Head and Neck NeoplasmsPhase 2NCT00358930
A Study of ARQ 501 in Patients With Squamous Cell Carcinoma of the Head and Neck
A Phase 2 study testing ARQ 501 in people with Head and Neck Neoplasms and Carcinoma, Squamous Cell, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 9 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
- What is being tested?
- ARQ 501
- How many people
- 60 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2006to Aug 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide signed and dated informed consent document prior to study-specific screening procedures.
- Histologically or cytologically confirmed locally advanced, recurrent or metastatic SCCHN.
- Measurable disease per RECIST.
- ≥ 18 years old.
- Karnofsky performance status (KPS) ≥ 70%.
- 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.
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- Hemoglobin (Hgb) ≥ 10 g/dL.
- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L (≥ 1,500/mm³).
- Platelet count ≥ 100 x 10^9/L ( ≥ 100,000/mm³).
- 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.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 x ULN or less than or equal to 5.0 x ULN with metastatic liver disease.
- Creatinine less than or equal to 1.5 x ULN.
Who cannot join
- Primary tumor of nasopharyngeal origin.
- Eligible for curative surgery or radiotherapy.
- Received three or more systemic anticancer regimens.
- Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- Have received anticancer chemotherapy, immunotherapy, radiotherapy, or investigational agents within three weeks of first infusion.
- Surgery within two weeks of first infusion.
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- Have symptomatic or untreated central nervous system (CNS) involvement.
- Are pregnant or lactating.
- Previous exposure to ARQ 501.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
New York Oncology Hematology
Albany, New York, 12208
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Dana-Farber
Boston, Massachusetts, 02218
University of Chicago Medical Center
Chicago, Illinois, 60637
Mary Crowley Medical Research Center
Dallas, Texas, 75201
LA County Hospital
Los Angeles, California, 90033
Norris Comprehensive Cancer Center
Los Angeles, California, 90089-0178
University of South Alabama
Mobile, Alabama, 36693
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 2 Study of ARQ 501 in Patients With Locally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
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).
- Conditions
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
- Being tested
- ARQ 501
- Keywords
- squamous cell carcinoma of the head and neck
- Medical subject headings
- Head and Neck Neoplasms, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARQ 501Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Secondary outcomes (1)
Determine the progression-free survival (PFS) at six months for those patients treated with ARQ 501.To further characterize the safety ARQ 501.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00358930
- Sponsor's protocol ID
- ARQ 501-208
- Status last verified
- Apr 2009
- First submitted
- 28 Jul 2006
- Last updated
- 28 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of ARQ 501 in Patients With Locally Advanced, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT00358930
- Acronym / sponsor ID
- ARQ 501-208
- Conditions
- Head and Neck Neoplasms, Carcinoma, Squamous Cell
- Keywords
- squamous cell carcinoma of the head and neck
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)Industry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 1 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Able to provide signed and dated informed consent document prior to study-specific screening procedures.
- Histologically or cytologically confirmed locally advanced, recurrent or metastatic SCCHN.
- Measurable disease per RECIST.
- ≥ 18 years old.
- Karnofsky performance status (KPS) ≥ 70%.
Key exclusion criteria (9 listed)
- Primary tumor of nasopharyngeal origin.
- Eligible for curative surgery or radiotherapy.
- Received three or more systemic anticancer regimens.
- Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- Have received anticancer chemotherapy, immunotherapy, radiotherapy, or investigational agents within three weeks of first infusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARQ 501 | Drug | – |
Primary outcome
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.
1 secondary outcome
Determine the progression-free survival (PFS) at six months for those patients treated with ARQ 501.To further characterize the safety ARQ 501.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARQ 501 in people with Head and Neck Neoplasms and Carcinoma, Squamous Cell, run by ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2009.