CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
NKTR-102 145 mg/m2 +3 moredrug
Likely dose
NKTR-102 145 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01457118
NCT01457118Phase 2Completed

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

Nektar Therapeutics·interventional·Posted Oct 21, 2011·Updated Jul 12, 2021

In Brief

A Phase 2 clinical trial evaluating NKTR-102 145 mg/m2, NKTR-102 120 mg/m2, and 2 other interventions for Malignant Solid Tumor. Completed, enrolled 27 participants across 7 sites in 2 countries.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 21, 2011
Enrollment StartOct 1, 2011
Primary CompletionAug 1, 2017
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 14.7 years ago

Interventions

NKTR-102 145 mg/m2drug

A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.

NKTR-102 120 mg/m2drug

A 90 minute IV infusion of 120 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.

NKTR-102 95 mg/m2drug

A 90 minute IV infusion of 95 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.

NKTR-102 50 mg/m2drug

A 90 minute IV infusion of 50 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.