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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03043547 | Nal-IRI and 5-FU Compared to 5-FU in Patients With Cholangio- and Gallbladder Carcinoma Previously Treated With Gemcitabine-based Therapies | PHASE2 | COMPLETED | 100 | — | — | Oct 24, 2017 | Mar 8, 2022 | May 18, 2022 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| Nal-IRI + 5-FU + leucovorin (Arm A) | EXPERIMENTAL | nal-IRI \[Irinotecan liposome\] (80 mg/m2 as a 1.5 hour infusion), 5-FU \[5-Fluorouracil\] (2400 mg/m2 as 46 hour infusion) and leucovorin (400 mg/m2 as 0.5 hour infusion) (q2w) |
| 5-FU + leucovorin (Arm B) | OTHER | Control intervention/standard arm: 5-FU (2400 mg/m2 as 46 hour infusion) and leucovorin (400 mg/m2 as 0.5 hour infusion) (q2w) |
| Name | Type | Description |
|---|---|---|
| nal-IRI | DRUG | nal-IRI \[Irinotecan liposome\] (80 mg/m2 as a 1.5 hour infusion) |
| 5-FU | DRUG | 5-FU \[5-Fluorouracil\] (2400 mg/m2 as 46 hour infusion) |
| leucovorin | DRUG | leucovorin (400 mg/m2 as 0.5 hour infusion) |
Inclusion Criteria: 1. Written informed consent incl. participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 2. Age ≥ 18 years...