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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ArQule; ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
• Treatments: Beta-lapachone

Criteria

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.