Breast Cancer Clinical Trial

Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer

Summary

This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based treatment in the metastatic setting.

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Inoperable metastatic or locally advanced breast cancer
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:

Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1
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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT00802945

Recruitment Status:

Completed

Sponsor:

Nektar Therapeutics

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There are 19 Locations for this study

See Locations Near You

USC Norris Comprehensive Cancer Center
Los Angeles California, 90089, United States
Desert Hematology Oncology Medical Group
Rancho Mirage California, 92270, United States
Stockton Hematology/Oncology
Stockton California, 95204, United States
Mayo Clinic Jacksonville
Jacksonville Florida, 32224, United States
Louisville Oncology Clinical Research Program
Louisville Kentucky, 40207, United States
Mayo Clinic Rochester
Rochester Minnesota, 55905, United States
Pharma Resource
East Providence Rhode Island, 02915, United States
University of Virginia Health System
Charlottesville Virginia, 22908, United States
Institut Jules Bordet
Bruxelles , 2-2-5, Belgium
UZ Antwerpen
Edegem , 2650, Belgium
De Pintelaan 1885
Gent , 9000, Belgium
CHU de Liege
Liege , 4000, Belgium
GasthuisZusters Antwerpen
Wilrijk , 2610, Belgium
Clatterbridge Centre for Oncology
Bebington , CH63 , United Kingdom
Velindre Hospital
Cardiff , CH14 , United Kingdom
Beatson Oncology Center
Glasgow , G12 O, United Kingdom
St James University Hospital
Leed , LS97T, United Kingdom
Nottingham City Hospital
Nottingham , NG5 1, United Kingdom
Weston Park Hospital
Sheffield , S10 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

70

Study ID:

NCT00802945

Recruitment Status:

Completed

Sponsor:


Nektar Therapeutics

How clear is this clinincal trial information?

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