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Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma
This study is currently recruiting participants.
Verified by BiPar Sciences, July 2009
First Received: May 28, 2008   Last Updated: July 23, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by BiPar Sciences:

Primary Outcome Measures:
  • To determine the Maximum Tolerated Dose (MTD) of BSI-201, administered as an IV infusion in patients with newly diagnosed malignant glioma when given with temozolomide (TMZ) after the completion of standard radiation therapy and concomitant TMZ [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

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
Criteria

Inclusion Criteria:

  1. Patients must be at least 18 years of age.
  2. Patients must have a Karnofsky performance status > 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
  3. Patients must have the following hematologic, renal and liver function (i.e. Absolute neutrophil count > 1500/mm3, Platelets > 100,000/mm3, creatinine < 1.7 mg/dl, total bilirubin ≤ 1.5 mg/dl, transaminases < 4 times above the upper limits of the institutional normal.
  4. Patients must be able to provide written informed consent.
  5. Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Women of childbearing potential must have a negative pregnancy test. The anti-proliferative activity of this experimental drug as well as the standard drug (temozolomide) may be harmful to the developing fetus or nursing infant.
  6. Patients must have a Mini Mental Status Exam score of > 15.
  7. Patients must have tumor tissue form completed and signed by a pathologist. See section 9.6 for details.

Phase I Criteria (Phase I Patients ONLY)

  1. Patients must have histologically proven supratentorial malignant glioma (anaplastic astrocytoma, anaplastic oliogodendroglioma or glioblastoma multiforme).
  2. Patients must have received at least 80% of planned temozolomide and radiation therapy with no grade 3 or grade 4 toxicity attributed to the temozolomide.
  3. Patients must have received planned treatment with radiation therapy and concomitant temozolomide at least 28 days but no more than 49 days prior to starting treatment on this study.
  4. Patients must have Gadolinium MRI or contrast CT scan within 28 days of starting treatment.

Exclusion Criteria:

  1. Patients with serious concurrent infection or medical illness, which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety.
  2. Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant.
  3. Patients receiving concurrent therapy for their tumor (i.e. chemotherapeutics or investigational agents).
  4. Patients with a concurrent or prior malignancy are ineligible unless they are patients with curatively treated carcinoma-in-situ or basal cell carcinoma of the skin. Patients who have been free of disease (any prior malignancy) for greater than five years are eligible for this study.
  5. Patients cannot be receiving cytochrome P450-inducing anticonvulsants (EIAEDs; e.g., phenytoin, carbamazepine, phenobarbital, primidone, oxcarbazepine) and must not have taken them for at least 10 days.

Phase I Ineligibility Criteria (Phase I Patients ONLY)

  1. Patients who have had repeat craniotomy for tumor therapy after receiving RT and TMZ treatment.
  2. Patients who received other chemotherapeutics or investigational agents in addition to their radiation therapy and concomitant temozolomide treatment. Patients who have received Gliadel wafers are eligible for this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00687765

Contacts
Contact: bipar sciences 650-228-1880

Locations
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
Sponsors and Collaborators
BiPar Sciences
  More Information

No publications provided

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

Keywords provided by BiPar Sciences:
patients with newly diagnosed glioblastoma

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 25, 2009