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A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and Neck | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and Neck

A Phase 2 Study of ARQ 501 in Patients With Locally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT00358930•ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)

View on ClinicalTrials.gov

Summary

This is a Phase 2, multi-center, open label study of ARQ 501 in patients with locally advanced, recurrent or metastatic squamous cell cancer of the head and neck (SCCHN).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 status (KPS) ≥ 70%.
•6. Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last infusion of ARQ 501.
•7. Hemoglobin (Hgb) ≥ 10 g/dL.
•8. Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L (≥ 1,500/mm³).
•9. Platelet count ≥ 100 x 10\^9/L ( ≥ 100,000/mm³).
•10. Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) or less than or equal to 3.0 x ULN with metastatic liver disease.
+2 more criteria

Exclusion Criteria

•1. Primary tumor of nasopharyngeal origin.
•2. Eligible for curative surgery or radiotherapy.
•3. Received three or more systemic anticancer regimens.
•4. Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
•5. Have received anticancer chemotherapy, immunotherapy, radiotherapy, or investigational agents within three weeks of first infusion.
•6. Surgery within two weeks of first infusion.
•7. Have symptomatic or untreated central nervous system (CNS) involvement.
•8. Are pregnant or lactating.
•9. Previous exposure to ARQ 501.

Locations (9)

University of South Alabama

Mobile, Alabama, United States

LA County Hospital

Los Angeles, California, United States

Norris Comprehensive Cancer Center

Los Angeles, California, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Dana-Farber

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

New York Oncology Hematology

Albany, New York, United States

Mary Crowley Medical Research Center

Dallas, Texas, United States

Key Dates

Start Date

July 1, 2006

Primary Completion Date

August 1, 2007

Completion Date

August 1, 2007

Last Updated

April 28, 2009

Enrollment

Estimated participants

Conditions

Head and Neck NeoplasmsCarcinoma, Squamous Cell

Interventions

ARQ 501

DRUG

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

NCT04099290

Head and Neck NeoplasmCarcinoma, Squamous Cell

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RECRUITINGPHASE3

Head and Neck Cancer Study Project in the Geriatric Population

NCT06998069

Head and Neck Neoplasms

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RECRUITINGPHASE1

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 28, 2009Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria

Exclusion Criteria

Circulating Tumor DNA (ctDNA) in Locally Advanced Head and Neck Squamous Cell Carcinoma

Head and Neck Cancer Study Project in the Geriatric Population

Dose Finding Study of Zanzalintinib With Pembrolizumab and Cetuximab in Head and Neck SCC

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