Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by:
ArQule Identifier:
First received: March 31, 2006
Last updated: April 28, 2009
Last verified: April 2009

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 Intervention Phase
Drug: ARQ 501
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 2 Multi Center Open Label Study of ARQ 501 in Adult Patients With Recurrent, Persistent or Metastatic Leiomyosarcoma

Resource links provided by NLM:

Further study details as provided by ArQule:

Estimated Enrollment: 30
Study Start Date: February 2006
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

No publications provided Identifier: NCT00310518     History of Changes
Other Study ID Numbers: ARQ 501-221
Study First Received: March 31, 2006
Last Updated: April 28, 2009
Health Authority: United States: Food and Drug Administration processed this record on February 27, 2015