Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication Gemcitabine Injection is a nucleoside metabolic inhibitor indicated: • in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy. FDA label
Gemcitabine · 8 trials · 7 indications
Progression free survival was defined as the time interval from the date of randomization to the date of first disease progression (as assessed by Independent Radiologic Review (IRR) based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria), or the date of death due to any cause, whichever occurred first. In the absence disease progression or death, the participant was censored at the date of the last valid tumor assessment performed before the cut-off date.
Clinical benefit rate was defined as the percentage of patients with complete response, partial response or stable disease ≥6 months.
| Arm | Type | Description |
|---|---|---|
| gemcitabine/carboplatin | ACTIVE_COMPARATOR | - |
| gemcitabine/carboplatin plus Iniparib | EXPERIMENTAL | - |
| Arm G/C | ACTIVE_COMPARATOR | gemcitabine/carboplatin on Days 1 and 8 of 21-day cycle(s) |
| Arm G/C/I | EXPERIMENTAL | gemcitabine/carboplatin on Days 1 and 8, plus iniparib on Days 1, 4, 8, and 11 of 21-day cycle(s) |
| Stratum 1 | ACTIVE_COMPARATOR | Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease). Randomization schedules will be produced for each stratum, and treatment allocation will be carried out centrally |
| Stratum 2 | ACTIVE_COMPARATOR | Subjects will be randomized in a 1:1 allocation to either GEMOX or CP after signed consents and baseline evaluations are completed, allowing for safe entry into the study. In order to avoid an unbalanced distribution by baseline characteristics, randomization will be stratified by one factor: disease stage (in a 1:4 proportion for Stage IIIb vs. Stage IV or relapsed disease). |
| 1 | EXPERIMENTAL | standard chemotherapy plus BSI-201 |
| Name | Type | Description |
|---|---|---|
| gemcitabine/carboplatin | DRUG | i.v. |
| gemcitabine/carboplatin plus Iniparib | DRUG | i.v. |
| Iniparib | DRUG | Body weight adjusted dose intravenous infusion (60 ± 10 minutes) |
| gemcitabine/Eloxatin (GEMOX) | DRUG | GEMOX \[gemcitabine/Eloxatin™ (Oxaliplatin) - 21 day cycle\] Gemcitabine 1000 mg/m2 will be administered over 30 minutes on Days 1 and 8 and Eloxatin™ 130 mg/m2 will be administered over 2 hours on Day 1, after gemcitabine administration, every 21 days \[3-week cycle\] |
| carboplatin/paclitaxel (CP) | DRUG | CP \[carboplatin/paclitaxel - 21 day cycle\] o Paclitaxel 225 mg/m2 will be administered over 3 hours on Day 1 followed by carboplatin at a dose calculated to produce an area under the concentration-time curve (AUC) of 6.0 over 30-60 minutes on Day 1 every 21 days \[3-week cycle\] |
| gemcitabine plus carboplatin plus BSI-201 | DRUG | iv, 3 week cycles |
| Gemcitabine, Docetaxel, 5FU, Oxaliplatin | DRUG | Gemcitabine: 1000 mg/m2 IV bolus days 1 and 8, repeated every 21 days x 8cycles Docetaxel: 40 mg/m2 IV bolus days 1 and 8, repeated every 21 days x 8 cycles Gemcitabine/docetaxel will be repeated (based upon initial response) Oxaliplatin: 40 mg/m2 IV on day 1 of each week of radiation 5-FU: 175 mg/m2 continuous infusion on days 1-18 and 29-46 of radiation |
| Alpha-interferon | BIOLOGICAL | Alpha-interferon: injected subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 29, 31, 33, 36, 38, 40, 43 and 46 during radiation therapy |
| Abdominal/pelvic radiation therapy | RADIATION | 3-D conformal technique. The dose per fraction will be 180cGy, with a total dose of 5040 cGy in 28 fractions. Radiation therapy will be delivered on days 1-18 and days 29-46 |
| Pancreaticoduodenectomy | PROCEDURE | Surgery performed if subject is considered candidate by protocol definition. |
| bevacizumab | DRUG | 10mg/kg IV on Day 1 Q 2 weeks |
| gemcitabine | DRUG | 1000mg/m2 as fixed-rate infusion at 10mg/m2/min on Day 1 and Q 2 weeks. |
| oxaliplatin | DRUG | 100mg/m2 on Day 2 and Q 2 weeks. |
Inclusion Criteria: Eligible patients must meet the following criteria to be enrolled in the study: 1. Newly diagnosed, stage IV squamous cell lung cancer. This includes patients who present with disseminated metastases, and those with a malignant pleural or pericardial effusion (i.e., formerly st...
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