Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Gemcitabine
LY2334737 · 73 trials · 47 indications
Length of time, in months, that patients were alive from their first date of protocol treatment until death.
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
TTPD is defined as the time from the day of treatment to first observation of documented disease progression or death due to any cause, whichever comes first. TTPD was censored at the time of last follow-up for patients who were still alive without progression. Tumor response was assessed in cancer patients by using Response Evaluation Criteria in Solid Tumors (RECIST), which define when cancer patients improve ("respond"), stay the same ("stabilize"), or worsen ("progression") during treatments. Progressive Disease is a ≥20% increase in sum of longest diameter of target lesions.
Progression free survival was defined as the duration from the date of randomization to the first date of documented disease progression or death from any cause. Tumor assessments were performed every three 21-day cycles during induction and crossover. Progression free survival was censored at the date of the last follow-up visit for participants who were still alive and who had not progressed. Results are presented as a comparison between the two study treatment sequences (induction therapy followed by elective consolidation or crossover therapy) rather than the two induction therapies.
Original outcome was Progression-Free Survival (PFS) probability at 3 years. PFS=time from baseline to progressive disease (PD) or death from any cause. Probability is not an accepted "Measure Type", so number of progression-free patients still at risk and cumulative number of patients that had an event (PD or death of any cause) are presented.
Time to disease progression (TTDP) at initial treatment was defined as the number of months between date of randomization and the date of first documented disease progression or the date of death due to disease under study, whichever came first. TTDP censored at earliest of: 1) date of death not due to disease; or 2) date of last contact for participants alive without disease progression; or 3) start date of other anti-tumor therapy; or 4) first dose date of crossover treatment.
Progression-free survival is calculated as the time from randomization to the first observation of disease progression or date of death (whichever occurs earlier). Progression-free survival time will be censored at the time of the most recent information for patients who are still alive at the time of the last visit.
Time-to-Progression (TTP) was assessed as the time from start of treatment to progression, as observed on radiographic scans and assessed per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria for progressive disease (ie, a 5-mm absolute increase of the sum of the longest diameters of the target lesions in addition to a 20% increase in the sum of the target lesions)
3-year disease free survival rates:The progression is defined consistent with contrast enhanced MRI/CT.
ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated \* 100.
PFS was measured from date of first dose to first date of progressive disease (PD) or death from any cause. For each participant who was not known to have died or to have had PD as of the data inclusion cut-off date for a particular analysis, PFS duration was censored for that analysis at the date of the participant's last progression-free tumor assessment before that cut-off date.
Percentage of patients alive at 1 year.
Median progression-free survival (PFS) was assessed as the time to disease progression; toxicity requiring treatment discontinuation; or death.
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment. Responders are patients with complete response or partial response.
Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. ORR was defined as the proportion of participants who achieved a best response of either CR or PR. ORR=number of participants with CR or PR/number of participants qualified for tumor response analysis (per-protocol population).
Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection. Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Proportion of patients with metastatic breast cancer free of disease progression at 6 months following treatment
Response recorded at the first follow-up visit using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Percentage of participants alive at 2 years.
Complete pathological response: No invasive tumor cells identified from sections from site of previous cancer. Require evidence corroborating prior presence of invasive cancer, which requires detection of abnormal fibroelastic breast stroma devoid of normal lobular units and contains foamy macrophages with moderate numbers of fibroblasts and mononuclear inflammatory cells. Presence of nondescript collagenised lobules or breast fibrous tissue is not evidence that tumor site has been adequately sampled and macroscopic assessment and sampling is needed until original neoplastic stroma identified.
Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.
For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD). The MTD was the highest dose level at which \<2 out of 6 participants experienced a dose-limiting toxicity (DLT) in Cycle 1. DLT was an adverse event (AE) during Cycle 1 that was likely related to LY2334737 and fulfilled any of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE) ≥Grade 3 nonhematological (except nausea/vomiting controlled with treatment); Grade 3 neutropenia with fever or any Grade 4 neutropenia with or without fever; Grade 3 thrombocytopenia with ≥Grade 2 bleeding or Grade 4 thrombocytopenia with or without bleeding; A recovery period longer than 14 days from last dose of LY2334737 to values allowing Cycle 2 to start; Other significant drug-related toxicity deemed by investigator to be dose limiting or that caused the participant to withdraw from the study. Pharmacokinetics and pharmacodynamics (PK/PD) were also taken into consideration for Phase 2 recommended dose.
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| Regimen A | EXPERIMENTAL | Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1 Carboplatin area under the curve (AUC) 6.0 IV, day 1 Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10 Regimen A was repeated at a 21-day interval |
| Regimen B | EXPERIMENTAL | Irinotecan 100 mg/m2 IV, days 1 and 8 Gemcitabine 1000 mg/m2 IV, days 1 and 8 Regimen B was repeated at a 21-day interval |
| A: Docetaxel and Gemcitabine (Tri-weekly) | EXPERIMENTAL | Docetaxel and Gemcitabine (Tri-weekly) |
| B: Paclitaxel and Gemcitabine (Tri-weekly) | EXPERIMENTAL | Paclitaxel and Gemcitabine (Tri-weekly) |
| C: Docetaxel and Gemcitabine (Weekly) | EXPERIMENTAL | Docetaxel and Gemcitabine (Weekly) |
| D: Paclitaxel and Gemcitabine (Weekly) | EXPERIMENTAL | Paclitaxel and Gemcitabine (Weekly) |
| Gemcitabine/Carboplatin | EXPERIMENTAL | Gemcitabine 1000 milligrams per meter square (mg/m\^2) Day 1 and Day 8, Carboplatin Area Under the Curve (AUC) 5 Day 1, six 21-day cycles |
| Paclitaxel/Carboplatin | ACTIVE_COMPARATOR | Paclitaxel 175 milligrams per meter square (mg/m\^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21 day cycles |
| 1 | EXPERIMENTAL | Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Gemcitabine 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks Brachytherapy, 30-35 Gy over 1 week Two week rest period with no chemotherapy or radiation Cisplatin, 50 mg/m2, intravenous (IV), day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles |
| 2 | ACTIVE_COMPARATOR | Cisplatin, 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks and Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks Brachytherapy, 30-35 Gy over 1 week |
| Gemcitabine + Docetaxel | EXPERIMENTAL | - |
| Capecitabine + Docetaxel | ACTIVE_COMPARATOR | - |
| Arm A: Vinorelbine | ACTIVE_COMPARATOR | Arm A: Vinorelbine 30 mg/m2 will be administered as an intravenous infusion over 6-10 minutes on Study Days 1 and 8. |
| Arm B: Vinorelbine and Gemcitabine | EXPERIMENTAL | Arm B: Vinorelbine 30 mg/m2 will be administered as an intravenous infusion over 6-10 minutes on Study Days 1 and 8. Gemcitabine will be administered following vinorelbine at a dose of 1200 mg/m2 as an intravenous infusion over 30 minutes. |
| A | OTHER | - |
| B | EXPERIMENTAL | - |
| Treatment Period | EXPERIMENTAL | Treatment will be administered once every 2 weeks. One cycle of therapy will consist of 14 days. Paclitaxel is administered first after appropriate premedications. Gemcitabine is administered second and Avastin is administered after chemotherapy, all given on day 1 of each cycle. |
| Phase II 3-drug regimen | EXPERIMENTAL | Gemcitabine + Paclitaxel + Bevacizumab |
| Afatinib with GEMOX | EXPERIMENTAL | Patients will receive targeted therapy(Afatinib 40mg orally from day 1 to day 21 combined with GEMOX chemotherapy(gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion) |
| GEMOX | ACTIVE_COMPARATOR | Patients will receive conventional GEMOX chemotherapy (gemcitabine 1000 mg/m2 on days 1 and 8 of each cycle by IV infusion and oxaliplatin 100 mg/m2 on day 1 of each cycle by IV infusion） |
| GCiC + IMC-A12 (Gemcitabine/Cisplatin/Cetuximab + Cixutumumab) | EXPERIMENTAL | Cycles repeat every 3 weeks for first 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met \*Cisplatin will replace Carboplatin. Gemcitabine/Carboplatin/Cetuximab (GCC) plus cixutumumab will change to Gemcitabine/Cisplatin/Cetuximab (GCiC) plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab) |
| GCiC (Gemcitabine/Cisplatin/Cetuximab) | ACTIVE_COMPARATOR | Cycles repeat every 3 weeks for 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met \*Cisplatin will replace Carboplatin. GCC plus cixutumumab will change to GCiC plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab) |
| Gemcitabine + Bevacizumab | EXPERIMENTAL | Gemcitabine 2500 milligrams per square meter (mg/m\^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity. Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity. |
| Gemcitabine + Cisplatin | EXPERIMENTAL | Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. |
| Gemcitabine | EXPERIMENTAL | Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal. |
