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 |
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.
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
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
MetroHealth Med Ctr The MetroHealth System is one of the largest, most comprehensive health care...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Los Angeles, California 90095
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Spartanburg Regional Medical Center Spartanburg Regional is an integrated healthcare delivery system that provides care...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials