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

Sponsor
ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.) (Industry)
Overall Status
Completed
CT.gov ID
NCT00310518
Collaborator
(none)
30
Enrollment
5
Locations
16.9
Duration (Months)
6
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: ARQ 501
 Phase 2

Study Design

Study Type:
Interventional
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 :
Feb 1, 2006
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Jul 1, 2007

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Premiere Oncology of Arizona Scottsdale Arizona United States 85260
    2 City of Hope Medical Center Duarte California United States 91010
    3 Premiere Oncology Santa Monica California United States 90404
    4 Memorial Sloan-Kettering Cancer Center New York New York United States 10021
    5 Pennsylvania Oncology Hematology Associates Philadelphia Pennsylvania United States 19106

    Sponsors and Collaborators

    • ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00310518
    Other Study ID Numbers:
    • ARQ 501-221
    First Posted:
    Apr 4, 2006
    Last Update Posted:
    Apr 29, 2009
    Last Verified:
    Apr 1, 2009
    Additional relevant MeSH terms:
    Leiomyosarcoma
    Beta-lapachone

    Study Results

    No Results Posted as of Apr 29, 2009