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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
Open (Enrolling)
Both
Colorectal Cancer

Thank you

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