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



Status:Terminated
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:November 15, 2013
End Date:April 6, 2016

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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

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.


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.
We found this trial at
25
sites
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Bakersfield, CA
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Creve Coeur, Missouri 63141
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Henderson, NV
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Kennewick, Washington 99336
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Kennewick, WA
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Las Vegas, NV
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Las Vegas, NV
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Los Angeles, CA
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Los Angeles, California 90095
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Los Angeles, California 90095
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Los Angeles, California 90095
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Nagoya,
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Northridge, California 91328
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Northridge, CA
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Richland, Washington 99352
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Richland, WA
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Richland, Washington 99352
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Saint Louis, Missouri 63129
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Saint Louis, Missouri 63110
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Saint Louis, MO
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Peters, Missouri 63376
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Spokane, Washington 99208
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Spokane Valley, Washington 99216
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