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

Phase 1
18 Years
Not Enrolling

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Trial Information

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

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.

Inclusion Criteria:

- Have a histologically or cytologically confirmed diagnosis of a locally advanced or
metastatic carcinoma. (Patients may have either measurable or nonmeasurable

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

C. Casey Cunningham, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mary Crowley Medical Research Center


United States: Food and Drug Administration

Study ID:

ARQ 501-111



Start Date:

December 2004

Completion Date:

November 2006

Related Keywords:

  • Carcinoma
  • cancer
  • solid tumor
  • advanced solid tumor
  • Carcinoma



Mary Crowley Medical Research Center Dallas, Texas  75246