Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
trifluridine/tipiracil · 1 trial · 1 indication
The primary endpoint is the Overall survival (OS) and is defined as the time between the date of randomization and the date of death caused by any reason or the date of last news if the patient is alive.
| Arm | Type | Description |
|---|---|---|
| Arm A (control arm): trifluridine/tipiracil | ACTIVE_COMPARATOR | Cycle of 28 days 35 mg/m2 by mouth twice daily on Days 1 to 5, 2 days of rest and 35 mg/m2 by mouth twice daily on days 8 to 12 |
| Arm B (experimental arm): trifluridine/tipiracil + fruquintinib | EXPERIMENTAL | Cycle of 28 days For trifluridine/tipiracil: 35 mg/m2 by mouth twice daily on Day 1 to 5, 2 days of rest and 35 mg/m2 by mouth twice daily on days 8 to 12 For fruquintinib: 5 mg by mouth once daily Day 1 to Day 21 (3 weeks) Treatment will be repeated every 4 weeks until radiological disease progression, unacceptable toxicity or patient's refusal. |
| Name | Type | Description |
|---|---|---|
| trifluridine/tipiracil | DRUG | Cycle of 28 days 35 mg/m2 by mouth twice daily on Days 1 to 5, 2 days of rest and 35 mg/m2 by mouth twice daily on days 8 to 12 Treatment will be repeated every 4 weeks until radiological disease progression, unacceptable toxicity or patient's refusal. |
| fruquintinib | DRUG | For fruquintinib: 5 mg by mouth once daily Day 1 to Day 21 (3 weeks) Treatment will be repeated every 4 weeks until radiological disease progression, unacceptable toxicity or patient's refusal. |
Inclusion Criteria: 1. Age ≥ 18 years (patients enrolled gender independently). 2. Histologically proven metastatic adenocarcinoma of the stomach or the esophagogastric junction (GEJ) or esophagus. 3. Prior treatment by two or three lines of treatment for metastatic setting (patients who received a...
Trifluridine/tipiracil is an investigational small molecule being studied for the treatment of metastatic oesogastric adenocarcinoma. It is currently in Phase 3 clinical development, and the ongoing trial is evaluating it in combination with fruquintinib versus trifluridine/tipiracil alone in this patient population.
Trifluridine/tipiracil is a small molecule combination therapy. Trifluridine is a nucleoside analog that incorporates into DNA, disrupting DNA synthesis, while tipiracil inhibits thymidine phosphorylase, preventing the degradation of trifluridine. This mechanism is being studied in metastatic oesogastric adenocarcinoma.
Trifluridine/tipiracil is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting a Phase 3 clinical trial of the drug in metastatic oesogastric adenocarcinoma.
Trifluridine/tipiracil is in Phase 3 clinical development for metastatic oesogastric adenocarcinoma. It is an investigational drug and has not been approved for this indication. The ongoing Phase 3 trial is actively recruiting participants.
Trifluridine/tipiracil is being studied in the Phase 3 clinical trial NCT07270991, titled "Trifluridine/Tipiracil + Fruquintinib Versus Trifluridine/Tipiracil Alone for Metastatic Oeso-gastric Adenocarcinoma." This randomized, active-controlled trial is recruiting 324 participants in France and Germany.
Trifluridine/tipiracil is a combination of two active ingredients, trifluridine and tipiracil. The drug is also known by the brand name Lonsurf. In the context of this clinical trial, it is being evaluated as a single agent and in combination with fruquintinib for metastatic oesogastric adenocarcinoma.