NKTR-102 Versus Irinotecan in Patients With Second-Line, Irinotecan-Naïve, KRAS Mutant, Colorectal Cancer
NCT ID: NCT00856375
Last Updated: 2021-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2008-12-31
2014-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NKTR-102
NKTR-102 IV every 3 weeks
NKTR-102
IV every 3 weeks
irinotecan
irinotecan IV every 3 weeks
irinotecan
IV every 3 weeks
Interventions
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NKTR-102
IV every 3 weeks
irinotecan
IV every 3 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* tumor with k-ras mutation
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Nektar Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Nektar Therapeutics
Locations
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Investigator Site - Peoria
Peoria, Arizona, United States
Investigator Site - Burbank
Burbank, California, United States
Investigator Site - Los Angeles
Los Angeles, California, United States
Investigator Site - Vallejo
Vallejo, California, United States
Investigator Site - Centralia
Centralia, Illinois, United States
Investigator Site - Louisville
Louisville, Kentucky, United States
Investigator Site - Detroit
Detroit, Michigan, United States
Investigator Site - Buffalo
Buffalo, New York, United States
Investigator Site - Knoxville
Knoxville, Tennessee, United States
Investigator Site - Antwerp
Antwerp, , Belgium
Investigator Site - Celle
Celle, , Germany
Investigator Site - Karlsruhe
Karlsruhe, , Germany
Investigator Site - Hyderabad
Hyderabad, Andhra Pradesh, India
Investigator Site - Ahmedabad
Ahmedabad, Gujarat, India
Investigator Site - Bangalore
Bangalore, Karnatak, India
Investigator Site - Bangalore
Bangalore, Karnatak, India
Investigator Site - Kochi
Kochi, Kerata, India
Investigator Site - Mumbai
Mumbai, Maharashtra, India
Investigator Site - Kolkata
Kolkata, West Benagal, India
Investigator Site - Kolkata
Kolkata, West Bengal, India
Investigator Site - Elche
Elche, , Spain
Investigator Site - Madrid
Madrid, , Spain
Investigator Site - Aberdeen
Aberdeen, Scotland, United Kingdom
Investigator Site - Manchester
Manchester, , United Kingdom
Countries
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Other Identifiers
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08-PIR-03
Identifier Type: -
Identifier Source: org_study_id
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