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

TERMINATEDPHASE2

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

NCT01925274•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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.

Locations (32)

CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

Bakersfield, California, United States

Drug Management Only: UCLA West Medical Pharmacy, Att: Steven L Wong, Pharm D

Los Angeles, California, United States

Drug Management Only: UCLA West Medical Pharmacy

Los Angeles, California, United States

UCLA West Medical Pharmacy

Los Angeles, California, United States

Regulatory Management Only: TRIO-US Central Administration

Los Angeles, California, United States

TRIO-US Central Administration (Regulatory Management only)

Los Angeles, California, United States

TRIO_US

Los Angeles, California, United States

West Valley Hematology/Oncology Med Group

Northridge, California, United States

Siteman Cancer Center - St Peters

City of Saint Peters, Missouri, United States

Siteman Cancer Center - West County

Creve Coeur, Missouri, United States

Key Dates

Start Date

November 15, 2013

Primary Completion Date

April 6, 2016

Completion Date

April 6, 2016

Last Updated

January 8, 2019

Enrollment

19

ACTUAL participants

Conditions

Metastatic Colorectal Cancer

Interventions

PF-05212384

DRUG

irinotecan

DRUG

Cetuximab

DRUG

Irinotecan

DRUG

Sponsors

Lead Sponsor

Pfizer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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