Overview

This trial is active, not recruiting.

Condition colorectal cancer
Treatments nktr-102, irinotecan
Phase phase 2/phase 3
Sponsor Nektar Therapeutics
Start date December 2008
End date August 2014
Trial size 174 participants
Trial identifier NCT00856375, 08-PIR-03

Summary

This study will evaluate whether NKTR-102, an investigational drug has an anti-tumor effect in patients with colorectal cancer. This study will also evaluate how the safety and anti-tumor activity of NKTR-102 compares with irinotecan, a cancer drug that is approved for use in the US for treatment of patients with certain types of colorectal cancer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
NKTR-102
nktr-102
IV every 3 weeks
(Active Comparator)
IV every 3 weeks
irinotecan
IV every 3 weeks

Primary Outcomes

Measure
Progression Free Survival
time frame: every other cycle

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - metastatic colorectal cancer - tumor with k-ras mutation Exclusion Criteria: - More than 1 prior regimen for treatment of metastatic disease

Additional Information

Official title 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, Metastatic Colorectal Cancer (mCRC)
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Nektar Therapeutics.