Completed

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

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What is being tested

TAK-593

Drug
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: January 2009
See protocol details

Summary

Principal SponsorMillennium Pharmaceuticals, Inc.
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2009

Actual date on which the first participant was enrolled.

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.

Official TitleA Multicenter Phase I Clinical and Pharmacokinetic Study of Oral TAK-593 in Subjects With Nonhematologic Advanced Cancer 
NCT00773929
Principal SponsorMillennium Pharmaceuticals, Inc.
Last updated: January 18, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Karmanos Cancer Institute

Detroit, United StatesSee the location
CompletedOne Study Center