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| Sponsor: | BiPar Sciences |
|---|---|
| Information provided by: | BiPar Sciences |
| ClinicalTrials.gov Identifier: | NCT00687765 |
Purpose
The phase I portion of study is designed to determine the MTD of BSI-201 with two clinically relevant dosing regimens of 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma |
Drug: bsi-201 plus temozolomide |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| 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: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
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: bipar sciences | 650-228-1880 |
| 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 | |
More Information
| Responsible Party: | bipar sciences ( vp clinical development ) |
| Study ID Numbers: | 20070104 |
| Study First Received: | May 28, 2008 |
| Last Updated: | July 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00687765 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
patients with newly diagnosed glioblastoma |
|
Glioblastoma Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Astrocytoma Antineoplastic Agents Neoplasms, Nerve Tissue Temozolomide Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Antineoplastic Agents, Alkylating Neoplasms, Neuroepithelial Alkylating Agents Neoplasms, Glandular and Epithelial |