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

NCT00524524 | Completed Phase 1

• 1 other identifier: ARQ 501-109
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Solid Tumors

Keywords

solid tumors; biopsy

Outcome Measures

Primary Outcomes (1)

• To evaluate the pharmacodynamics of a panel of biomarkers following administration of ARQ 501

  Up to 30 hours after a single dose of ARQ 501

Secondary Outcomes (2)

• To further characterize the safety and tolerability of ARQ 501

• To assess anti-tumor activity of ARQ 501

Interventions

ARQ 501 DRUG

Weekly IV Infusion; 450 mg/m2

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.
• Patients must have histologically or cytologically confirmed advanced solid tumor(s).
• Measurable disease as defined by RECIST (see Section 9.0).
• Patients must have Karnofsky performance status (KPS) ≥ 70%.
• 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.
• Females of childbearing potential must have a negative serum pregnancy test within seven days prior to the administration of study drug.
• ≥ 18 years old.
• Hemoglobin ≥ 10 g/dL
• Absolute neutrophil count (ANC) ≥ 1.5 x 10 9/L (≥1,500/mm3).
• Platelets ≥ 100 x 10 9/L (≥ 100,000/mm3).
• Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 3.0 x ULN with metastatic liver disease.
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5.0 x ULN with metastatic liver disease.
• Creatinine ≤ 1.5 × ULN

You may not qualify if:

• Active, uncontrolled systemic infection considered opportunistic, life threatening or clinically significant at the time of treatment
• Received anticancer chemotherapy, immunotherapy, radiotherapy, surgery or investigational agents within four weeks of first infusion
• Symptomatic or untreated central nervous system (CNS) involvement
• 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 (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

beta-lapachone

Study Officials

• Geoffrey Shapiro, MD, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: September 3, 2007
• Study Start: August 1, 2007
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: October 19, 2011

Record last verified: 2011-10

Locations

US (1)