NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naïve, KRAS Mutant, Colorectal Cancer

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.

Timeline

Start

2008-12

Primary completion

2014-07

Completion

2014-12

Outcome

Missed primary endpoint

registry MEDIAN NKTR-102: 4.0 (2.7 to 5.9) months NCT00856375 ↗

registry analysis (other test); NKTR-102 vs Irinotecan; p = 0.07; Hazard Ratio (HR) 0.645 (95% CI 0.4 to 1.041); Log Rank NCT00856375 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Etirinotecan Pegol	Other / unclassified	—	Intravenous
Comparator	Irinotecan	Small molecule	—	Intravenous

Indications