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A Phase I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects With Advanced Solid Tumors


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

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Trial Information

A Phase I Clinical, Pharmacokinetic Study of ARQ 501 in Subjects With Advanced Solid Tumors

Inclusion Criteria


Inclusion Criteria

- Histologically or cytologically confirmed solid tumor that is metastatic,
unresectable or recurrent and for which standard curative or palliative measures do
not exist or are no longer effective.

- ECOG performance status greater than or equal to 1

- Life expectancy greater than three months

- Acceptable pretreatment clinical laboratory results

Exclusion Criteria

- Subjects who have had chemotherapy or radiotherapy within 4 weeks

- Subjects receiving any other investigational agents

- Subjects with known untreated brain metastases

- Subjects receiving hepatic enzyme-inducing antiseizure drugs ("EIASD")

- Subjects with uncontrolled intercurrent illnesses

- Pregnant women

Type of Study:

Interventional

Study Design:

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

Principal Investigator

Geoffrey I Shapiro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

ARQ 501-101

NCT ID:

NCT00075933

Start Date:

September 2003

Completion Date:

January 2007

Related Keywords:

  • Cancer

Name

Location

Mary Crowley Medical Research CenterDallas, Texas  75246
Dana Farber/Partners CancerCare IncBoston, Massachusetts  02115