Safety Study of TAK-593 Given Orally in Subjects With Non... | NCT00773929

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

NCT00773929

Sponsor

Millennium Pharmaceuticals, Inc.

Status

Completed

Last Update Posted

Apr 27, 2010Estimated

Enrollment

60Estimated

Phase

Phase 1

Conditions

Solid Tumors

Interventions

TAK-593

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jan 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Oct 15, 2008

First Submission Date that Met QC Criteria

Oct 15, 2008

First Posted Date

Oct 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2010

Last Update Posted Date

Apr 27, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	3-6 subjects each cohort. Escalate dose after safety evaluation of subjects in cohort	Drug: TAK-593

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TAK-593	Drug	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

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

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

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided