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BSI-201

Phase 2

Uterine Carcinosarcoma | Small molecule | Oncology |Sanofi|Last Updated: Aug 7, 2012

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 Enrollment22
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00687687Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine CarcinosarcomaPHASE2 COMPLETED 22May 1, 2008Dec 1, 2011Aug 7, 201240 United States
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Study Endpoints
Primary Endpoints
Clinical response rate
6 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Pacitaxel/Carboplatin/IniparibEXPERIMENTALParticipants will be administered pacitaxel, carboplatin and BSI-201 (Iniparib) in 21 day treatment cycles. Treatment will continue until disease progression or adverse effects prohibit further therapy.
Interventions
NameTypeDescription
paclitaxelDRUGPaclitaxel will be administered IV over 3 hours on Day 1 every 21 days.
carboplatinDRUGCarboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days.
BSI-201 (Iniparib)DRUGBSI-201 will be administered IV over one hour twice weekly beginning on day 1 (doses of BSI-201 must be separated by at least 2 days).
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * Patients must have advanced (stage III or IV), persistent or recurrent uterine carcinosarcoma with documented disease progression. Histologic confirmation of the original primary tumor is required. * All patients must have measurable disease. Measurable disease is defined as a...

Countries:United States
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