Ignite Creation Date:
2024-05-05 @ 10:20 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01086254
Status:
COMPLETED
Last Update Posted:
2013-09-24
First Post:
2010-03-11
Brief Title:
SAR240550 in Combination With GemcitabineCisplatin in Non-small Cell Lung Cancer
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Randomized Phase 2 Study of GemcitabineCisplatin With or Without SAR240550 BSI-201 a PARP1 Inhibitor in Patients With Stage IV Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-09
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 assess the objective response rate ORR of Iniparib SAR240550 administered as a 60-min intravenous infusion twice weekly when combined to gemcitabinecisplatin chemotherapy regimen GCS as well as with the standard regimen of gemcitabinecisplatin GC in patients with stage IV non small cell lung cancer
Secondary objectives are
to assess the safety profiles of the study combination GCS and of the standard regimen GC
to assess the progression free survival and the overall survival in both arms
to assess the relationship between DNA repair pathway characteristics of tumors at baseline and clinical outcome of disease
to assess the effect of Iniparib on PAR level in peripheral blood mononuclear cells PBMC As of 10 September 2010 the collection of PBMC is temporarily discontinued
to assess the objective response rate ORR of Iniparib SAR240550 administered as a 60-min intravenous infusion twice weekly when combined to gemcitabinecisplatin chemotherapy regimen GCS as well as with the standard regimen of gemcitabinecisplatin GC in patients with stage IV non small cell lung cancer
Secondary objectives are
to assess the safety profiles of the study combination GCS and of the standard regimen GC
to assess the progression free survival and the overall survival in both arms
to assess the relationship between DNA repair pathway characteristics of tumors at baseline and clinical outcome of disease
to assess the effect of Iniparib on PAR level in peripheral blood mononuclear cells PBMC As of 10 September 2010 the collection of PBMC is temporarily discontinued
Detailed Description:
The duration of the study for a patient will include a period for inclusion of up to 3 weeks The patients may continue treatment up to a maximum of 6 cycles or until disease progression unacceptable toxicity or consent withdrawal followed by a minimum of 30-day follow-up after the last study treatment administration
Patients will be followed for at least 30 days after the last administration of study treatment for safety purpose In case of study treatment discontinuation without disease progression efficacy data will be collected every 6 weeks until disease progression death or end of study whatever comes first After disease progression the patient will be followed-up every 12 weeks 3 months for overall survival OS until death or end of study whatever comes first
The end of the study will be one year after the first dose of the last treated patient
Patients will be followed for at least 30 days after the last administration of study treatment for safety purpose In case of study treatment discontinuation without disease progression efficacy data will be collected every 6 weeks until disease progression death or end of study whatever comes first After disease progression the patient will be followed-up every 12 weeks 3 months for overall survival OS until death or end of study whatever comes first
The end of the study will be one year after the first dose of the last treated patient
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2009-017270-21 | EUDRACT_NUMBER | None | None |
| U1111-1116-5404 | OTHER | UTN | None |