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

Cancer Clinical Trial

Official title:

A Phase 2 Multi Center Open Label Study of ARQ 501 in Adult Patients With Recurrent, Persistent or Metastatic Leiomyosarcoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310518
• Other study ID #: ARQ 501-221
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2006
• Last updated: April 28, 2009
• Start date: February 2006
• Est. completion date: July 2007

Study information

• Verified date: April 2009
• Source: ArQule
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer
• Leiomyosarcoma

Intervention

Drug:
• ARQ 501

Locations

Country	Name	City	State
United States	City of Hope Medical Center	Duarte	California
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Pennsylvania Oncology Hematology Associates	Philadelphia	Pennsylvania
United States	Premiere Oncology	Santa Monica	California
United States	Premiere Oncology of Arizona	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ArQule

Country where clinical trial is conducted

United States,