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

Millennium Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: TAK-593

Study type: Interventional

Funder types: Industry

Identifiers

NCT00773929

TAK-593_101

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

1

Experimental group

Description:

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

Treatment:

Drug: TAK-593