CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 178 enrolled
Drug / intervention
NKTR-102 q14d +1 moredrug
Likely dose
Not stated in 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/NCT00806156
NCT00806156Phase 2Completed

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

Nektar Therapeutics·interventional·Posted Dec 10, 2008·Updated Jul 12, 2021

In Brief

A Phase 2 clinical trial evaluating NKTR-102 q14d and NKTR-102 q21d for Tumor and Ovarian Cancer. Completed, enrolled 178 participants across 20 sites in 3 countries.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 10, 2008
Enrollment StartOct 1, 2008
Primary CompletionOct 1, 2012
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 17.6 years ago

Interventions

NKTR-102 q14ddrug

NKTR-102 given on a q14 day schedule

NKTR-102 q21ddrug

NKTR-102 given on a q21 day schedule