An Open-Label, Multicenter, Extension Study of NKTR-102 in Subjects Previously Enrolled in NKTR-102 Studies
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Nektar Therapeutics
- Enrollment
- 27
- Locations
- 7
- Primary Endpoint
- Length of Exposure to NKTR-102
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
NKTR-102
Intervention: NKTR-102 145 mg/m2 (Drug)
NKTR-102
Intervention: NKTR-102 120 mg/m2 (Drug)
NKTR-102
Intervention: NKTR-102 95 mg/m2 (Drug)
NKTR-102
Intervention: NKTR-102 50 mg/m2 (Drug)
Outcomes
Primary Outcomes
Length of Exposure to NKTR-102
Time Frame: Screening, Every 21 day cycle of treatment and Quarterly Follow-up
To provide access to NKTR-102 to subjects who previously received NKTR-102 in a clinical trial and were without signs of disease progression since receiving NKTR-102.
Secondary Outcomes
- Adverse Events(Screening, Every 21 day cycle of treatment and Quarterly Follow-up)
- Efficacy of NKTR-102(Screening, Every 21 day cycle of treatment and Quarterly Follow-up)
- Disease Status(Screening, Every 21 day cycle of treatment and Quarterly Follow-up)