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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 InstituteDetroit, Michigan  48201
USC Norris Comprehensive Cancer CenterLos Angeles, California  90089
Kaiser Permanente Oncology Clinical TrialsVallejo, California  94589
Louisville OncologyLouisville, Kentucky  40202
Pivotal Research CentersPeoria, Arizona  85381
East Valley Hematology and Oncology Medical CenterBurbank, California  91505
University Hematology Oncology, IncCentralia, Illinois  62801
Zale Berstein, MDBuffalo, New York  14215
Center for Biomedical Research - OncologyKnoxville, Tennessee  37909