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

Small Cell Lung Cancer Clinical Trial

Official title:
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

Clinical Trial 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)

Clinical Trial Description

Participants are to be treated until progressive disease, unacceptable toxicity or refusal for further study treatment.

All participants are to be followed for disease progression documentation and for participant status until the study cut-off date. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01500720
Study type Interventional
Source Sanofi
Contact
Status Completed
Phase Phase 2
Start date March 2012
Completion date April 2014
View Details
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