| Bevacizumab + carboplatin + gemcitabine | EXPERIMENTAL | Bevacizumab in combination with carboplatin and gemcitabine: •Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles. Carboplatin was administered before the gemcitabine infusion: •Gemcitabine, administered 1000 mg/m² IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles Bevacizumab was administered 1 hour after end of all chemotherapy infusions: •Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity |
| paclitaxel plus bevacizumab (PB) | ACTIVE_COMPARATOR | paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days |
| paclitaxel plus bevacizumab plus gemcitabine (PB+G) | EXPERIMENTAL | paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days |
| Single Group Assignment | EXPERIMENTAL | Cisplatin + Gemcitabine + Bevacizumab |
| Intervention | EXPERIMENTAL | Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy. |
| Gemcitabine + Paclitaxel | EXPERIMENTAL | gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles. |
| Gemcitabine + Carboplatin | EXPERIMENTAL | gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles. carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles. |
| Arm 1 Gemcitabine/Cisplatin/Trastuzumab | EXPERIMENTAL | Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Cisplatin 30 mg/m2 iv over 90 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). |
| Arm 2 Gemcitabine / Trastuzumab | ACTIVE_COMPARATOR | Gemcitabine 1000 mg/m2 iv over 30 minutes on days 1 and 8 Trastuzumab 2 mg/kg iv over 30 minutes on days 1, 8 and 15 (if trastuzumab was not administered within the past 3 weeks, a loading dose of 4 mg/kg iv over 90 minutes will be given on the first day of cycle 1 only). |
| HER2+ | EXPERIMENTAL | Human Epidermal growth factor Receptor 2 positive (HER2+): Gemcitabine + Carboplatin + Herceptin. |
| HER2- (Taxane-) | EXPERIMENTAL | Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-naive patients). |
| HER2- (Taxane+) | EXPERIMENTAL | Human Epidermal growth factor Receptor 2 negative (HER2-): Gemcitabine + Carboplatin. (Taxane-pretreated patients). |
| A+FFG | EXPERIMENTAL | Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid |
| A+FOLFOX 4 | ACTIVE_COMPARATOR | Avastin + Oxaliplatin + 5-Fluorouracil (5FU)/Folinic Acid |
| Gemcitabine plus Docetaxel | EXPERIMENTAL | - |
| Gemcitabine+Doxorubicin+Cisplatin+Surgery | EXPERIMENTAL | Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8). Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision. |
| Gemcitabine/folinic acid/5-FU | EXPERIMENTAL | Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m² |
| LY2334737 - Arm A | EXPERIMENTAL | LY2334737 administered orally at escalating doses \[40 milligrams (mg) - 200 mg\] every other day for 21 days followed by 7 days without study drug (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met. |
| LY2334737 - Arm B | EXPERIMENTAL | LY2334737 administered orally at escalating doses (40 mg - 200 mg) every day for 7 days followed by 7 days without study drug then repeated (28 day treatment cycle). Participants may receive additional treatment cycles until discontinuation criterion is met. |
| Single Arm | EXPERIMENTAL | Gemcitabine will be given at 1250 mg per meter squared over 2 hours days 1 and 8 of a 21 day cycle for a total of 4 cycles. Radiation: External Radiation Therapy The total dose would be 19.2 Gy divided over 32 fractions twice a day, on day 1 and day 8 after chemotherapy. |
| Name | Type | Description |
|---|---|---|
| Etoposide | DRUG | 50 mg alternating with 100 mg PO, days 1 and 10 in regimen A |
| Gemcitabine | DRUG | 1000 mg/m2 IV, days 1 and 8, in regimen B |
| Irinotecan | DRUG | 1000 mg/m2 IV days 1 and 8 in regimen B |
| Paclitaxel | DRUG | 200 mg/m2 by 1-hour IV infusion, day 1, regimen A |
| Carboplatin | DRUG | Area under the curve (AUC) 6.0 IV, day 1, regimen A |
| Docetaxel | DRUG | Arm A: 75 milligram per square meter (mg/m²), 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. Arm C: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15, to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD. |
| Vinorelbine | DRUG | - |
| capecitabine | DRUG | - |
| liposomal doxorubicin | DRUG | - |
| Cisplatin | DRUG | - |
| Brachytherapy | RADIATION | Brachytherapy, 30-35 Gy over 1 week |
| Pelvic radiation | RADIATION | Pelvic radiation, 1.8 Gy/day, 5 days/week, 6 weeks |
| surgery | PROCEDURE | surgery |
| gemcitabine hydrochloride | DRUG | - |
