NCT00802945

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tumor
• Breast Cancer

Interventions

Type	Name	Description
DRUG	NKTR-102	NKTR-102 given on a q14 day schedule
DRUG	NKTR-102	NKTR-102 given on a q21 day schedule

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-10-01
• Completion: 2012-01-01
• First posted: 2008-12-05
• Last updated: 2018-07-09
• Results posted: 2018-07-09

Locations

19 sites across 3 countries: United States, Belgium, United Kingdom