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

March 31, 2006
April 28, 2009
February 2006
July 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00310518 on ClinicalTrials.gov Archive Site
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Safety and Efficacy Study of ARQ 501 in Adult Patients With Leiomyosarcoma
A Phase 2 Multi Center Open Label Study of ARQ 501 in Adult Patients With Recurrent, Persistent or Metastatic Leiomyosarcoma

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.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Cancer
Drug: ARQ 501
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2007
July 2007   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00310518
ARQ 501-221
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ArQule
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Not Provided
ArQule
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP