Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Zactima (ZD6474), Zactima (vandetanib), Vandetanib, ZD6474
Zactima · 35 trials · 35 indications
The PFS was defined as the time (in months) from randomization until the date of first documented disease progression or death (from any cause), whichever came first. Disease progression as per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) was defined as: at least a 20% increase and absolute increase of 5 mm in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Analysis was performed by Kaplan-Meier method.
The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.
Median time (in weeks) from randomization 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 Response Evaluation Criteria in Solid Tumors (RECIST) assessment.
Median time (in weeks) from randomization 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.
Median time to progression (months) from randomisation until objective disease progression (determined by RECIST assessments) or death (by any cause in the absence of objective progression) provided death is within 3 months from the last evaluable RECIST assessment. Values here are estimated (from a Weibull model) as the medians were not met.
Overall Survival (OS) is defined as the time from date of randomization until death. Any blinded/unknown patient which have died at the time of analysis will be censored based on the last recorded date on which the patient was known to be alive (ie, their status must be known at the censored date and should not be lost to follow up or unknown).
Progression was defined as Time from the date of first dose of study medication to progression of disease, or death (it also includes patients who are lost to follow-up or have withdrawn consent) and evaluated with RECIST criteria as an increase of at least 20% in the sum of longest diameter (LD) of target lesion(s) taking as reference the smallest sum of LD since the treatment started or any new lesion(s).
Progression-free survival (PFS) rate at 3 months is defined as the number of patients without evidence of progression or death after 3 months from randomisation among the PFS-evaluable patients.
To assess the effect of vandetanib on biological progression free rate based on PSA level (assessable set). PSA progression free rate defined as the number of participants with : * After decline from baseline: a 25% increase above the nadir * No decline from baseline: a 25% increase above the baseline (min. increase of 2 ng/mL)
modified RECIST V1.0 was used.
Tumour stabilisation rate calculated as percentage of patients with best objective tumour response (Complete Response, Partial Response or Stable Disease) for \>=16 weeks based on Response Evaluation Criteria in Solid Tumours (RECIST). Complete Response - Disappearance of all target lesions; Partial Response - \>=30% decrease in the sum of longest diameter of target lesions; Progressive Disease - \>=20% increase in the sum of longest diameter of target lesions; Stable Disease - neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) as defined by RECIST criteria. The categories for best objective response are CR, PR, stable disease (SD)\>= 12 weeks, progressive disease (PD) or NE.
Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
Prostate Specific Antigen (PSA) response was defined as a reduction of at least 50% from baseline at any assessment, confirmed by a second assessment 2-4 weeks after the initial response
The ORR is the number of patients that are responders ie those patients with a confirmed best objective response of complete response (CR) or partial response (PR) defined according to RECIST 1.0.
ORR is defined as the percentage of patients who have a confirmed CR (Disappearance of all target lesions) or PR (\>=30% decrease in the sum of diameters of target lesions) prior to any evidence of progression as defined by RECIST V1.1. This percentage is calculated with only patients who had at least measurable lesion in the efficacy analysis set.
