- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00310518
Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma
April 28, 2009 updated by: ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
A Phase 2 Multi Center Open Label Study of ARQ 501 in Adult Patients With Recurrent, Persistent or Metastatic Leiomyosarcoma
The purpose of this study is to assess the overall response rate (ORR) of persistent, recurrent or metastatic leiomyosarcoma in patients treated with ARQ 501.
Study Overview
Study Type
Interventional
Enrollment
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85260
- Premiere Oncology of Arizona
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California
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Duarte, California, United States, 91010
- City of Hope Medical Center
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Santa Monica, California, United States, 90404
- Premiere Oncology
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New York
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New York, New York, United States, 10021
- Memorial Sloan-Kettering Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19106
- Pennsylvania Oncology Hematology Associates
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Able to provide signed and dated informed consent prior to study-specific screening procedures.
- Histologically or cytologically confirmed leiomyosarcoma that is persistent, recurrent or metastatic.
- Measurable disease as defined by RECIST.
- Karnofsky performance status >= 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.
- 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 less than or equal to 5.0 ULN with metastatic liver disease.
- Creatinine less than or equal to 1.5 x ULN.
Exclusion Criteria:
- Received three or more prior anticancer chemotherapy regimens.
- Have active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment.
- Have received anticancer chemotherapy, immunotherapy, radiotherapy, surgery or investigational agents within four weeks of first infusion.
- Have symptomatic or untreated central nervous system (CNS) involvement.
- Are pregnant or breastfeeding.
- Previous exposure to ARQ 501.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (Actual)
July 1, 2007
Study Completion (Actual)
July 1, 2007
Study Registration Dates
First Submitted
March 31, 2006
First Submitted That Met QC Criteria
March 31, 2006
First Posted (Estimate)
April 4, 2006
Study Record Updates
Last Update Posted (Estimate)
April 29, 2009
Last Update Submitted That Met QC Criteria
April 28, 2009
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Sarcoma
- Neoplasms, Muscle Tissue
- Leiomyosarcoma
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Beta-lapachone
Other Study ID Numbers
- ARQ 501-221
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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