gemcitabine | DRUG | Docetaxel: 40 mg/m², administered IV over 60 minutes (infusion drop by drop during the first five minutes) on day 1 and 8 immediately followed by Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8 |
| Gemcitabine cisplatin followed by docetaxel | DRUG | Gemcitabine: 1200 mg/m2, administered IV over 30 minutes on day 1 and 8 followed by Cisplatin 75 mg/m2, administered IV over 30-60 minutes on day 2 |
| DOCETAXEL(XRP6976) | DRUG | docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle |
| Docetaxel + carboplatin + radiotherapy + docetaxel + gemcitabine | DRUG | Docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy. Further on, 2 Docetaxel cycles and gemcitabine according to arm 2. |
| Docetaxel + gemcitabine + carboplatin + radiotherapy | OTHER | Docetaxel 40 mg/ m² days 1, 8, 21 and 28 with gemcitabine 1200 mg/ m² days 1, 8, 21 and 28 followed by concomitant treatment with docetaxel 20 mg/m²/week with carboplatin AUC 2/week and concomitant radiotherapy up to 60 Gy (2 Gy/day, 5 days per week and for 6 weeks). |
| Docetaxel + CDDP | DRUG | * 3 cycles chemotherapy : docetaxel + CDDP * Surgery (if no histologically proven R0-resection could be achieved,additional adjuvant radiotherapy should be considered) * 3 cycles adjuvant chemotherapy docetaxel |
| Irinotecan | DRUG | 50mg/m2 IV each week for 4 weeks |
| XRP6976 | DRUG | - |
| 5-fluorouracil (5-FU) | DRUG | - |
Inclusion Criteria: * Written informed consent. * Histological diagnosis of operable invasive adenocarcinoma of the breast (T1-T3). Tumours must be HER2 negative. Time window between surgery and study randomization must be less than 60 days. * Surgery must consist of mastectomy or conservative surg...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
XRP6976 is an investigational oncology therapy developed by Sanofi, known also as XRP6976 (Docetaxel/Taxotere). It is a small molecule studied in cancer, including stomach neoplasm and head and neck cancer. It has been evaluated in clinical trials but is not described as approved.
XRP6976 has been studied for the treatment of cancer, including stomach neoplasm (gastric cancer) and locally advanced head and neck cancer. Trials have evaluated it in combination regimens for these tumor types. It remains an investigational agent rather than an established approved treatment.
XRP6976 is developed by Sanofi, which trades under the ticker SNY. Sanofi sponsored the clinical trials evaluating the agent in gastric cancer and head and neck cancer.
XRP6976 has been evaluated in Phase 3 clinical development. One completed Phase 3 trial studied it in locally advanced head and neck cancer, and a completed Phase 2 trial studied it in advanced gastric cancer. It is investigational and not described as approved.
XRP6976 has been studied in completed trials including NCT00290966, a randomized multicenter study of docetaxel plus cisplatin and 5-FU versus cisplatin plus 5-FU in advanced gastric cancer, and NCT00273546, a Phase 3 induction chemotherapy study in locally advanced head and neck cancer.
XRP6976 is also known as XRP6976 (Docetaxel/Taxotere), indicating it is associated with docetaxel, marketed as Taxotere. The trial titles reference docetaxel and Taxotere, so searches for those names relate to the same agent.