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ARQ 501

Phase 2

Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Feb 28, 2013

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 Trials3
Total Enrollment111
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00310518Safety and Efficacy Study of ARQ 501 in Adult Patients With LeiomyosarcomaPHASE2 COMPLETED 30Feb 1, 2006Jul 1, 2007Apr 29, 20095 United States
NCT00622063An Extension Study for Patients Previously Treated With ARQ 501PHASE1 COMPLETED 1Dec 1, 2006 -Feb 28, 20131 United States
NCT00075933ARQ 501 in Subjects With CancerPHASE1 COMPLETED 80Sep 1, 2003Jan 1, 2007Apr 28, 20092 United States
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Study Endpoints
Primary Endpoints
To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501
No time frame
Secondary Endpoints
To collect additional safety and tolerability information for ARQ 501 treatment
No time frame
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Interventions
NameTypeDescription
ARQ 501DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: * Able to provide signed and dated informed consent prior to study-specific screening procedures. * Histologically or cytologically confirmed leiomyosarcoma that is persistent, recurrent or metastatic. * Measurable disease as defined by RECIST. * Karnofsky performance status \>=...

Countries:United States
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