Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma
NCT ID: NCT00310518
Last Updated: 2009-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2006-02-28
2007-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Interventions
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ARQ 501
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
INDUSTRY
Locations
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Premiere Oncology of Arizona
Scottsdale, Arizona, United States
City of Hope Medical Center
Duarte, California, United States
Premiere Oncology
Santa Monica, California, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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ARQ 501-221
Identifier Type: -
Identifier Source: org_study_id