Clinical trial · Interventional
A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer
A RANDOMIZED PHASE 2 STUDY OF PF-05212384 PLUS IRINOTECAN VERSUS CETUXIMAB PLUS IRINOTECAN IN PATIENTS WITH KRAS AND NRAS WILD TYPE 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): Enrollment to the study was terminated on 11Nvo2014 due to slow recruitment. There were no safety or efficacy issues that contributed to this decision.
Summary
Brief summary (as posted)
This study will investigate whether the combination of PF-05212384 plus Irinotecan improves progression free survival in patients with KRAS and NRAS wild type metastatic colorectal cancer when compared with the combination of cetuximab plus Irinotecan. A Japanese Lead in Cohort will assess the safety of the combination of PF-05212384 + irinotecan in patients enrolled at Japanese sites.
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 Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| irinotecan | Drug | Irinotecan | ALIAS |
| PF-05212384 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- PF-05212384 plus Irinotecan
- interventionNames
- Drug: PF-05212384
- Drug: irinotecan
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Cetuximab plus Irinotecan
- interventionNames
- Drug: Cetuximab
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) as Assessed by Investigators
- timeFrame
- From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * KRAS and NRAS wild type metastatic colorectal cancer * Progression following treatment for colorectal cancer with irinotecan, oxaliplatin and fluoropyrimidine therapy in the metastatic setting. * Eastern Cooperative Oncology Group \[ECOG\] Performance Status of 0, 1, or 2 * At least one measurable lesion by Response Evaluation Criterion in Solid Tumors \[RECIST\] Exclusion Criteria: * More than 2 prior cytotoxic chemotherapy regimens for metastatic colorectal cancer. * Prior treatment with a PI3K, mTOR, AKT or EGFR inhibitor * Patients who have discontinued treatment with prior irinotecan therapy due to toxicity. * Prior radiation to the pelvis or abdomen * Patients with history of interstitial lung disease.
References
Publications (0)
Data not yet available