A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer



Status:Terminated
Conditions:Colorectal Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2014
End Date:August 2015

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An Open-Label, Multi-Center, Randomized Phase 1b/2 Study Of PF-05212384 Plus 5-Fluorouracil-Leucovorin-Irinotecan (FOLFIRI) Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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).
We found this trial at
44
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220 S Palisade Dr # 204
Santa Maria, California 93454
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2500 Metrohealth Dr
Cleveland, Ohio 44109
(216) 778-7800
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
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Irvine, California 92604
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Kennewick, Washington 99336
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Las Vegas, Nevada 89169
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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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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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Los Angeles, California 90095
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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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Los Angeles, California 90095
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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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Los Angeles, California 90095
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Northridge, California 91328
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Pasadena, California 91105
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Pulyallup, Washington 98374
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Richland, Washington 99352
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Richland, Washington 99352
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San Luis Obispo, California 93401
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Santa Maria, California 93454
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Santa Monica, California 90404
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Seattle, Washington 98122
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101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
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Spokane, Washington 99208
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Spokane Valley, Washington 99216
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Valencia, California 91355
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West Hills, California 91304
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