Overview

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

Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nektar Therapeutics
Treatments:
Etirinotecan pegol
Criteria
Inclusion Criteria:

1. Inoperable metastatic or locally advanced breast cancer

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:

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

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