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

October 15, 2008
April 23, 2010
January 2009
January 2010   (final data collection date for primary outcome measure)
Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593 [ Time Frame: 18-24 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00773929 on ClinicalTrials.gov Archive Site
Response outcomes including objective response and clinical benefit response. [ Time Frame: 18-24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety Study of TAK-593 Given Orally in Subjects With Nonhematologic Advanced Cancer
A Multicenter Phase I Clinical and Pharmacokinetic Study of Oral TAK-593 in Subjects With Nonhematologic Advanced Cancer

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.

Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Solid Tumors
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

Experimental: 1
3-6 subjects each cohort. Escalate dose after safety evaluation of subjects in cohort
Intervention: Drug: TAK-593
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
April 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00773929
TAK-593_101
No
Clinical Research Monitor, Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Not Provided
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP