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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00310518
Recruitment Status : Completed
First Posted : April 4, 2006
Last Update Posted : April 29, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Cancer Drug: ARQ 501 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Phase 2 Multi Center Open Label Study of ARQ 501 in Adult Patients With Recurrent, Persistent or Metastatic Leiomyosarcoma
Study Start Date : February 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00310518

United States, Arizona
Premiere Oncology of Arizona
Scottsdale, Arizona, United States, 85260
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
Premiere Oncology
Santa Monica, California, United States, 90404
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Pennsylvania Oncology Hematology Associates
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
ArQule Identifier: NCT00310518     History of Changes
Other Study ID Numbers: ARQ 501-221
First Posted: April 4, 2006    Key Record Dates
Last Update Posted: April 29, 2009
Last Verified: April 2009

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents