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

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Nektar Therapeutics

Status and phase

Completed
Phase 2

Conditions

Colorectal Cancer

Treatments

Drug: irinotecan
Drug: NKTR-102

Study type

Interventional

Funder types

Industry

Identifiers

NCT00856375
08-PIR-03

Details and patient eligibility

About

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.

Full description

NKTR-102 (Topoisomerase I Inhibitor Polymer Conjugate) is a polyethylene glycol (PEG) conjugate of irinotecan. Irinotecan is a topoisomerase I inhibitor approved worldwide. In the US, irinotecan is indicated as a component of first-line therapy in combination with 5 fluorouracil (5 FU) and leucovorin for patients with metastatic carcinoma of the colon or rectum. Irinotecan is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Second-line therapy for colorectal cancer typically involves cetuximab and irinotecan. However, growing evidence indicates that cetuximab (or other EGFR inhibitors) is not appropriate therapy for patients with mutant KRAS. For these patients, irinotecan may be appropriate as a single agent, and a new therapy that could improve upon efficacy and safety would provide an important option for the treatment of advanced colorectal cancer.

Enrollment

83 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • metastatic colorectal cancer
  • tumor with k-ras mutation

Exclusion criteria

More than 1 prior regimen for treatment of metastatic disease

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

83 participants in 2 patient groups

NKTR-102
Experimental group
Description:
NKTR-102 IV every 3 weeks
Treatment:
Drug: NKTR-102
irinotecan
Active Comparator group
Description:
irinotecan IV every 3 weeks
Treatment:
Drug: irinotecan

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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