Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-03 @ 6:46 PM
Study NCT ID:
NCT01500720
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2011-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cabazitaxel Compared to Topotecan for the Treatment of Small Cell Lung Cancer
Sponsor:
Sanofi
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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)
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)
Detailed 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.
All participants are to be followed for disease progression documentation and for participant status until the study cut-off date.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: