Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Oxaliplatin Based Chemotherapy · 1 trial · 1 indication
Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression
Objective tumor response (complete or partial) rate through week 12 based on central review in the Irinotecan stratum
| Arm | Type | Description |
|---|---|---|
| Oxaliplatin and bevacizumab without panitumumab | ACTIVE_COMPARATOR | Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone. |
| Irinotecan and bevacizumab plus panitumumab | EXPERIMENTAL | Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W |
| Irinotecan and bevacizumab without panitumumab | ACTIVE_COMPARATOR | Irinotecan-based chemotherapy and Bevacizumab Q2W alone |
| Oxaliplatin and bevacizumab plus panitumumab | EXPERIMENTAL | Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6mg/kg Q2W |
| Name | Type | Description |
|---|---|---|
| Oxaliplatin Based Chemotherapy | DRUG | Oxaliplatin-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) consisting of Oxaliplatin, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. |
| Panitumumab | DRUG | PanitumumabPanitumumab is a high affinity (Kd = 5 x 10-11 M) fully human IgG2 monoclonal antibody that is directed against the human EGFr. Panitumumab will be administered by a 30-60 minute IV infusion at a dose of 6 mg/kg once every 2 weeks on the same day of the oxaliplatin- or irinotecan-based chemotherapy and bevacizumab. |
| Irinotecan Based Chemotherapy | DRUG | Irinotecan-based Chemotherapy Every 2 Week Regimens (Q2W Cycles) - Irinotecan, Leucovorin (LV), 5-Fluorouracil (5-FU) - To be determined by physician. On Day 1 irinotecan and LV are given at the same time using different bags and a Y-line followed by 5-FU administration. |
| Bevacizumab | DRUG | Bevacizumab is a vascular endothelial growth factor (VEGF)-targeted antibody therapy that was administered to subjects intravenously Q2 weeks as per usual standard of care on the same day of chemotherapy and panitumumab administration . |
Inclusion Criteria: * Adenocarcinoma of the colon or rectum * Metastatic colorectal cancer (mCRC) * Measurable disease per modified response evaluation criteria in solid tumors (RECIST) criteria * ECOG performance status of 0 or 1 * Available paraffin-embedded tumor tissue (from primary tumor or me...
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