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ARQ 736

Phase 1

Solid Tumor | Small molecule | Oncology |Merck & Company, Inc.|Trials Updated: May 3, 2013

ARQ 736 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2010

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

ARQ 736 clinical trials

ARQ 736 · 1 trial · 1 indication

Phase 1 1
NCT01225536Dose Escalation Study of ARQ 736 in Adult Subjects With Advanced Solid Tumors Harboring BRAF and/or NRAS MutationsSolid Tumor
COMPLETED24 Analytics
PHASE1COMPLETED
Dose Escalation Study of ARQ 736 in Adult Subjects With Advanced Solid Tumors Harboring BRAF and/or NRAS Mutations
Solid TumorUnlock trial analytics

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 to 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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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumor")

Frequently asked questions about ARQ 736

What is ARQ 736 used for?

ARQ 736 is an investigational small molecule being studied for the treatment of advanced solid tumors that harbor BRAF and/or NRAS mutations. It is not approved for any indication and remains in clinical development. The only reported trial enrolled adults with these biomarker-selected tumors.

Who is developing ARQ 736?

ARQ 736 is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company sponsored the Phase 1 dose escalation study of ARQ 736 in patients with advanced solid tumors harboring BRAF and/or NRAS mutations.

What phase is ARQ 736 in?

ARQ 736 is in Phase 1 clinical development. It has completed one Phase 1 dose escalation trial in adult subjects with advanced solid tumors harboring BRAF and/or NRAS mutations. No later-phase trials have been reported, and the drug is not approved.

What clinical trials is ARQ 736 in?

ARQ 736 has been evaluated in one completed Phase 1 trial, NCT01225536, titled Dose Escalation Study of ARQ 736 in Adult Subjects With Advanced Solid Tumors Harboring BRAF and/or NRAS Mutations. The study enrolled 24 adults across sites in the United States and Italy.

Is ARQ 736 FDA approved?

No, ARQ 736 is not FDA approved. It is an investigational small molecule that has completed a single Phase 1 dose escalation study in advanced solid tumors with BRAF and/or NRAS mutations. It remains in clinical development and is not available as a marketed therapy.