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bsi-201 plus temozolomide

Phase 1

Glioblastoma | Small molecule | Oncology |Sanofi|Last Updated: Sep 14, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment126
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00687765Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant GliomaPHASE1 COMPLETED 126 — — Jul 1, 2008Jun 1, 2015Sep 14, 20228 United States
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Study Endpoints
Primary Endpoints
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
10 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
bsi-201 plus temozolomideDRUGBSI-201 given iv. 2x weekly, temozolomide given orally
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites8

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. A...

Countries:United States
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