NCT00806156

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: Female
• 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 platinum-resistant ovarian cancer. Approximately 70 patients will be randomized 1:1 into one of two treatment arms. NKTR-102 will be administered at a dose level of 145 mg/m\^2 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. After the initial 70 patients have been enrolled, Arm B will enroll approximately 110 additional patients.

Conditions

• Tumor
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	NKTR-102 q14d	NKTR-102 given on a q14 day schedule
DRUG	NKTR-102 q21d	NKTR-102 given on a q21 day schedule

Timeline

• Start date: 2008-10-01
• Primary completion: 2012-10-01
• Completion: 2013-01-01
• First posted: 2008-12-10
• Last updated: 2021-07-12
• Results posted: 2021-06-14

Locations

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