Clinical trial · Interventional
A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
An Open-Label, Multi-Center, Randomized Phase 1b/2 Study Of PF-05212384 Plus 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): B2151007 was prematurely discontinued due to Pfizer's change in prioritization for the portfolio and is not due to any safety concerns or regulatory interaction
Summary
Brief summary (as posted)
This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI. The study population will consist of patients with mCRC previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Biological | Bevacizumab | ALIAS |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| FOLFIRI regimen | Drug | FOLFIRI Regimen | ALIAS |
| PF-05212384 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- PF-05212384 plus FOLFIRI
- interventionNames
- Drug: PF-05212384
- Drug: FOLFIRI regimen
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Bevacizumab plus FOLFIRI
- interventionNames
- Biological: Bevacizumab
- Drug: FOLFIRI
Primary outcomes (2)
- measure
- Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle of Therapy
- timeFrame
- Day 1 up to Day 28
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced colorectal carcinoma. * Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting. * Tumor tissue available at time of screening for molecular profiling. * Adequate performance status. * Adequate glucose control, bone marrow, kidney, liver, and heart function. Exclusion Criteria: * Participation in other studies involving investigational drug(s) (Phases 1-4) before the current study begins and/or during study participation. * Prior irinotecan treatment. * Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting. * History of Gilbert's syndrome. * Active brain metastases. * Deep vein thrombosis in the preceding 2 months. * History of interstitial lung disease. * RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).
References
Publications (0)
Data not yet available