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| Sponsor: | Sanofi-Aventis |
|---|---|
| Collaborator: |
BiPar Sciences |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00687765 |
Purpose
The phase I portion of study is designed to determine the Maximum Tolerated Dose (MTD) of BSI-201 with two clinically relevant dosing regimens of temozolomide (TMZ). Secondary objectives in the phase I trial include determining the PK of BSI-201 in malignant glioma patients and correlating BSI-201 PK with degree of PARP-1 inhibition. A safety run-in will confirm the safety of BSI-201 added to standard TMZ and radiation therapy and the phase II portion of the study will assess the efficacy and tolerability of the MTD dose of BSI-201 with daily TMZ and radiation therapy followed by adjuvant TMZ in patients with newly diagnosed GBM and assess overall survival as the primary outcome measure. Information on each phase of the study will be listed when each phase opens for enrollment.
Based on data generated by BiPar/Sanofi, 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 G2/M 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma |
Drug: bsi-201 plus temozolomide |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I/II Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma |
| Estimated Enrollment: | 100 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: bsi-201 plus temozolomide
BSI-201 given iv. 2x weekly, temozolomide given orally
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Phase I Criteria (Phase I Patients ONLY)
Exclusion Criteria:
Phase I Ineligibility Criteria (Phase I Patients ONLY)
Contacts and Locations| Contact: sanofi- aventis | Contact-Us@sanofi-aventis.com |
| United States, Alabama | |
| Research Site | Recruiting |
| Birmingham, Alabama, United States, 35294 | |
| United States, Florida | |
| Research Site | Recruiting |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| Research Site | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| United States, Maryland | |
| Research Site | Recruiting |
| Baltimore, Maryland, United States | |
| United States, Massachusetts | |
| Research Site | Recruiting |
| Boston, Massachusetts, United States, 92114 | |
| United States, Michigan | |
| Research Site | Recruiting |
| Detroit, Michigan, United States, 48202 | |
| United States, North Carolina | |
| Research Site | Recruiting |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Pennsylvania | |
| Research Site | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Study Director: | Clinical Sciences & Operations | Sanofi-Aventis |
More Information
| Responsible Party: | Trial Transparency Team, sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00687765 History of Changes |
| Obsolete Identifiers: | NCT00589576 |
| Other Study ID Numbers: | TCD11616, 20070104 |
| Study First Received: | May 28, 2008 |
| Last Updated: | June 13, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
patients with newly diagnosed glioblastoma |
|
Glioblastoma Glioma Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms, Nerve Tissue Temozolomide Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |