Safety Study of TAK-593 Given Orally in Subjects With Nonhematologic Advanced Cancer

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

Conditions
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Solid Tumors

Intervention / Treatment
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* Drug: TAK-593


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>3-6 subjects each cohort. Escalate dose after safety evaluation of subjects in cohort | Drug: TAK-593<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593 |  | 18-24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response outcomes including objective response and clinical benefit response. |  | 18-24 months |