drugset / Trial / NCT01925274

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

NCT01925274 ↗

Phase 2 Terminated 19 enrolled Pfizer
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2013-11-15
Primary completion
2016-04-06
Completion
2016-04-06

Outcome

Outcome not reported

Stopped (Enrollment): “Enrollment to the study was terminated on 11Nvo2014 due to slow recruitment. There were no safety or efficacy issues that contributed to this decision.”

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cetuximab Monoclonal antibody 400 mg/m2 Intravenous
Subject Gedatolisib Small molecule 110 mg Intravenous
Background Irinotecan Small molecule 180 mg/m2 Intravenous

Indications