| Arm | Type | Description |
|---|---|---|
| Vandetanib/ Vandetanib | EXPERIMENTAL | Participants received Vandetanib 300 mg tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months). Participants who completed the randomized treatment period, were offered the opportunity to continue the same vandetanib treatment in the open label period, if in the investigator's opinion, they received benefit and if the participant agreed and provided their informed consent to continue the open-label period for up to additional 31 months. |
| Placebo/ Vandetanib | PLACEBO_COMPARATOR | Participants received placebo matched to Vandetanib tablet, orally once daily until disease progression or death, in randomized treatment period (up to maximum of 40 months). Participants who completed the randomized treatment period, and experienced disease progression were offered the option of treatment in open-label period with vandetanib, if in the investigator's opinion, they received benefit and if the participant agreed and provided their informed consent to begin open-label vandetanib treatment i.e., 300 mg tablet, orally once daily for up to 31 months. |
| Vandetanib Control | ACTIVE_COMPARATOR | Control - treatment 300mg vandetanib opel label |
| Experimental | EXPERIMENTAL | Experimental - treatment 300mg vandetanib opel label |
| 1 | PLACEBO_COMPARATOR | Placebo Vandetanib + Pemetrexed |
| 2 | EXPERIMENTAL | Vandetanib + Pemetrexed |
| A | EXPERIMENTAL | Vandetanib 300 mg as a once daily oral dose, from Day 1 |
| B | EXPERIMENTAL | Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to plus Vandetanib 100 mg orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy) |
| C | PLACEBO_COMPARATOR | Gemcitabine administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles plus Vandetanib 100 mg Matching Placebo orally once-daily, from Day 1 (after 6 cycles, in the absence of disease progression or unacceptable toxicity, Investigators remain at liberty to continue Gemcitabine plus Vandetanib / Placebo or to continue Vandetanib / Placebo monotherapy). |
| Vandetanib | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| vandetanib (ZD6474) | EXPERIMENTAL | vandetanib (ZD6474) 300 mg per os once daily |
| 3 | EXPERIMENTAL | Best Supportive Care + ZD6474 300 mg |
| ZD6474 100mg | EXPERIMENTAL | Daily dose |
| ZD6474 200mg | EXPERIMENTAL | daily dose |
| ZD6474 300mg | EXPERIMENTAL | daily dose |
| Caprelsa (vandetanib) 300 mg | EXPERIMENTAL | Daily oral dose of Caprelsa (vandetanib) 300mg |
| Vandetanib 300mg | EXPERIMENTAL | 300 mg/day vandetanib |
| vandetanib then vandetanib + omeprazole | EXPERIMENTAL | Vandetanib alone in period 1 followed by vandetanib in combination with omeprazole in period 2 |
| vandetanib + omeprazole then vandetanib | EXPERIMENTAL | Vandetanib in combination with omeprazole in period 1 followed by vandetanib alone in period 2 |
| vandetanib then vandetanib + ranitidine | EXPERIMENTAL | Vandetanib alone in period 1 followed by vandetanib in combination with ranitidine in period 2 |
| vandetanib + ranitidine then vandetanib | EXPERIMENTAL | Vandetanib in combination with ranitidine in period 1 followed by vandetanib alone in period 2 |
| 100 mg Vandetanib eod | EXPERIMENTAL | 100 mg Vandetanib every other day dosing |
| 100 mg Vandetanib od | EXPERIMENTAL | 100 mg Vandetanib once daily dosing |
| 300 mg Vandetanib od | EXPERIMENTAL | 300 mg Vandetanib once daily dosing |
| ZD6474 (vandetanib) 100mg | EXPERIMENTAL | - |
| ZD6474 (vandetanib) 300mg | EXPERIMENTAL | - |
| Dose level 1 | ACTIVE_COMPARATOR | Vandetanib 100mg/day plus Gemcitabine |
| Dose level 2 | ACTIVE_COMPARATOR | Vandetanib 300mg/day plus Gemcitabine |
| Dose level 3 | ACTIVE_COMPARATOR | Vandetanib 100mg/day plus Gemcitabine plus CapecitabineDose |
| Dose level 4 | ACTIVE_COMPARATOR | Vandetanib 300mg/day plus Gemcitabine plus CapectiabineDose |
| Name | Type | Description |
|---|---|---|
| Vandetanib (SAR390530) | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Placebo | DRUG | Pharmaceutical form: tablet Route of administration: oral |
| Patient outreach | BEHAVIORAL | Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner |
| Vandetanib | DRUG | Treatment 300mg vandetanib opel label. |
| Pemetrexed | DRUG | intravenous infusion |
| ZD6474 (Vandetanib) | DRUG | once daily oral tablet |
