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INIPARIB + irinotecan

Phase 2

Estrogen Receptor Negative (ER-Negative) Breast Cancer | Small molecule | Oncology |Sanofi|Last Updated: Mar 17, 2016

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 Enrollment44
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01173497A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain MetastasisPHASE2 COMPLETED 44Jul 1, 2010Jul 1, 2013Mar 17, 201613 United States
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Study Endpoints
Primary Endpoints
Efficacy
12 months

AS measured by intra or extra cranial time to progression (TTP)

Secondary Endpoints
Response Rate
12 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
INIPARIB, irinotecanEXPERIMENTAL -
Interventions
NameTypeDescription
INIPARIB + irinotecanDRUG21 day cycle
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Eligibility Criteria
Age Range21 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria - 1. Histologically-confirmed, ER negative, PR negative and Her2 negative adenocarcinoma of the breast with brain lesion on radiographic imaging. 2. ECOG Performance Status of 0-2. 3. Life expectancy of \>12 weeks. 4. No limit to prior therapies with last anti-cancer treatment ≥ ...

Countries:United States
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