Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422682
Status:
COMPLETED
Last Update Posted:
2016-06-10
First Post:
2007-01-12
Brief Title:
A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase 1B Open-Label Dose Escalation Study Evaluating the Safety of BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT01130259
Has Expanded Access, NCT# Status:
NO_LONGER_AVAILABLE
Acronym:
None
Brief Summary:
The purpose of the study is to assess the safety and establish the maximum tolerated dose MTD of the combination of BSI-201 with chemotherapeutic regimens in adult subjects with histologically or cytologically documented advanced solid tumors
Based on data generated by BiParSanofi it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class The exact mechanism has not yet been fully elucidated however based on experiments on tumor cells performed in the laboratory iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX a marker of DNA damage in tumor cell lines induces cell cycle arrest in the G2M phase in tumor cell lines and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines Investigations into potential targets of iniparib and its metabolites are ongoing
Based on data generated by BiParSanofi it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class The exact mechanism has not yet been fully elucidated however based on experiments on tumor cells performed in the laboratory iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX a marker of DNA damage in tumor cell lines induces cell cycle arrest in the G2M phase in tumor cell lines and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines Investigations into potential targets of iniparib and its metabolites are ongoing
Detailed Description:
None
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 |
|---|---|---|---|
| 20060102 | OTHER | BiPar | None |