ARQ 501 in Combination With Docetaxel in Patients With Cancer

A Phase Ib Safety and Pharmacokinetic Study of ARQ 501 in Combination With Docetaxol in Adult Patients With Locally Advanced or Metastatic Carcinoma

The purpose of this study is to determine the safety of ARQ 501 in combination with docetaxel in patients with advanced or metastatic cancer. In addition, the study is designed to observe the potential the combination of ARQ 501 and docetaxel have in treating cancer.

Study Overview

• Status: Completed
• Conditions: Carcinoma
• Intervention / Treatment: Drug: ARQ 501

Detailed Description

ARQ 501 has demonstrated activity in vitro against a wide range of solid tumors including lung, colorectal, breast, prostate, pancreatic, ovarian, and myeloma. To date, no histological cancer type studied appears inherently resistant to treatment with ARQ 501. In animal xenograft models of human tumors, ARQ 501 monotherapy has been effective in treating ovarian, colon, prostate, and breast cancer. When used in combination with taxane therapy, ARQ 501 has demonstrated efficacy in treating a variety of human cancers, including ovarian, breast, and colon.

This study is designed to explore whether the addition of ARQ 501 to a once every three week schedule of docetaxel is a safe and tolerable regimen. The study is designed to collect safety and pharmacokinetic data on the combination regimen and to measure the antitumor activity observed in patients.

• Study Type: Interventional
• Enrollment: 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Mary Crowley Medical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have a histologically or cytologically confirmed diagnosis of a locally advanced or metastatic carcinoma. (Patients may have either measurable or nonmeasurable disease.)
• Be ≥18 years old.
• Must not be eligible for therapy of higher curative potential.
• Have a Karnofsky Performance Status (KPS) of ≥70%.
• Have an estimated life expectancy of ≥12 weeks.
• Be male or non-pregnant, non-lactating female patients. Patients who are fertile agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, or cervical cap) to avoid pregnancy.
• Have a negative serum or urine pregnancy test within 7 days prior to the first dose of study drug (if patient is a female of childbearing potential).
• Sign a written informed consent document.
• Have adequate organ function as determined per protocol defined laboratory value

Exclusion Criteria:

• Have received previous treatment with ARQ 501.
• Have an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment.
• Are pregnant or lactating.
• Have a psychiatric disorder(s) that would interfere with consent, study participation, or follow-up.
• Have received any chemotherapy, immunotherapy, vaccines, monoclonal antibodies, major surgery, or irradiation, whether conventional or investigational, within 2 weeks of treatment in this study.
• Have not recovered from acute toxicity of all previous therapy prior to enrollment.
• Have any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
• Have symptomatic or untreated central nervous system (CNS) metastases.
• Have a known severe hypersensitivity to docetaxel or drugs formulated with polysorbate 80.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Determine the safety and tolerability of ARQ 501 in combination with docetaxel

Secondary Outcome Measures

Outcome Measure
Collect information regarding antitumor activity of ARQ 501 in combination with docetaxel

Collaborators and Investigators

• Sponsor: ArQule, Inc. (a wholly owned subsidiary of Merck Sharp and Dohme, a subsidiary of Merck & Co., Inc.)
• Investigators: Principal Investigator: C. Casey Cunningham, MD, Mary Crowley Medical Research Center

Study record dates

Study Major Dates

• Study Start: December 1, 2004
• Primary Completion (Actual): November 1, 2006
• Study Completion (Actual): November 1, 2006

Study Registration Dates

• First Submitted: December 10, 2004
• First Submitted That Met QC Criteria: December 9, 2004
• First Posted (Estimate): December 10, 2004

Study Record Updates

• Last Update Posted (Estimate): April 28, 2009
• Last Update Submitted That Met QC Criteria: April 27, 2009
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Keywords: cancer; solid tumor; advanced solid tumor
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Beta-lapachone
• Other Study ID Numbers: ARQ 501-111