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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00773929
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : April 27, 2010
Information provided by:
Millennium Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: TAK-593 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Phase I Clinical and Pharmacokinetic Study of Oral TAK-593 in Subjects With Nonhematologic Advanced Cancer
Study Start Date : January 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : April 2010

Arm Intervention/treatment
Experimental: 1
3-6 subjects each cohort. Escalate dose after safety evaluation of subjects in cohort
Drug: 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

Primary Outcome Measures :
  1. Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593 [ Time Frame: 18-24 months ]

Secondary Outcome Measures :
  1. Response outcomes including objective response and clinical benefit response. [ Time Frame: 18-24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00773929

United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.

Responsible Party: Clinical Research Monitor, Millennium Pharmaceuticals, Inc. Identifier: NCT00773929     History of Changes
Other Study ID Numbers: TAK-593_101
First Posted: October 16, 2008    Key Record Dates
Last Update Posted: April 27, 2010
Last Verified: April 2010