A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer
Stopped early · Phase 2
Conditions studied: Metastatic Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT01925274
- Run by
- Pfizer
- People needed
- 19
- Starts
- 2013-11-15
- Expected to finish
- 2016-04-06
- Last updated by the study team
- 2019-01-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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]
You may not qualify if…
- 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.
Where it is running
- 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
- Barnes-Jewish Hospital — St Louis, Missouri, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Siteman Cancer Center - South County — St Louis, Missouri, United States
- Regulatory Office: Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
- Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
- Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Roswell Park Cancer Institute — Buffalo, New York, United States
- Kadlec Clinic Hematology and Oncology — Kennewick, Washington, United States
- Kadlec Medical Center — Richland, Washington, United States
- Outpatient Imaging Center — Richland, Washington, United States
- Medical Oncology Associates, PS — Spokane, Washington, United States
- Spokane Valley Cancer Center — Spokane Valley, Washington, United States
Full record on ClinicalTrials.gov
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