A Multicenter, Open-Label, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naive, KRAS-Mutant, Metastic Colorectal Cancer (mCRC)
Phase 2/Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer
Both
Colorectal Cancer
Trial Information
A Multicenter, Open-Label, Randomized, Phase 2 Study to Evaluate the Efficacy and Safety of NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naive, KRAS-Mutant, Metastic Colorectal Cancer (mCRC)
Inclusion Criteria:
- metastatic colorectal cancer
- tumor with k-ras mutation
Exclusion Criteria:
- More than 1 prior regimen for treatment of metastatic disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression Free Survival
Outcome Time Frame:
every other cycle
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
08-PIR-03
NCT ID:
NCT00856375
Start Date:
December 2008
Completion Date:
Related Keywords:
- Colorectal Cancer
- colorectal cancer
- Colorectal cancer, second line
- Colorectal Neoplasms
Name | Location |
|---|---|
| Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
| USC Norris Comprehensive Cancer Center | Los Angeles, California 90089 |
| Kaiser Permanente Oncology Clinical Trials | Vallejo, California 94589 |
| Louisville Oncology | Louisville, Kentucky 40202 |
| Pivotal Research Centers | Peoria, Arizona 85381 |
| East Valley Hematology and Oncology Medical Center | Burbank, California 91505 |
| University Hematology Oncology, Inc | Centralia, Illinois 62801 |
| Zale Berstein, MD | Buffalo, New York 14215 |
| Center for Biomedical Research - Oncology | Knoxville, Tennessee 37909 |
