An Exploratory Biomarker Study of ARQ 501 in Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the response of several biomarkers in patients treated with ARQ 501. The results of the study may help the sponsor understand the effect of the study drug on these biomarkers and their respective role in cancer growth control.

• Phase: Phase 1
• 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:

1. Able to provide signed and dated informed consent prior to study-specific screening procedures.

2. Patients must have histologically or cytologically confirmed advanced solid tumor(s).

3. Measurable disease as defined by RECIST (see Section 9.0).

4. Patients must have Karnofsky performance status (KPS) ≥ 70%.

5. Male or female patients of child-producing potential must agree to contraception or avoidance of pregnancy measures during the study and for 30 days after the infusion of ARQ 501.

6. Females of childbearing potential must have a negative serum pregnancy test within seven days prior to the administration of study drug.

7. ≥ 18 years old.

8. Hemoglobin ≥ 10 g/dL

9. Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L (≥1,500/mm3).

10. Platelets ≥ 100 x 10 9/L (≥ 100,000/mm3).

11. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3.0 x ULN with metastatic liver disease.

12. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5.0 x ULN with metastatic liver disease.

13. Creatinine ≤ 1.5 × ULN

Exclusion Criteria:

1. Active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment

2. Received anticancer chemotherapy, immunotherapy, radiotherapy, surgery or investigational agents within four weeks of first infusion

3. Symptomatic or untreated central nervous system (CNS) involvement

4. Previous exposure to ARQ 501