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ARQ 736

Phase 1

Solid Tumor | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: May 3, 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 Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01225536Dose Escalation Study of ARQ 736 in Adult Subjects With Advanced Solid Tumors Harboring BRAF and/or NRAS MutationsPHASE1 COMPLETED 24Oct 1, 2010Mar 1, 2013May 3, 20134 United States, Italy
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Study Endpoints
Primary Endpoints
Assess safety and tolerability of study drug in subjects with advanced solid tumors who have BRAF and/or NRAS mutations
Up to treatment discontinuation + 30 days with an estimated treatment duration of 24 weeks
Secondary Endpoints
Assess pharmacokinetic profile
During first cycle of treatment (28 days)
Assess pharmacodynamic activity
During first cycle of treatment (28 days) plus Day 1 of each consecutive cycle with an estimated treatment duration of 24 weeks
Determine preliminary evidence of activity
Up to treatment discontinuation with an estimated treatment duration of 24 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARQ 736EXPERIMENTAL -
Interventions
NameTypeDescription
ARQ 736DRUGSubjects in this study will receive ARQ 736 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 900 mg/day (first cohort) and escalate until the recommended Phase 2 dose or maximum tolerated dose is determined. Cycles will be repeated in four-week (28-day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Signed written informed consent granted prior to initiation of any study-specific procedures * Male or female subjects of ≥ 18 years of age * All subjects must be positive for a BRAF and/or NRAS mutation * Histologically or cytologically confirmed locally advanced, inoperable ...

Countries:United StatesItaly
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