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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02697058 | Phase II of BAX2398/5-FU/Calcium Levofolinate in Pancreatic Cancer | PHASE2 | COMPLETED | 84 | — | — | Mar 30, 2016 | Aug 28, 2018 | Jul 25, 2024 | 16 | Japan |
Progression Free Survival (PFS) was defined as the time from randomization to the first documented disease progression based on the independent central review board's assessment using RECIST 1.1 or death due to any cause, whichever occurred first.
| Arm | Type | Description |
|---|---|---|
| Part 1: Safety and PK | EXPERIMENTAL | BAX2398 in combination with 5-FU/calcium levofolinate |
| Part 2: Safety, PK, Efficacy | EXPERIMENTAL | BAX2398 in combination with 5-FU/calcium levofolinate |
| Part 2: 5-FU/calcium levofolinate alone | ACTIVE_COMPARATOR | 5-FU/calcium levofolinate |
| Name | Type | Description |
|---|---|---|
| BAX2398 + 5-FU/calcium levofolinate | BIOLOGICAL | BAX2398 (a liposomal formulation of irinotecan) in combination with 5-FU/calcium levofolinate |
| 5-FU/calcium levofolinate | DRUG | 5-FU/calcium levofolinate alone |
Inclusion Criteria: 1. Participant is ≥20 years of age at the time of screening. 2. Histologically or cytologically confirmed adenocarcinoma of exocrine pancreas 3. Documented metastatic disease 4. Metastatic disease with at least one measurable lesion as defined by RECIST 1.1 guidelines 5. Documen...