Safety Study of TAK-593 Given Orally in Subjects With Nonhematologic Advanced Cancer

NCT ID: NCT00773929

Last Updated: 2010-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2010-04-30

Brief Summary

The purpose of this study is to determine the safety and toxicity profile of TAK-593 and determine the maximum tolerated dose of TAK-593.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

3-6 subjects each cohort. Escalate dose after safety evaluation of subjects in cohort

Group Type: EXPERIMENTAL

TAK-593

Intervention Type: DRUG

Tablets of TAK-593 investigational drug for oral administration, tablets in 2 strengths: 1 mg and 4 mg tablets.

Administration will initially be 4 mg, once a day and transition to 2 mg BID schedule dependant on safety

Interventions

TAK-593

Tablets of TAK-593 investigational drug for oral administration, tablets in 2 strengths: 1 mg and 4 mg tablets.

Administration will initially be 4 mg, once a day and transition to 2 mg BID schedule dependant on safety

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Millennium Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Millennium Pharmaceuticals, Inc.

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Millennium Pharmaceuticals, Inc.

Locations

Karmanos Cancer Institute

Detroit, Michigan, United States

Countries

United States

Other Identifiers

TAK-593_101

Identifier Type: -

Identifier Source: org_study_id