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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00773929
• Other study ID #: TAK-593_101
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2008
• Last updated: April 23, 2010
• Start date: January 2009
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

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

Locations

Country	Name	City	State
United States	Karmanos Cancer Institute	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593		18-24 months	Yes
Secondary	Response outcomes including objective response and clinical benefit response.		18-24 months	No