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

Status:	Completed
Conditions:	Breast Cancer, Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	7/11/2018
Start Date:	October 2008
End Date:	January 2012

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Safety and Efficacy of NKTR-102 When Given on a Q14 Day or a Q21 Day Schedule in Patients With Metastatic or Locally Advanced Breast Cancer Whose Disease Has Failed Prior Taxane-Based Treatment

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.

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

We found this trial at

sites

Institut Jules Bordet

Bruxelles,

4933

from 98109

Bruxelles,