CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 85 enrolled
Drug / intervention
Cabazitaxeldrug
Likely dose
Cabazitaxel 20mgfrom 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/NCT01757171
NCT01757171Phase 2Completed

An Open-Labeled, Multicenter Phase II Study of Cabazitaxel in Refractory Metastatic Gastric or Gastroesophageal Adenocarcinoma

Weill Medical College of Cornell University·interventional·Posted Dec 28, 2012·Updated Apr 3, 2018

In Brief

A Phase 2 clinical trial evaluating Cabazitaxel for Gastric Adenocarcinoma and 2 related conditions. Completed, enrolled 85 participants across 5 sites.

Detailed Summary

Cabazitaxel will be administered 20 mg/m2 IV over 1 hour every 3 weeks, as is the standard administration dose and schedule. This application is a non-labeled indication for cabazitaxel and will inform future drug development in gastroesophageal malignancies, where docetaxel remains an approved first line agent, but is not routinely used due to excessive toxicity and marginal efficacy. At the conclusion of this study, we hope to demonstrate activity of single agent cabazitaxel in refractory gastric cancer, with preferential activity in one or more gastric cancer subtypes

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsSanofi

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 28, 2012
Enrollment StartDec 1, 2012
Primary CompletionJul 1, 2016
Study CompletionJun 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.5 years ago

Interventions

Cabazitaxeldrug

20mg IV over 1 hour every 3 weeks