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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 used in the treatment of gastric cancer. It is being studied in combination with mFOLFOX6 for patients with metastatic HER2-negative and MET-positive gastroesophageal cancer. The drug is currently in Phase 3 clinical development for this indication.
5-Fluoruracil is a small molecule that works by inhibiting thymidylate synthase, an enzyme involved in DNA synthesis. By blocking this enzyme, the drug disrupts the production of DNA in cancer cells, leading to their death. This mechanism makes it effective in treating gastric cancer.
5-Fluoruracil is developed by Roche Holding AG, a multinational healthcare company. The company is conducting clinical trials to evaluate the drug's efficacy in treating gastric cancer. Roche's ticker symbol is RHHBY.
5-Fluoruracil is currently in Phase 3 clinical development for gastric cancer. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial is completed, with results expected to inform potential regulatory submissions.
5-Fluoruracil is being studied in a Phase 3 clinical trial with the identifier NCT01662869. This trial, titled 'A Study of Onartuzumab in Combination With mFOLFOX6 in Participants With Metastatic HER2-Negative and MET-Positive Gastroesophageal Cancer,' enrolled 564 participants and has been completed.
Yes, 5-Fluoruracil is the same as fluorouracil. It is a chemotherapy drug used in the treatment of various cancers, including gastric cancer. The drug is being evaluated in combination with other agents to improve outcomes for patients with gastroesophageal cancer.