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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06225999 | Phase 2 Study of Irinotecan Liposome Injection, Oxaliplatin, 5-fluorouracil/Levoleucovorin in Japanese Participants Not Previously Treated for Metastatic Adenocarcinoma of the Pancreas | PHASE2 | COMPLETED | 41 | — | — | Apr 25, 2024 | Sep 29, 2025 | May 18, 2026 | 14 | Japan |
OR is defined as complete response (CR) or partial response (PR), as assessed by the independent central review (ICR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
| Arm | Type | Description |
|---|---|---|
| Irinotecan liposome Injection in combination with oxaliplatin, 5-FU and LLV | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Irinotecan liposome injection (S095013) | DRUG | Irinotecan liposome injection (S095013) will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. |
| Oxaliplatin | DRUG | Oxaliplatin will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. |
| LLV (levoisomer form of leucovorin) | DRUG | LLV will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. |
| 5- FU (5-Fluorouracil) | DRUG | 5-FU will be administered via intravenous (IV) infusion on days 1 and 15 of each 28-day cycle. |
Inclusion Criteria: * Male or non-pregnant and non-lactating female ≥ 18 years of age. * Histologically or cytologically confirmed adenocarcinoma of the pancreas that has not been previously treated in the metastatic setting. * Initial diagnosis of metastatic disease (as per American Joint Committe...