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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Nektar Therapeutics
Sponsor:
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT00856375
First received: March 3, 2009
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Colorectal Cancer
Drug: NKTR-102
Drug: irinotecan
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Nektar Therapeutics:

Primary Outcome Measures:
  • Progression Free Survival [ Time Frame: every other cycle ] [ Designated as safety issue: No ]

Estimated Enrollment: 174
Study Start Date: December 2008
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NKTR-102
NKTR-102
Drug: NKTR-102
IV every 3 weeks
Active Comparator: irinotecan
IV every 3 weeks
Drug: irinotecan
IV every 3 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • metastatic colorectal cancer
  • tumor with k-ras mutation

Exclusion Criteria:

  • More than 1 prior regimen for treatment of metastatic disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856375

Contacts
Contact: Robert Medve, MD 415-482-5300
Contact: Charleen Jue, B.S. 415-482-5300

Locations
United States, Arizona
Pivotal Research Centers Terminated
Peoria, Arizona, United States, 85381
United States, California
East Valley Hematology and Oncology Medical Center Recruiting
Burbank, California, United States, 91505
Contact: Christine Marion    213-989-1888 ext 12      
Principal Investigator: Maurice Berkowitz, MD         
USC Norris Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90033
Contact: Carol Jones    323-865-0460      
Principal Investigator: Heinz-Josef Lenz, MD         
Kaiser Permanente Oncology Clinical Trials Recruiting
Vallejo, California, United States, 94589
Contact: Desiree Goldstein    707-651-2797      
Principal Investigator: Tatjana Kolevska, MD         
United States, Illinois
University Hematology Oncology, Inc Terminated
Centralia, Illinois, United States, 62801
United States, Kentucky
Louisville Oncology Recruiting
Louisville, Kentucky, United States, 40202
Contact: Pamela Adkisson    502-629-3607      
Principal Investigator: John Hamm, MD         
United States, Michigan
Barbara Ann Karmanos Cancer Institute Recruiting
Detroit, Michigan, United States, 48201
Contact: Anne Marie Ferris    313-576-9373      
Principal Investigator: Philip Philip, MD         
United States, New York
Zale Berstein, MD Terminated
Buffalo, New York, United States, 14215
United States, Tennessee
Center for Biomedical Research - Oncology Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Susan Owenby    865-934-2672      
Principal Investigator: Tracy Dobbs, MD         
Belgium
ZNA Middelheim Terminated
Antwerp, Belgium, 2020
Germany
Chefarzt der Klinik fur Gastroenterologie/GI-Onkologie Terminated
Celle, Germany, 29223
Studienzentrale, St. Vicentius Kliniken gAG-Studienzentrale Recruiting
Karlsruhe, Germany, 48201
Contact: Birgit Koch    49-721-81013003      
Principal Investigator: Jorg Mezger, MD         
India
MNJ Institute of Oncology and Regional Cancer Centre Terminated
Hyderabad, Andra Pradesh, India, 500004
Hemato-Oncology Clinic Ahmedabad PVT. Ltd Vedanta Terminated
Ahmedabad, Gujarat, India, 380009
M.S. Ramaiah Memorial Hospital-Gokula Metropolis Clinical Research Centre Terminated
Bangalore, Karnatak, India, 560054
Rajalakshmi Multispecialty Hospital Terminated
Bangalore, Karnatak, India, 560078
Amrita Institute of Medical Sciences and Reserach Centre-Dept of Oncology Terminated
Kochi, Kerata, India, 682041
Shatabdi Superspeciality Hospital Terminated
Mumbai, Maharashtra, India, 91-98-50986003
Chittaranjan National Cancer Institute Terminated
Kolkata, West Benagal, India, 700026
B.P.Poddar Hospital and Medical Research Ltd. Terminated
Kolkata, West Bengal, India, 700053
Spain
Hospital General Universitario de Elche Terminated
Elche, Spain, 34-966-616250
Hospital Ramon y Cajal Terminated
Madrid, Spain, 28034
United Kingdom
Aberdeen Royal Infirmary Active, not recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Christie Hospital NHS Foundation Trust Active, not recruiting
Manchester, United Kingdom, MD20 4BX
Sponsors and Collaborators
Nektar Therapeutics
  More Information

No publications provided

Responsible Party: Nektar Therapeutics
ClinicalTrials.gov Identifier: NCT00856375     History of Changes
Other Study ID Numbers: 08-PIR-03
Study First Received: March 3, 2009
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

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
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Irinotecan
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014