| Avastin | DRUG | 10mg/kg will be given via IV over 90 mins (1st dose). Patients must remain under supervision for 1 hr after completion of the initial dose of Avastin. If no side effects occur, shortened, 60-min 2nd infusion, the post-infusion observation period for the subsequent infusions may be shortened to 20 minutes, and eliminated entirely with the fourth and subsequent infusions. |
| Bevacizumab | DRUG | Bevacizumab 10 mg/kg by IV infusion, days 1 and 15 in 28-day cycles |
| Trastuzumab | DRUG | Trastuzumab |
| 5-FU | DRUG | 5-FU 750 mg/m2 (24h CI) |
| Folinic Acid | DRUG | Folinic Acid 200 mg/m2 (30 min) |
| Gemcitabine, Etoposide | DRUG | Pancreatic cancer is a devastating disease. Previous research shows a correlation between a specific oncogene change (ras-mutation) and enhanced sensitivity to two chemotherapy drugs combined: gemcitabine and etoposide. This Phase II trial will evaluate this drug combination for locally advanced and metastatic pancreatic cancer |
| gemcitabine and oxaliplatin. | DRUG | GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin. |
| Afatinib | DRUG | Target therapy Drug: afatinib |
| IMC-A12 (cixutumumab) | BIOLOGICAL | 6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle) \[First 6 cycles (18 weeks)\] |
| Cetuximab | BIOLOGICAL | 400 mg/m\^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m\^2 once per week thereafter \[First 6 cycles (18 weeks)\] |
| Epirubicin | DRUG | Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles |
| Albumin-bound Paclitaxel | DRUG | ABI-007 175 mg/m2 D1 q 14 days x 6 cycles |
| radiation | RADIATION | 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5 |
| Herceptin | DRUG | Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion). |
| gemcitabine, capecitabine | DRUG | - |
| mitomycin C | DRUG | - |
| radical cystectomy | PROCEDURE | - |
| radiotherapy | PROCEDURE | - |
| LY293111 | DRUG | - |
| radical surgery | PROCEDURE | - |
| chemoradiotherapy | PROCEDURE | - |
| 5FU/folinic acid | DRUG | Folinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG). Folinic Acid: 200 mg/m2 as a 2-hr infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4). 5-Fluorouracil: 450 mg/m2 as an IV bolus in middle of Folinic Acid (A+FFG). 5-Fluorouracil: 400 mg/m2 bolus plus a 600 mg/m2 22-hour infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4). |
| oxaliplatin | DRUG | 85 mg/m2 as a 2-hour infusion on Day 1 of a 14 day cycle. |
| dexamethasone | DRUG | - |
| Celecoxib | DRUG | - |
| radiation therapy | RADIATION | In conjunction with induction chemotherapy, radiation therapy is administered at a dose of 200 centi Gray (cGy) per day, Monday through Friday for 6 weeks |
| doxorubicin | DRUG | 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4) |
| placebo | DRUG | - |
| LY900003 | DRUG | - |
| gemcitabine, folinic acid, 5-FU | DRUG | gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours |
| Prednisone | DRUG | - |
| Vinblastine | DRUG | - |
| Doxorubicin (Adriamycin) | DRUG | - |
| LY2334737 | DRUG | Administered orally |
Inclusion Criteria: To be included in this study, you must meet the following criteria: * Carcinoma of unknown primary site * Biopsy-proven metastatic carcinoma * Able to perform activities of daily living with minimal assistance * No previous treatment with any systemic therapy * Measurable or ev...
LY2334737 is an investigational small molecule being studied for the treatment of malignant solid tumors, including solid tumors that are advanced and/or have spread (metastatic). It is being developed by Eli Lilly and Company for use in oncology.
LY2334737 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is an investigational small molecule intended for the treatment of malignant solid tumors.
LY2334737 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is no longer in active clinical trials.
LY2334737 has been studied in one clinical trial, NCT01648764, titled 'A Study of LY2334737 in Participants With Cancer That is Advanced and/or Has Spread.' This Phase 1 trial was completed and enrolled 73 participants with malignant solid tumors, including metastatic tumors.
LY2334737 is the only name provided for this investigational drug. No alternative names have been reported for this compound, which is being developed by Eli Lilly and Company for the treatment of malignant solid tumors.