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ARQ 736

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

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 9 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 solid tumors. It is in Phase 1 clinical development for advanced solid tumors that harbor BRAF and/or NRAS mutations. The drug is being developed by Merck & Company, Inc. (MRK).

What does ARQ 736 target?

ARQ 736 is being studied in solid tumors that harbor BRAF and/or NRAS mutations. The clinical trial for ARQ 736 specifically enrolls adult subjects with advanced solid tumors harboring these mutations, indicating that the drug is being evaluated in a mutation-selected patient population.

Who is developing ARQ 736?

ARQ 736 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The drug is currently in Phase 1 clinical development for the treatment of solid tumors.

What phase is ARQ 736 in?

ARQ 736 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 dose escalation study of ARQ 736 in adult subjects with advanced solid tumors has been completed.

What clinical trials is ARQ 736 in?

ARQ 736 has one completed clinical trial, NCT01225536, titled "Dose Escalation Study of ARQ 736 in Adult Subjects With Advanced Solid Tumors Harboring BRAF and/or NRAS Mutations." This Phase 1 study enrolled 24 participants and was conducted in the United States and Italy.

Is ARQ 736 the same as any other drug?

ARQ 736 is the drug name used in clinical development. No alternative names for ARQ 736 have been disclosed in the available clinical trial information.