Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04511039 | Trifluridine/Tipiracil and Talazoparib for the Treatment of Patients With Locally Advanced or Metastatic Colorectal or Gastroesophageal Cancer | PHASE1 | RECRUITING | 45 | — | — | Jun 8, 2021 | Apr 1, 2029 | May 4, 2026 | 1 | United States |
All adverse events will be evaluated using Common Terminology Criteria for All Adverse Events (CTCAE) version (v.) 5.
Will utilize the keyboard design - a novel model- assisted dose-finding method to find the maximum tolerated dose
| Arm | Type | Description |
|---|---|---|
| Treatment Arm | EXPERIMENTAL | Patients receive trifluridine/tipiracil PO BID and talazoparib tosylate PO QD on days 1-5. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| Trifluridine and Tipiracil Hydrochloride | DRUG | Given PO |
| Talazoparib Tosylate | DRUG | Given PO |
Inclusion Criteria: * Histologically or cytologically confirmed CRC or EGC adenocarcinoma that is locally advanced or metastatic (Cohort A); histologically or cytologically confirmed p53mt/RASonc (Cohort B1) or p53mt/RASwt CRC (Cohort B2) that is locally advanced or metastatic. Patients with adenoc...