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Patupilone

Phase 2

Hepatocellular Carcinoma | Small molecule | Oncology |Novartis AG|Last Updated: Feb 7, 2017

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 Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00273312Patupilone Activity in Advanced/Metastatic Hepatocellular CarcinomaPHASE2 COMPLETED 25Jan 1, 2006 -Feb 7, 20177 United States, Hong Kong +2
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Study Endpoints
Primary Endpoints
Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)
at screening and at completion of every 6 weeks prior to the next dose administration
Secondary Endpoints
Time to progression
at screening and at completion of every 6 weeks prior to the next dose administration
Overall survival
at screening and at completion of every 6 weeks prior to the next dose administration
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PatupiloneEXPERIMENTALwas administered at 10 mg/m2, as a single intravenous infusion over 20 minutes, once every 3 weeks
Interventions
NameTypeDescription
PatupiloneDRUGPatupilone was in dosage strength of 10 mg/4 mL as a clear, colorless concentrate for solution for injection in individual 10 mL glass vials
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion criteria: \- Hepatocellular carcinoma patients with at least 1 previously un-irradiated, measurable lesion without any systemic single agent or combination chemotherapy. Previous local therapy is allowed. Exclusion criteria: Additional protocol-defined inclusion/exclusion criteria apply...

Countries:United StatesHong KongSouth KoreaTaiwan
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