| Best Supportive Care | OTHER | standard of care |
| Erlotinib | DRUG | oral dose |
| ZD6474, Vandetanib | DRUG | 300 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| Gemcitabine | DRUG | administered intravenously at 1000 mg/m2 over 30 minutes on Days 1 and 8 of each 21-day cycle up to 6 cycles or until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| Placebo matching ZD6474 | DRUG | Placebo to match ZD6474 100 mg as a once daily oral dose, from Day 1 until disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| Placebo to Match ZD6474, Vandetanib | DRUG | 100 mg as a once daily oral dose, from Day 1 UNTIL disease progression or unacceptable toxicity or consent withdrawal whichever occurs first |
| Bicalutamide | DRUG | 150mg orally, once daily |
| FOLFIRI | DRUG | Intravenous infusion |
| FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid | DRUG | intravenous infusion |
| Vandetanib (ZD6474) | DRUG | once daily oral dose |
| Docetaxel | DRUG | intravenous infusion |
| Zactima (vandetanib) | DRUG | - |
| Prednisolone | DRUG | - |
| ZD6474 (vandetanib) 100mg | DRUG | once daily oral dose |
| ZD6474 (vandetanib) 200mg | DRUG | once daily oral dose |
| ZD6474 (vandetanib) 300mg | DRUG | once daily oral dose |
| ZD6474 | DRUG | - |
| Paclitaxel | DRUG | - |
| Carboplatin | DRUG | - |
| ZD1839 | DRUG | - |
| adjuvant therapy | PROCEDURE | - |
| VEGF-receptor tyrosine kinase (KDR) | DRUG | - |
| Vandetanib 300mg | DRUG | 300 mg oral dose once daily (100 mg x 3 tablets) |
| omeprazole | DRUG | Oral capsules, 40 mg, multiple doses |
| ranitidine | DRUG | Oral tables, 150 mg, multiple doses |
| Cisplatin | DRUG | intravenous infusion |
| Radiation | RADIATION | radiation of head and neck |
| Vandetanib 300 mg | DRUG | 300mg once daily |
| Zactima (ZD6474) | DRUG | - |
| Vinorelbine plus cisplatin | DRUG | - |
| Gemcitabine plus cisplatin | DRUG | - |
| ZD6474 (Zactima) 100mg | DRUG | - |
| Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MR) | PROCEDURE | - |
| Biomarker Draws | PROCEDURE | - |
| ZD6474 (Zactima) 300mg | DRUG | - |
| 5-Fluorouracil | DRUG | intravenous infusion |
| Leucovorin | DRUG | intravenous infusion |
| Oxaliplatin | DRUG | intravenous infusion |
| Irinotecan | DRUG | intravenous infusion |
Inclusion Criteria: * Provision of informed consent to participate in the study as well as provision of informed consent to provide a sample of a previously obtained archival tumor biopsy. * Female or male aged 18 years and older with previously confirmed histological diagnosis of locally advanced ...
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Zactima is an investigational small molecule oncology drug being developed by Sanofi (ticker SNY). It has been studied in non small cell lung cancer and prostate cancer, including metastatic hormone refractory prostate cancer. Zactima is not described as approved and remains in clinical development.
Zactima has been studied in non small cell lung cancer as part of a Phase 1 combination regimen with vinorelbine or gemcitabine plus cisplatin in patients with locally advanced or metastatic disease. This research is investigational and does not establish that Zactima is approved for treating non small cell lung cancer.
Zactima is developed by Sanofi, which trades under the ticker SNY. Sanofi is the company associated with the clinical development of Zactima in oncology, including studies in non small cell lung cancer and prostate cancer.
Zactima is in Phase 1 development. Its clinical program includes a completed Phase 1 study in non small cell lung cancer and a completed Phase 2 study in metastatic hormone refractory prostate cancer. Zactima is investigational and is not described as FDA approved.
Zactima has been evaluated in completed trials including NCT00496275, a Phase 1 combination study with vinorelbine or gemcitabine plus cisplatin in locally advanced or metastatic non small cell lung cancer, and NCT00498797, a Phase 2 study in metastatic hormone refractory prostate cancer conducted in Brazil, Germany, Hungary, South Africa, and Sweden.
Yes. Zactima is also known as ZD6474 and vandetanib, so searches for any of these names refer to the same drug. It is an investigational small molecule developed by Sanofi (ticker SNY) and studied in non small cell lung cancer and prostate cancer.