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A Multicenter Phase I Clinical and Pharmacokinetic Study of Oral TAK-593 in Subjects With Nonhematologic Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors

Thank you

Trial Information

A Multicenter Phase I Clinical and Pharmacokinetic Study of Oral TAK-593 in Subjects With Nonhematologic Advanced Cancer


Inclusion Criteria:



- ≥ 18 years of age diagnosed with advanced solid tumor cancer that failed to respond
to standard therapies and where no other treatment options are available.

- No prior chemotherapy

- Able to understand and follow study requirements

- Subject or subject's legal representative signs a written, informed consent form
prior to beginning any study procedures.

- Women who are post-menopausal for at least 1 year before screening or surgically
sterile

- Women of childbearing potential agree to practice two effective methods of birth
control from the time of signing the informed consent form through 30 days after the
last dose of the study drug or agree to completely abstain from heterosexual
intercourse.

- Men who agree to practice an effective method of birth control for the entire study
treatment period and through 30 days after the last dose of study drug or completely
agree to abstain from heterosexual intercourse.

- Ability to swallow and retain oral medication

- Meet study specific laboratory test standards for bone marrow function, liver
function, blood pressure, and renal function.

Exclusion Criteria:

- Cancer has spread to the brain

- History of another cancer diagnosed or treated within the past 3 years.

- Severe cardiovascular issues including heart attack within the past 6 months,
unstable angina or arrhythmias that require treatments.

- Severe thyroid disease

- Unstable angina

- Arrhythmia issues

- History of bleeding issues

- Serious wounds, ulcers or bone fractures that do not heal

- Subject is pregnant or breast feeding

- Subject has illnesses or conditions that may affect their ability to participate in
the study

- Subject participated in another clinical study/post marketing clinical study within 4
weeks prior to the start of this trial.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593

Outcome Time Frame:

18-24 months

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

TAK-593_101

NCT ID:

NCT00773929

Start Date:

January 2009

Completion Date:

April 2010

Related Keywords:

  • Solid Tumors

Name

Location

Karmanos Cancer InstituteDetroit, Michigan  48201