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5-Fluoruracil · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Onartuzumab+mFOLFOX6 | EXPERIMENTAL | Participants will receive onartuzumab 10 milligrams per kilogram (mg/kg) intravenous (IV) infusion + mFOLFOX6 (oxaliplatin, folinic acid, and 5-fluoruracil) regimen. Participants will receive a maximum of 12 cycles (each cycle is 14 days) of mFOLFOX6 with onartuzumab. Participants whose disease has not progressed after 12 cycles of mFOLFOX6 with onartuzumab will continue treatment with onartuzumab until disease progression, unacceptable toxicity, or death. |
| Placebo+mFOLFOX6 | PLACEBO_COMPARATOR | Participants will receive onartuzumab matching placebo + mFOLFOX6. Participants will receive a maximum of 12 cycles (each cycle is 14 days) of mFOLFOX6 with placebo. Participants whose disease has not progressed after 12 cycles of mFOLFOX6 with placebo will continue treatment with placebo until disease progression, unacceptable toxicity, or death. |
| Name | Type | Description |
|---|---|---|
| 5-Fluoruracil | DRUG | Participants will receive 5-fluorouracil 400 milligrams per square meter (mg/m\^2) IV bolus and then 2400 mg/m\^2 as a continuous IV infusion over 46-48 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first. |
| Folinic acid | DRUG | Participants will receive folinic acid 400 mg/m\^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first. |
| Onartuzumab | DRUG | Participants will receive onartuzumab 10 mg/kg IV infusion on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment. |
| Oxaliplatin | DRUG | Participants will receive oxaliplatin 85 mg/m\^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first. |
| Placebo | DRUG | Participants will receive onartuzumab matching placebo on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment. |
Inclusion Criteria: * Adenocarcinoma of the stomach or gastroesophageal junction with inoperable, metastatic disease, not amenable to curative therapy * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Life expectancy greater than (\>) 3 months * Presence of tissue sample for I...
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5-Fluoruracil is a small molecule oncology drug that has been studied in gastric cancer. It is being developed by Roche Holding AG. The clinical program includes a Phase 3 trial in metastatic HER2-negative and MET-positive gastroesophageal cancer, where it was evaluated in combination with mFOLFOX6.
5-Fluoruracil is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor of the clinical program for this drug.
5-Fluoruracil is in Phase 3 clinical development. The Phase 3 trial has been completed, and no active trials are currently listed. The drug is investigational and has not been approved by the FDA for the studied indication.
5-Fluoruracil has been evaluated in one completed Phase 3 trial, NCT01662869, titled A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer. The trial enrolled 564 participants across multiple countries.
Yes, the Phase 3 trial of 5-Fluoruracil was biomarker-selected, enrolling participants with metastatic HER2-negative and MET-positive gastroesophageal cancer. This means the study targeted a specific molecular profile.