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ARQ 621

Phase 1

Metastatic Solid Tumors, Refractory/Relapsed Hematologic Malignancies | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Oct 19, 2011

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 Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00825487Dose Escalation Study of ARQ 621 in Adult Patients With Metastatic Solid Tumors and Hematologic MalignanciesPHASE1 COMPLETED 50Aug 1, 2009Sep 1, 2011Oct 19, 20114 United States
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Study Endpoints
Primary Endpoints
To determine the safety, tolerability and recommended Phase 2 dose (RP2D) of ARQ 621 administered intravenously.
24 months estimated
Secondary Endpoints
To determine the pharmacokinetic profile of ARQ 621.
24 months estimated
To determine the pharmacodynamic profile (incl. biomarkers) of ARQ 621.
24 months estimated
To assess the preliminary anti-tumor activity of ARQ 621.
24 months estimated
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARQ 621 treatmentEXPERIMENTAL -
Interventions
NameTypeDescription
ARQ 621DRUGTreatment will be initiated at a dose level of 10 mg/m\^2 IV infusion for an hour once weekly in 4-week (28 day) consecutive and continuous cycles. ARQ 621 should be infused IV over two hours at doses 200 mg/m\^2 and higher (cohort 8 and above).
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insuran...

Countries:United States
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