A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer
NCT01925274
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- 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]
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer | ||||||
Official Title ICMJE | 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 | ||||||
Brief 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Metastatic Colorectal Cancer | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Terminated | ||||||
Actual Enrollment ICMJE | 19 | ||||||
Original Estimated Enrollment ICMJE | 150 | ||||||
Actual Study Completion Date ICMJE | April 6, 2016 | ||||||
Actual Primary Completion Date | April 6, 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Japan, Korea, Republic of, Spain, United States | ||||||
Removed Location Countries | Belgium, Italy | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01925274 | ||||||
Other Study ID Numbers ICMJE | B2151005 2013-002095-40 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | December 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |