ARQ 501 in Combination With Docetaxel in Patients With Cancer

This study has been completed.
Sponsor:
Information provided by:
ArQule
ClinicalTrials.gov Identifier:
NCT00099190
First received: December 10, 2004
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Carcinoma
Drug: ARQ 501
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase Ib Safety and Pharmacokinetic Study of ARQ 501 in Combination With Docetaxol in Adult Patients With Locally Advanced or Metastatic Carcinoma

Resource links provided by NLM:


Further study details as provided by ArQule:

Primary Outcome Measures:
  • Determine the safety and tolerability of ARQ 501 in combination with docetaxel

Secondary Outcome Measures:
  • Collect information regarding antitumor activity of ARQ 501 in combination with docetaxel

Estimated Enrollment: 50
Study Start Date: December 2004
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099190

Locations
United States, Texas
Mary Crowley Medical Research Center
Dallas, Texas, United States, 75246
Sponsors and Collaborators
ArQule
Investigators
Principal Investigator: C. Casey Cunningham, MD Mary Crowley Medical Research Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00099190     History of Changes
Other Study ID Numbers: ARQ 501-111
Study First Received: December 10, 2004
Last Updated: April 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by ArQule:
cancer
solid tumor
advanced solid tumor

Additional relevant MeSH terms:
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Beta-lapachone
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents

ClinicalTrials.gov processed this record on September 16, 2014