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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00856375
Recruitment Status : Completed
First Posted : March 5, 2009
Last Update Posted : February 25, 2015
Information provided by (Responsible Party):
Nektar Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: NKTR-102 Drug: irinotecan Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : December 2008
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: NKTR-102
Drug: NKTR-102
IV every 3 weeks

Active Comparator: irinotecan
IV every 3 weeks
Drug: irinotecan
IV every 3 weeks

Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: every other cycle ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • metastatic colorectal cancer
  • tumor with k-ras mutation

Exclusion Criteria:

  • More than 1 prior regimen for treatment of metastatic disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00856375

United States, Arizona
Pivotal Research Centers
Peoria, Arizona, United States, 85381
United States, California
East Valley Hematology and Oncology Medical Center
Burbank, California, United States, 91505
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Kaiser Permanente Oncology Clinical Trials
Vallejo, California, United States, 94589
United States, Illinois
University Hematology Oncology, Inc
Centralia, Illinois, United States, 62801
United States, Kentucky
Louisville Oncology
Louisville, Kentucky, United States, 40202
United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
United States, New York
Zale Berstein, MD
Buffalo, New York, United States, 14215
United States, Tennessee
Center for Biomedical Research - Oncology
Knoxville, Tennessee, United States, 37909
ZNA Middelheim
Antwerp, Belgium, 2020
Chefarzt der Klinik fur Gastroenterologie/GI-Onkologie
Celle, Germany, 29223
Studienzentrale, St. Vicentius Kliniken gAG-Studienzentrale
Karlsruhe, Germany, 48201
MNJ Institute of Oncology and Regional Cancer Centre
Hyderabad, Andra Pradesh, India, 500004
Hemato-Oncology Clinic Ahmedabad PVT. Ltd Vedanta
Ahmedabad, Gujarat, India, 380009
M.S. Ramaiah Memorial Hospital-Gokula Metropolis Clinical Research Centre
Bangalore, Karnatak, India, 560054
Rajalakshmi Multispecialty Hospital
Bangalore, Karnatak, India, 560078
Amrita Institute of Medical Sciences and Reserach Centre-Dept of Oncology
Kochi, Kerata, India, 682041
Shatabdi Superspeciality Hospital
Mumbai, Maharashtra, India, 91-98-50986003
Chittaranjan National Cancer Institute
Kolkata, West Benagal, India, 700026
B.P.Poddar Hospital and Medical Research Ltd.
Kolkata, West Bengal, India, 700053
Hospital General Universitario de Elche
Elche, Spain, 34-966-616250
Hospital Ramon y Cajal
Madrid, Spain, 28034
United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Christie Hospital NHS Foundation Trust
Manchester, United Kingdom, MD20 4BX
Sponsors and Collaborators
Nektar Therapeutics
Study Director: Ivan Gergel, MD Nektar Therapeutics

Responsible Party: Nektar Therapeutics Identifier: NCT00856375     History of Changes
Other Study ID Numbers: 08-PIR-03
First Posted: March 5, 2009    Key Record Dates
Last Update Posted: February 25, 2015
Last Verified: January 2015

Keywords provided by Nektar Therapeutics:
colorectal cancer
Colorectal cancer, second line

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action