ARQ 501 in Combination With Docetaxel in Patients With Cancer

NCT00099190 | Completed Phase 1

• 1 other identifier: ARQ 501-111
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Carcinoma

Keywords

cancer; solid tumor; advanced solid tumor

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

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:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Mary Crowley Medical Research Center

Dallas, Texas, 75246, United States

Location

MeSH Terms

Conditions

Carcinoma; Neoplasms

Interventions

beta-lapachone

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• C. Casey Cunningham, MD

  Mary Crowley Medical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 10, 2004
• First Posted: December 10, 2004
• Study Start: December 1, 2004
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: April 28, 2009

Record last verified: 2009-04

Locations

US (1)