Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma
Phase 2
Completed
- Conditions
- Cancer
- Registration Number
- NCT00310518
- Lead Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (5)
Premiere Oncology of Arizona
🇺🇸Scottsdale, Arizona, United States
City of Hope Medical Center
🇺🇸Duarte, California, United States
Premiere Oncology
🇺🇸Santa Monica, California, United States
Pennsylvania Oncology Hematology Associates
🇺🇸Philadelphia, Pennsylvania, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States