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Metadata

Name
Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma
Repository
ClinicalTrials.gov
Identifier
clinicaltrials:NCT00687765
Description
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.
Data or Study Types
clinical trial
Source Organization
Unknown
Access Conditions
available
Year
2008
Access Hyperlink
https://clinicaltrials.gov/ct2/show/NCT00687765

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