NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naïve, KRAS Mutant, Colorectal Cancer
This study is currently recruiting participants.
Verified April 2013 by Nektar Therapeutics
Sponsor:
Nektar Therapeutics
Information provided by (Responsible Party):
Nektar Therapeutics
ClinicalTrials.gov Identifier:
NCT00856375
First received: March 3, 2009
Last updated: April 30, 2013
Last verified: April 2013
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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, Metastic 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
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 | Recruiting |
| Centralia, Illinois, United States, 62801 | |
| Contact: Lynn Ann Waggoner-Pigg 618-532-1891 | |
| Principal Investigator: James Hayes, MD | |
| 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 | Recruiting |
| Ahmedabad, Gujarat, India, 380009 | |
| Contact: Darshil Shah 079-40042223 | |
| Principal Investigator: Sandeep Shah, MD | |
| 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 | Recruiting |
| Mumbai, Maharashtra, India, 91-98-50986003 | |
| Contact: Shalaka Tamane 91-9850986003 | |
| Principal Investigator: Shailesh Bondarde, MD | |
| Chittaranjan National Cancer Institute | Recruiting |
| Kolkata, West Benagal, India, 700026 | |
| Contact: Subhabrata Dey 91-9831159789 | |
| Principal Investigator: Kalyan Mukherjee, MD | |
| B.P.Poddar Hospital and Medical Research Ltd. | Recruiting |
| Kolkata, West Bengal, India, 700053 | |
| Contact: Piyali Das 91-9903618772 | |
| Principal Investigator: Chanchal Goswami, MD | |
| 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 | Recruiting |
| Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
| Contact: Pauline Killham 44-1224-554361 | |
| Principal Investigator: Leslie Samuel, MD | |
| Christie Hospital NHS Foundation Trust | Recruiting |
| Manchester, United Kingdom, MD20 4BX | |
| Contact: Karen Palmer 44-161-446-3357 | |
| Principal Investigator: Mark Saunders, MD | |
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: | April 30, 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 Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013