Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00773929
First received: October 15, 2008
Last updated: April 23, 2010
Last verified: April 2010
  Purpose

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 Intervention Phase
Solid Tumors
Drug: TAK-593
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593 [ Time Frame: 18-24 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response outcomes including objective response and clinical benefit response. [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2009
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773929

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

No publications provided

Responsible Party: Clinical Research Monitor, Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00773929     History of Changes
Other Study ID Numbers: TAK-593_101
Study First Received: October 15, 2008
Last Updated: April 23, 2010
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 25, 2014