Safety Study of TAK-593 Given Orally in Subjects With Nonhematologic Advanced Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 3-6 subjects each cohort. Escalate dose after safety evaluation of subjects in cohort |
Drug: TAK-593
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
|
Outcome Measures
Primary Outcome Measures
- Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593 [18-24 months]
Secondary Outcome Measures
- Response outcomes including objective response and clinical benefit response. [18-24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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≥ 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.
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No prior chemotherapy
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Able to understand and follow study requirements
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Subject or subject's legal representative signs a written, informed consent form prior to beginning any study procedures.
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Women who are post-menopausal for at least 1 year before screening or surgically sterile
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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.
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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.
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Ability to swallow and retain oral medication
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Meet study specific laboratory test standards for bone marrow function, liver function, blood pressure, and renal function.
Exclusion Criteria:
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Cancer has spread to the brain
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History of another cancer diagnosed or treated within the past 3 years.
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Severe cardiovascular issues including heart attack within the past 6 months, unstable angina or arrhythmias that require treatments.
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Severe thyroid disease
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Unstable angina
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Arrhythmia issues
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History of bleeding issues
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Serious wounds, ulcers or bone fractures that do not heal
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Subject is pregnant or breast feeding
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Subject has illnesses or conditions that may affect their ability to participate in the study
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Subject participated in another clinical study/post marketing clinical study within 4 weeks prior to the start of this trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Karmanos Cancer Institute | Detroit | Michigan | United States | 48201 |
Sponsors and Collaborators
- Millennium Pharmaceuticals, Inc.
Investigators
- Study Director: Medical Monitor, Millennium Pharmaceuticals, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TAK-593_101