Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as FOLFOX 4, FOLFOX 5, Modified FOLFOX 6, FOLFOX 7, Oxaliplatin
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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Oxaliplatin based chemotherapy is used to treat colorectal cancer. It is a small molecule chemotherapy regimen studied in a Phase 3 trial in patients with advanced colorectal cancer. The regimen was evaluated in combination with other agents in the PACCE study, which enrolled 1,053 patients aged 18 years and older.
Amgen Inc. (ticker: AMGN) is the developer associated with the oxaliplatin based chemotherapy program in colorectal cancer. Amgen sponsored the Phase 3 PACCE trial evaluating the regimen in advanced colorectal cancer, a study that has been completed.
Oxaliplatin based chemotherapy in colorectal cancer is in Phase 3 development. The single registered trial, PACCE (NCT00115765), is a completed Phase 3 study. It is an active-controlled, randomized trial that enrolled 1,053 patients and was not double blinded.
Oxaliplatin based chemotherapy has been studied in the Phase 3 PACCE trial, registered as NCT00115765. The trial is titled Panitumumab Advanced Colorectal Cancer Evaluation Study and enrolled 1,053 patients with colorectal cancer. It is a randomized, active-controlled study that has been completed, with no trials currently active.
Oxaliplatin based chemotherapy is an investigational regimen in the colorectal cancer program sponsored by Amgen Inc. The available development record shows a completed Phase 3 trial, NCT00115765, and no active trials. It is a small molecule chemotherapy approach evaluated in combination with other agents in advanced colorectal cancer.