A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer
Stopped early · Phase 1/Phase 2
Conditions studied: Metastatic Colorectal Carcinoma
In brief
This is a multicenter, open label Phase 1b/2 study in patients with metastatic colorectal carcinoma. The Phase 1b will identify the dose of the combination of PF-05212384 plus FOLFIRI. The randomized, two-arm Phase 2 portion will compare the efficacy and safety of PF-05212384 plus FOLFIRI to that of bevacizumab plus FOLFIRI. The study population will consist of patients with mCRC previously treated with an oxaliplatin-based regimen in the first line setting or who have progressed within 6 months of the end of an adjuvant oxaliplatin-based regimen.
Key facts
- Study ID
- NCT01937715
- Run by
- Pfizer
- People needed
- 18
- Starts
- 2014-02-01
- Expected to finish
- 2015-08-01
- Last updated by the study team
- 2016-08-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Advanced colorectal carcinoma.
- Progression on prior oxaliplatin-containing regimen used in 1st line setting for mCRC or progression within 6 months of end of oxaliplatin-containing regimen in the adjuvant setting.
- Tumor tissue available at time of screening for molecular profiling.
- Adequate performance status.
- Adequate glucose control, bone marrow, kidney, liver, and heart function.
You may not qualify if…
- Participation in other studies involving investigational drug(s) (Phases 1-4) before the current study begins and/or during study participation.
- Prior irinotecan treatment.
- Prior radiation to the pelvis or abdomen in the metastatic or locally advanced setting.
- History of Gilbert's syndrome.
- Active brain metastases.
- Deep vein thrombosis in the preceding 2 months.
- History of interstitial lung disease.
- RAS (KRAS/NRAS) wild type mCRC not previously treated with an anti-EGFR containing regimen (unless contraindicated or not considered standard practice per clinical site or country guidelines).
Where it is running
- St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare — Fullerton, California, United States
- UCLA Hematology Oncology — Irvine, California, United States
- Drug Management Only: UCLA West Medical Pharmacy, Attn 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, Att: Steven L. Wong, Pharm D. — Los Angeles, California, United States
- Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
- Ronald Regan UCLA Medical Center, Drug Information Center — Los Angeles, California, United States
- TRIO-US Central Administration, Regulatory Management Only — Los Angeles, California, United States
- TRIO-US Central Administration — Los Angeles, California, United States
- TRIO_US — Los Angeles, California, United States
- UCLA Hematology Oncology Administrative Address — Los Angeles, California, United States
- Westwood Bowyer Clinic, Peter Morton Medical Building — Los Angeles, California, United States
- West Valley Hematology/Oncology Med Group — Northridge, California, United States
- UCLA/Pasadena Healthcare — Pasadena, California, United States
- Central Coast Medical Oncology Corporation — Santa Maria, California, United States
- UCLA Hematology Oncology — Santa Monica, California, United States
- UCLA Santa Monica Medical Center & Orthopaedic Hospital — Santa Monica, California, United States
- UCLA/Santa Clarita Valley Cancer Center — Valencia, California, United States
- UCLA Cancer Center — Westlake Village, California, United States
- Comprehensive Cancer Centers of Nevada Research Department — 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 NV — Las Vegas, Nevada, United States
- COmprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
- Comprehensive Cancer Centers for Nevada — Las Vegas, Nevada, United States
Full record on ClinicalTrials.gov
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