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ARQ 501

Phase 2

Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Feb 28, 2013

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials3
Total Enrollment111

FDA Designations

No designations recorded

Clinical trial landscape

ARQ 501 · 6 trials · 5 indications

Phase 2 2Phase 1 4
NCT00358930A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and NeckHead and Neck Neoplasms
COMPLETED60 Analytics
NCT00310518Safety and Efficacy Study of ARQ 501 in Adult Patients With LeiomyosarcomaCancer
COMPLETED30 Analytics
PHASE2COMPLETED
A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and Neck
Head and Neck NeoplasmsUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Assess the overall response rate (ORR) of patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) treated with ARQ 501.
To evaluate the pharmacodynamics of a panel of biomarkers following administration of ARQ 501
Up to 30 hours after a single dose of ARQ 501
To provide ongoing treatment with ARQ 501 for patients who have benefited from prior treatment with ARQ 501
No time frame
Determine the safety and tolerability of ARQ 501 in combination with docetaxel

Secondary Endpoints

Determine the progression-free survival (PFS) at six months for those patients treated with ARQ 501.To further characterize the safety ARQ 501.
To further characterize the safety and tolerability of ARQ 501
To assess anti-tumor activity of ARQ 501
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
ARQ 501DRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. Able to provide signed and dated informed consent document prior to study-specific screening procedures. 2. Histologically or cytologically confirmed locally advanced, recurrent or metastatic SCCHN. 3. Measurable disease per RECIST. 4. ≥ 18 years old. 5. Karnofsky performance...

Countries:United States
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Frequently asked questions about ARQ 501

What is ARQ 501 used for?

ARQ 501 is an investigational small molecule being studied for the treatment of cancer, including head and neck neoplasms, advanced solid tumors, and carcinoma. It has been evaluated in clinical trials for these oncology indications, though it remains in clinical development and is not approved for any use.

Who is developing ARQ 501?

ARQ 501 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is an oncology small molecule that has been studied in early-phase clinical trials for various cancer types.

What phase is ARQ 501 in?

ARQ 501 has been studied in Phase 1 and Phase 2 clinical trials. All three completed trials include two Phase 1 studies and one Phase 2 study. The drug is investigational and has not received FDA approval, as it is still in clinical development.

What clinical trials has ARQ 501 been in?

ARQ 501 has been studied in three completed clinical trials. NCT00075933 was a Phase 1 study in subjects with cancer enrolling 80 participants. NCT00310518 was a Phase 2 study in adult patients with leiomyosarcoma enrolling 30 participants. NCT00524524 was a Phase 1 exploratory biomarker study in patients with advanced solid tumors enrolling 9 participants.

Is ARQ 501 the same as any other drug?

ARQ 501 is the name used in clinical trials for this investigational oncology small molecule. No alternative names have been reported for this drug in the trial records, so it is not known to be the same as any other marketed or investigational agent.