Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vinflunine · 5 trials · 12 indications
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria. Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks. Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters. The final response criteria assigned represented the best response obtained during treatment.
Defined as the percentage of patients with an objective decrease in PSA and/or experience an objective benefit from treatment.
PFS survival is defined as the time between randomization and the date of progression or death, whichever occurs first, before or after treatment discontinuation. For those still on study and those who remain alive and have not progressed after treatment discontinuation, PFS will be censored on the date of the last tumor assessment.
| Arm | Type | Description |
|---|---|---|
| Intervention | EXPERIMENTAL | Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion. |
| Interventional | EXPERIMENTAL | - |
| vinflunine and gemcitabine | EXPERIMENTAL | solution for injection, IV, vinflunine: 280/320 mg/m2 + gemcitabine: 1000 mg/m2, every 3 wks, variable duration |
| placebo and gemcitabine | PLACEBO_COMPARATOR | solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration |
| HER2 Negative Intervention | EXPERIMENTAL | Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes, repeated every 21 days |
| HER2 Positive Intervention | EXPERIMENTAL | Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2. |
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Vinflunine | DRUG | 320mg/m2 every 21 days as a 15-20 minute infusion |
| Gemcitabine | DRUG | solution for injection, IV, placebo + gemcitabine, 1000 mg/m2, every 3 wks, variable duration |
| Placebo | OTHER | - |
| Trastuzumab | DRUG | Anti-HER2 monoclonal antibody |
Inclusion Criteria: * Small cell lung cancer with progression after one previous chemotherapy or chemotherapy/radiation therapy regimen * Measurable or evaluable disease * Able to perform activities of daily living with minimal assistance * Adequate hematological, liver, and kidney function * Must ...
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Vinflunine is an investigational small molecule being studied for the treatment of several cancers, including breast cancer, bladder cancer, prostate cancer, small cell carcinoma, and transitional cell carcinoma. It is in Phase 2 clinical development and has not been approved by the FDA.
Vinflunine is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various oncology indications.
Vinflunine is in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. All completed trials for Vinflunine are Phase 2 studies, and there are no active trials currently ongoing.
Vinflunine has been studied in several Phase 2 clinical trials, including NCT00101608 for transitional cell carcinoma of the urothelium, NCT00284154 for relapsed extensive small cell lung cancer, NCT00284180 for HER2-overexpressing metastatic breast cancer, and NCT00389155 for advanced bladder cancer.
Vinflunine is a small molecule that works by targeting microtubules, which are essential for cell division. By interfering with microtubule dynamics, it disrupts cancer cell proliferation. This mechanism is typical of vinca alkaloid class drugs used in oncology.