Colon Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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.

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

19

Study ID:

NCT01925274

Recruitment Status:

Terminated

Sponsor:

Pfizer

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There are 25 Locations for this study

See Locations Near You

CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield California, 93309, United States
Drug Management Only: UCLA West Medical Pharmacy, Att: Steven L Wong, Pharm D
Los Angeles California, 90095, United States
Drug Management Only: UCLA West Medical Pharmacy
Los Angeles California, 90095, United States
UCLA West Medical Pharmacy
Los Angeles California, 90095, United States
Regulatory Management Only: TRIO-US Central Administration
Los Angeles California, 90095, United States
TRIO-US Central Administration (Regulatory Management only)
Los Angeles California, 90095, United States
TRIO_US
Los Angeles California, 90095, United States
West Valley Hematology/Oncology Med Group
Northridge California, 91328, United States
Siteman Cancer Center - West County
Creve Coeur Missouri, 63141, United States
Barnes-Jewish Hospital
Saint Louis Missouri, 63110, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Siteman Cancer Center - South County
Saint Louis Missouri, 63129, United States
Siteman Cancer Center - St Peters
Saint Peters Missouri, 63376, United States
Regulatory Office: Comprehensive Cancer Centers of Nevada
Henderson Nevada, 89014, United States
Comprehensive Cancer Centers of Nevada
Henderson Nevada, 89052, United States
Comprehensive Cancer Centers of Nevada
Henderson Nevada, 89074, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89128, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89148, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Kadlec Clinic Hematology and Oncology
Kennewick Washington, 99336, United States
Kadlec Medical Center
Richland Washington, 99352, United States
Outpatient Imaging Center
Richland Washington, 99352, United States
Spokane Valley Cancer Center
Spokane Valley Washington, 99216, United States
Medical Oncology Associates, PS
Spokane Washington, 99208, United States
Aichi cancer center central hospital
Nagoya Aichi, 464-8, Japan
National Cancer Center Hospital East
Kashiwa Chiba, 277-8, Japan
National Cancer Center
Goyang-si Gyeonggi-do, 410-7, Korea, Republic of
Seoul National University Hospital / Department of Internal Medicine
Seoul , 110-7, Korea, Republic of
Samsung Medical Center
Seoul , 135-7, Korea, Republic of
Asan Medical Center
Seoul , 138-7, Korea, Republic of
Hospital General Universitario Gregorio Marañón
Madrid , 28009, Spain

How clear is this clinincal trial information?

Study is for people with:

Colon Cancer

Phase:

Phase 2

Estimated Enrollment:

19

Study ID:

NCT01925274

Recruitment Status:

Terminated

Sponsor:


Pfizer

How clear is this clinincal trial information?

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