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Modified FOLFOX6 · 1 trial · 9 indications
An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment.
A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal, * life threatening (places the participant at immediate risk of death), * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other medically important serious event.
| Arm | Type | Description |
|---|---|---|
| Conatumumab Monotherapy | EXPERIMENTAL | Participants will continue to receive conatumumab every 2 weeks (Q2W) or every 3 weeks (Q3W) at the same dose and regimen as at the conclusion of the parent study. |
| Conatumumab + Ganitumab | EXPERIMENTAL | Participants will receive conatumumab and ganitumab by intravenous infusion at the same dose and regimen as at the conclusion of the parent study. |
| Ganitumab Monotherapy | EXPERIMENTAL | Participants will continue to receive ganitumab Q3W or every 4 weeks (Q4W) at the same dose and regimen as at the conclusion of the parent study. |
| Conatumumab + mFOLFOX6 ± Bevacizumab | EXPERIMENTAL | Participants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab. |
| Name | Type | Description |
|---|---|---|
| Modified FOLFOX6 | DRUG | The mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m² administered as a 2-hour intravenous (IV) infusion on day 1 and leucovorin 400 mg/m² racemate or 200 mg/m² levo-leucovorin administered as a 2-hour infusion on day 1, followed by a loading dose of 5-fluorouracil (5-FU) 400 mg/m² IV bolus administered on day 1, then 5-FU 2400 mg/m² via ambulatory pump administered for a period of 46 to 48 hours every 14 days. |
| Conatumumab | BIOLOGICAL | Administered by intravenous infusion Q2W or Q3W. |
| Ganitumab | BIOLOGICAL | Administered by intravenous infusion Q3W or Q4W. |
| Bevacizumab | BIOLOGICAL | Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle. |
Inclusion Criteria: * To be enrolled in this study, subjects must be currently enrolled in a prior Amgen-sponsored conatumumab or AMG 479 study and are eligible according to the parent study to receive their next dose of conatumumab (with or without co-therapy), or AMG 479 alone. Subjects must hav...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Modified FOLFOX6 is a chemotherapy regimen being studied for the treatment of advanced solid tumors, including carcinoid, colorectal cancer, locally advanced tumors, lymphoma, metastatic cancer, non-small cell lung cancer, and sarcoma. It is currently in Phase 2 clinical development as an investigational treatment.
Modified FOLFOX6 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The company is conducting clinical research to evaluate this chemotherapy regimen in patients with advanced solid tumors.
Modified FOLFOX6 is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and efficacy in treating advanced solid tumors.
Modified FOLFOX6 is associated with clinical trial NCT01327612, titled "Open Label Extension Study of Conatumumab and Ganitumab (AMG 479)." This Phase 2 study has been completed and enrolled 12 participants with advanced solid tumors across the United States, Poland, and Spain.
Modified FOLFOX6 is a specific variant of the FOLFOX chemotherapy regimen, which typically includes folinic acid, fluorouracil, and oxaliplatin. The "modified" designation indicates adjustments to the standard dosing schedule. It is being studied in combination with other agents in clinical trials for advanced solid tumors.