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 |
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.
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
Los Angeles, California 90095
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
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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9280 W. Sunset Road
Suite 100
Las Vegas, Nevada 89148
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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660 S Euclid Ave
Saint Louis, Missouri 63110
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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