Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer
NCT ID: NCT00802945
Last Updated: 2018-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
70 participants
INTERVENTIONAL
2008-10-31
2012-01-31
Brief Summary
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Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may be evaluated in this study with approximately 35 patients enrolled in each treatment arm.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NKTR-102 q14d
NKTR-102
NKTR-102
NKTR-102 given on a q14 day schedule
NKTR-102 q21d
NKTR-102
NKTR-102
NKTR-102 given on a q21 day schedule
Interventions
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NKTR-102
NKTR-102 given on a q14 day schedule
NKTR-102
NKTR-102 given on a q21 day schedule
Eligibility Criteria
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Inclusion Criteria
2. No more than 2 prior chemotherapy regimens given in a metastatic or locally advanced setting and prior treatment in the metastatic setting must have included a taxane
Exclusion Criteria
2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle or minor surgery within 2 weeks prior to Day 1 of Cycle 1
18 Years
ALL
No
Sponsors
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Nektar Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Alison Hannah, MD
Role: STUDY_DIRECTOR
Nektar Therapeutics
Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States
Stockton Hematology/Oncology
Stockton, California, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Louisville Oncology Clinical Research Program
Louisville, Kentucky, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Pharma Resource
East Providence, Rhode Island, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Institut Jules Bordet
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
De Pintelaan 1885
Ghent, , Belgium
CHU de Liege
Liège, , Belgium
GasthuisZusters Antwerpen
Wilrijk, , Belgium
Clatterbridge Centre for Oncology
Bebington, , United Kingdom
Velindre Hospital
Cardiff, , United Kingdom
Beatson Oncology Center
Glasgow, , United Kingdom
St James University Hospital
Leed, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Weston Park Hospital
Sheffield, , United Kingdom
Countries
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References
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Awada A, Garcia AA, Chan S, Jerusalem GH, Coleman RE, Huizing MT, Mehdi A, O'Reilly SM, Hamm JT, Barrett-Lee PJ, Cocquyt V, Sideras K, Young DE, Zhao C, Chia YL, Hoch U, Hannah AL, Perez EA; NKTR-102 Study Group. Two schedules of etirinotecan pegol (NKTR-102) in patients with previously treated metastatic breast cancer: a randomised phase 2 study. Lancet Oncol. 2013 Nov;14(12):1216-25. doi: 10.1016/S1470-2045(13)70429-7. Epub 2013 Oct 4.
Other Identifiers
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08-PIR-05
Identifier Type: -
Identifier Source: org_study_id
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