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

This study has been completed.

Sponsor:

Information provided by:

ArQule

ClinicalTrials.gov Identifier:

NCT00310518

First received: March 31, 2006

Last updated: April 28, 2009

Last verified: April 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	March 31, 2006
Last Updated Date	April 28, 2009
Start Date ^ICMJE	February 2006
Primary Completion Date	July 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00310518 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma
Official Title ^ICMJE	A Phase 2 Multi Center Open Label Study of ARQ 501 in Adult Patients With Recurrent, Persistent or Metastatic Leiomyosarcoma
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Cancer
Intervention ^ICMJE	Drug: ARQ 501
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date	July 2007
Primary Completion Date	July 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00310518
Other Study ID Numbers ^ICMJE	ARQ 501-221
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	ArQule
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ArQule
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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