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A Phase 1 Dose Escalation Study of ARQ 171 in Adult Patients With Advanced Solid Tumors

Phase 1
18 Years
Not Enrolling

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Trial Information

A Phase 1 Dose Escalation Study of ARQ 171 in Adult Patients With Advanced Solid Tumors

Inclusion Criteria:

- Signed written informed consent must be obtained and documented prior to
study-specific screening procedures.

- A histologically or cytologically confirmed advanced solid tumor

- ≥ 18 years of age

- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors

- Karnofsky performance status ≥ 70%

- Male or female patients of child-producing potential must agree to use contraception
or avoidance of pregnancy measures during the study and for 30 days after

- Females of childbearing potential must have a negative serum pregnancy test.

- Laboratory results must meet study criteria.

Exclusion Criteria:

- Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents
within four weeks of first infusion

- Surgery within 4 weeks prior to first infusion

- Known untreated brain metastases

- Pregnant or breastfeeding

- Uncontrolled intercurrent illness, or uncontrolled infection or psychiatric
illness/social situations that would limit compliance with study requirements

- Other cancer within the last five years, with the exception of adequately treated
cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell
carcinoma of the skin

Type of Study:


Study Design:

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

Outcome Measure:

To determine the safety, tolerability and maximum tolerated dose (MTD) of ARQ 171


United States: Food and Drug Administration

Study ID:

ARQ 171-101



Start Date:

November 2006

Completion Date:

Related Keywords:

  • Cancer
  • Cancer
  • Solid Tumors
  • advanced solid tumors



Mary Crowley Medical Research Center Dallas, Texas  75246
Premiere Oncology Santa Monica, California  90404
Dana Farber/Harvard Cancer Center Boston, Massachusetts  02115