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

Completed · Phase 2

Conditions studied: Tumor, Breast Cancer

In brief

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.

Key facts

Study ID

NCT00802945

Run by

Nektar Therapeutics

People needed

70

Starts

2008-10-01

Expected to finish

2012-01-01

Last updated by the study team

2018-07-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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