CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 179 enrolled
Drug / intervention
Cabazitaxel +1 moredrug
Likely dose
Cabazitaxel 25 milligramfrom 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/NCT01500720
NCT01500720Phase 2Completed
CompareCT.gov

Randomized Phase II Study of Cabazitaxel Versus Topotecan in Small Cell Lung Cancer Patients With Progressive Disease During or After a First Line Platinum Based Chemotherapy

Sanofi·interventional·Posted Dec 28, 2011·Updated Apr 13, 2015

In Brief

A Phase 2 clinical trial evaluating Cabazitaxel and Topotecan for Small Cell Lung Cancer. Completed, enrolled 179 participants across 58 sites in 16 countries.

Detailed Summary

Primary Objective: To demonstrate progression free survival (PFS) improvement for cabazitaxel compared to topotecan in participants with sensitive or resistant/refractory small cell lung cancer following a first line platinum based chemotherapy. Secondary Objectives: * To assess disease progression free rate at 12 weeks * To assess Response Rate (Response Evaluation Criteria in Solid Tumor \[RECIST\] 1.1) and duration of response * To assess Overall Survival (OS) * To assess the Safety (National Cancer Institute - Common Toxicity Criteria \[NCI-CTC\] version 4.03) * To assess the Health-Related Quality of Life (HRQoL)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSmall Cell Lung Cancer
CountriesBrazil, Canada, Chile, France, Germany, Greece, Hungary, Italy, Norway, Poland, Romania, Russia, South Korea, Spain, Ukraine, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 28, 2011
Enrollment StartMar 1, 2012
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 14.5 years ago

Interventions

Cabazitaxeldrug

Cabazitaxel 25 milligram per square meter (mg/m\^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.

Topotecandrug

Topotecan 1.5 mg/m\^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.