Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma

Completed · Phase 2

Conditions studied: Cancer

In brief

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.

Key facts

Study ID

NCT00310518

Run by

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

People needed

30

Starts

2006-02-01

Expected to finish

2007-07-01

Last updated by the study team

2009-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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