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

NCT00310518 | Completed Phase 2

• 1 other identifier: ARQ 501-221
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

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.

Conditions

Cancer

Interventions

ARQ 501 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA): lead

Study Sites (5)

Premiere Oncology of Arizona

Scottsdale, Arizona, 85260, United States

Location

City of Hope Medical Center

Duarte, California, 91010, United States

Location

Premiere Oncology

Santa Monica, California, 90404, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Pennsylvania Oncology Hematology Associates

Philadelphia, Pennsylvania, 19106, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

beta-lapachone

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 31, 2006
• First Posted: April 4, 2006
• Study Start: February 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: April 29, 2009

Record last verified: 2009-04

Locations

US (5)