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

NCT00773929 | Completed Phase 1

• 1 other identifier: TAK-593_101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593

  18-24 months

Secondary Outcomes (1)

• Response outcomes including objective response and clinical benefit response.

  18-24 months

Study Arms (1)

1

EXPERIMENTAL

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

Drug: TAK-593

Interventions

TAK-593 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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Millennium Pharmaceuticals, Inc.: lead

Study Sites (1)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Interventions

TAK 593

Study Officials

• Medical Monitor

  Millennium Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 15, 2008
• First Posted: October 16, 2008
• Study Start: January 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: April 1, 2010
• Last Updated: April 27, 2010

Record last verified: 2010-04

Locations

US (1)