A Multicenter Phase I Clinical and Pharmacokinetic Study of Oral TAK-593 in Subjects With Nonhematologic Advanced Cancer
TAK-593
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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