A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2016-04-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Camptothecin; Cetuximab; Gedatolisib; Irinotecan

Criteria

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.