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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Tumor, Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate (ORR) as determined by the Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

12 Months

Safety Issue:

No

Principal Investigator

Robert Medve, MD

Investigator Role:

Study Director

Investigator Affiliation:

Nektar Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

08-PIR-05

NCT ID:

NCT00802945

Start Date:

October 2008

Completion Date:

January 2012

Related Keywords:

  • Tumor
  • Breast Cancer
  • Breast Neoplasms

Name

Location

Mayo Clinic JacksonvilleJacksonville, Florida  32224
USC Norris Comprehensive Cancer CenterLos Angeles, California  90089
Mayo Clinic RochesterRochester, Minnesota  55905
University of Virginia Health SystemCharlottesville, Virginia  22903
Desert Hematology Oncology Medical GroupRancho Mirage, California  92270
Stockton Hematology/OncologyStockton, California  95204
Louisville Oncology Clinical Research ProgramLouisville, Kentucky  40202
Pharma ResouceEast Providence, Rhode Island  02915