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ARQ 501

Phase 2

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

ARQ 501 development status

Highest phase Phase 2
Registered trials 6 across 1 sponsor since Jan 2004

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials7
Total Enrollment296

FDA Designations

No designations recorded

ARQ 501 clinical trials

ARQ 501 · 7 trials · 7 indications

Phase 2 3Phase 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
NCT00102700ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic CancerPancreatic Cancer
COMPLETED66 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
PHASE2COMPLETED
ARQ 501 in Combination With Gemcitabine in Subjects With Pancreatic Cancer
Pancreatic 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.
Document progression free survival after treatment with ARQ 501 and gemcitabine
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.
Document safety and efficacy of ARQ 501 in combination with gemcitabine
To further characterize the safety and tolerability of ARQ 501
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
ARQ 501DRUG -
ARQ 501 in combination with gemcitabineDRUG -
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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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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about ARQ 501

What is ARQ 501?

ARQ 501 is an investigational small molecule oncology drug developed by Merck & Company, Inc. (MRK). It has been studied in clinical trials for advanced solid tumors, carcinoma, head and neck neoplasms, and pancreatic cancer. It is also known as ARQ 501 in combination with gemcitabine. It is not an approved therapy.

What is ARQ 501 used for?

ARQ 501 has been studied in clinical trials for advanced solid tumors, cancer, carcinoma, head and neck neoplasms, and pancreatic cancer. Its clinical program includes a Phase 2 study in squamous cell carcinoma of the head and neck and a Phase 2 study in adult patients with leiomyosarcoma. It is investigational and not approved for any indication.

Who makes ARQ 501?

ARQ 501 is developed by Merck & Company, Inc., which trades under the ticker MRK. The company has sponsored the clinical trials evaluating ARQ 501 in advanced solid tumors, head and neck cancer, leiomyosarcoma, and other cancer types.

What phase is ARQ 501 in?

ARQ 501 is in Phase 1 development. Its clinical program includes Phase 1 studies and Phase 2 studies, all of which are completed. ARQ 501 is investigational and has not been approved by the FDA for any indication.

What clinical trials is ARQ 501 in?

ARQ 501 has been evaluated in completed clinical trials including NCT00622063, an extension study for previously treated patients; NCT00524524, an exploratory biomarker study in advanced solid tumors; NCT00358930, a study in squamous cell carcinoma of the head and neck; and NCT00310518, a safety and efficacy study in adult patients with leiomyosarcoma.