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PARP inhibitor BMN-673

Phase 1

Metastatic Cancer | Small molecule | Oncology |BioMarin Pharmaceutical Inc.|Last Updated: Sep 26, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02049593PARP Inhibitor BMN-673 and Temozolomide or Irinotecan Hydrochloride in Treating Patients With Locally Advanced or Metastatic Solid TumorsPHASE1 COMPLETED 44Jun 12, 2014Oct 7, 2019Sep 26, 20221 United States
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Study Endpoints
Primary Endpoints
Dose Limiting Toxicity graded using the NCI CTCAE v. 4.03
Up to 28 days
Secondary Endpoints
Incidence of adverse events graded by NCI CTCAE v. 4.03
Up to 12 months
Levels of PARP inhibitory BMN 673
Baseline, at 30 and 60 minutes, at 1.5, 2, 3, 4, 6, and 8 hours of day 1 of courses 1 and 2
levels of temozolomide
Baseline, at 30 and 60 minutes, at 1.5, 2, 3, 4, 6, and 8 hours of day 1 of courses 1 and 2
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A (PARP inhibitor BMN-673, temozolomide)EXPERIMENTALPatients receive PARP inhibitor BMN-673 PO QD on days 1-28 and temozolomide PO daily on days1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Arm B (PARP inhibitor BMN-673, irinotecan hydrochloride)EXPERIMENTALPatients receive PARP inhibitor BNM-673 as in Arm A and irinotecan hydrochloride IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions
NameTypeDescription
PARP inhibitor BMN-673DRUGGiven PO
temozolomideDRUGGiven PO
irinotecan hydrochlorideDRUGGiven IV
pharmacological studyOTHERCorrelative studies
laboratory biomarker analysisOTHERCorrelative studies
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Histologically or cytologically documented, unresectable, locally advanced or metastatic solid tumor for which no standard therapy is recognized or for which standard therapy has failed * Measurable disease as defined by Response Evaluation Criteria in Solid Tumors version 1.1...

Countries:United States
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