Completed
A Multicenter Phase I Clinical and Pharmacokinetic Study of Oral TAK-593 in Subjects With Nonhematologic Advanced Cancer
What is being tested
TAK-593
Drug
Who is being recruted
Over 18 Years
+20 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: January 2009
Summary
Principal SponsorMillennium Pharmaceuticals, Inc.
Last updated: January 27, 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
Principal SponsorMillennium Pharmaceuticals, Inc.
Last updated: January 27, 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
9 inclusion criteria required to participate
≥ 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.
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11 exclusion criteria prevent from participating
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
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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
Experimental3-6 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
CompletedOne Study Center