NCT01457118

An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies

An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Nektar Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study objective of this open label, multicenter study is to provide access to NKTR-102 treatment to subjects previously enrolled in a NKTR-102 study who are without signs of disease progression since receiving NKTR-102. In addition the study will evaluate the safety of continued exposure to NKTR-102, observe disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy of NKTR-102 in subjects with advanced or metastatic solid tumors.

Conditions

• Malignant Solid Tumor

Interventions

Type	Name	Description
DRUG	NKTR-102 145 mg/m2	A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
DRUG	NKTR-102 120 mg/m2	A 90 minute IV infusion of 120 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
DRUG	NKTR-102 95 mg/m2	A 90 minute IV infusion of 95 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
DRUG	NKTR-102 50 mg/m2	A 90 minute IV infusion of 50 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.

Timeline

• Start date: 2011-10-01
• Primary completion: 2017-08-01
• Completion: 2017-11-01
• First posted: 2011-10-21
• Last updated: 2021-07-12
• Results posted: 2021-07-07

Locations

7 sites across 2 countries: United States, Belgium