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Completed

NCT Number: NCT00773929

Safety Study of TAK-593 Given Orally 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.

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593

    Time frame: 18-24 months

Secondary outcomes

  1. Response outcomes including objective response and clinical benefit response.

    Time frame: 18-24 months

Sponsors and collaborators

Lead sponsor

Millennium Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Multicenter Phase I Clinical and Pharmacokinetic Study of Oral TAK-593 in Subjects With Nonhematologic Advanced Cancer

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 16, 2008
Registry last updated
Apr 27, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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