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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06625320 | Phase 3 Study of Daraxonrasib (RMC-6236) in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) | PHASE3 | ACTIVE NOT_RECRUITING | 500 | — | — | Oct 16, 2024 | Dec 1, 2027 | Jun 2, 2026 | 60 | United States, France +5 |
PFS is defined as the time from randomization until disease progression or death from any cause, whichever occurs first. Progression is per response evaluation criteria in solid tumors (RECIST) v1.1 and as assessed by blinded independent central review (BICR)
OS is defined as the time from randomization until death from any cause.
| Arm | Type | Description |
|---|---|---|
| RMC-6236 | EXPERIMENTAL | Study drug |
| Investigator's choice of standard of care therapy | ACTIVE_COMPARATOR | Patients randomized to Investigator's choice of standard of care chemotherapy will receive one of the following four treatments: * Gemcitabine and nab-paclitaxel (GnP) * Oxaliplatin, leucovorin, irinotecan, and 5-FU (Modified FOLFIRINOX: mFOLFIRINOX) * Liposomal irinotecan (Nal-IRI + 5-FU/LV) * Oxaliplatin, leucovorin and 5-FU IV (FOLFOX) |
| Name | Type | Description |
|---|---|---|
| RMC-6236 | DRUG | Oral Tablets |
| Gemcitabine | DRUG | intravenous (IV) infusion |
| nab-paclitaxel | DRUG | IV infusion |
| Irinotecan | DRUG | IV infusion |
| Liposomal irinotecan | DRUG | IV infusion |
| 5-fluorouracil | DRUG | IV infusion |
| leucovorin | DRUG | IV infusion |
| Oxaliplatin | DRUG | IV infusion |
Inclusion Criteria: * At least 18 years old and has provided informed consent. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Histologically or cytologically confirmed PDAC with metastatic disease. * Measurable disease per RECIST 1.1. * Adequate organ function (bone mar...