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Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer

NCT01500720 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2015-04-13

Study results available
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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)

Conditions

Interventions

DRUG

Cabazitaxel

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.

DRUG

Topotecan

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States
  • Brazil
  • Canada
  • Chile
  • France
  • Germany
  • Greece
  • Hungary
  • Italy
  • Norway
  • Poland
  • Romania
  • Russia
  • South Korea
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01500720 on ClinicalTrials.gov