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ridaforolimus

Phase 3

Metastatic Soft-Tissue Sarcomas | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Feb 13, 2015

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
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment711
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00538239Ridaforolimus in Treatment of Sarcoma-SUCCEED (Sarcoma Multi-Center Clinical Evaluation of the Efficacy of Ridaforolimus)(8669-011 AM6)PHASE3 COMPLETED 711Oct 1, 2007Dec 1, 2012Feb 13, 2015 -
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Study Endpoints
Primary Endpoints
Progression-free Survival
Up to 157 weeks after randomization
Secondary Endpoints
Overall survival: First Analysis
Up to 157 weeks after randomization
Best Target Lesion Response (RECIST)
Up to 157 weeks after randomization
Overall Survival: Updated Analysis as of 30 April 2011
Up to 184 weeks after randomization
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RidaforolimusEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
ridaforolimusDRUGFour 10 mg tablets taken by mouth for 5 days per week continuously
PlaceboDRUGFour 10 mg tablets taken by mouth for 5 days per week continuously
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Eligibility Criteria
Age Range13 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Confirmed diagnosis of metastatic soft-tissue or bone sarcoma * Ongoing complete response, partial response, or stable disease (RECIST) after a minimum of 4 cycles (and maximum of 12 months) of any one first, second, or third line of prior cytotoxic chemotherapy for metastatic...

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