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ARQ 092

Phase 1

Solid Tumor | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Oct 23, 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 Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01473095Phase 1 Dose Escalation Study of ARQ 092 in Adult Subjects With Advanced Solid Tumors and Recurrent Malignant LymphomaPHASE1 COMPLETED 120Nov 1, 2011Aug 7, 2017Oct 23, 20177 United States
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Study Endpoints
Primary Endpoints
Assess the safety and tolerability of ARQ 092 in subjects with advanced solid tumors and recurrent malignant lymphoma by monitoring frequency and severity of adverse events
Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks
Secondary Endpoints
Assess the pharmacokinetic profile (Cmax, AUC, and half-life) of ARQ 092
During the first 29 days of treatment for each dose level
Assess pharmacodynamic activity
During the first 29 days of treatment
Determine preliminary evidence of activity as defined by RECIST v 1.1
Up to treatment discontinuation + 30 days with an estimated treatment duration of 4 to 16 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
ARQ 092DRUGSubjects in this study will receive ARQ 092 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 10 mg every other day (QOD) and will escalate until the MTD or RP2D 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 Sites7

Inclusion Criteria: 1. Men or women ≥18 years old 2. Histologically or cytologically documented, incurable, locally advanced or metastatic solid tumors or recurrent malignant lymphoma in subjects who failed standard therapy or for whom standard or curative therapy does not exist or is not tolerable...

Countries:United States
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