Solid TumorsPhase 1NCT00773929
Safety Study of TAK-593 Given Orally in Subjects With Nonhematologic Advanced Cancer
A Phase 1 study testing TAK-593 in people with Solid Tumors, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- TAK-593
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Apr 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
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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.
- Ability to swallow and retain oral medication
- Meet study specific laboratory test standards for bone marrow function, liver function, blood pressure, and renal function.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Phase I Clinical and Pharmacokinetic Study of Oral TAK-593 in Subjects With Nonhematologic Advanced Cancer
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.
- Conditions
- Solid Tumors
- Being tested
- TAK-593
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-593Drug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3-6 subjects each cohort. Escalate dose after safety evaluation of subjects in cohort Receives: Drug: TAK-593 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593
Measured: 18-24 months
Secondary outcomes (1)
Response outcomes including objective response and clinical benefit response.
Measured: 18-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773929
- Sponsor's protocol ID
- TAK-593_101
- Status last verified
- Apr 2010
- First submitted
- 15 Oct 2008
- Last updated
- 27 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase I Clinical and Pharmacokinetic Study of Oral TAK-593 in Subjects With Nonhematologic Advanced Cancer
- ClinicalTrials.gov ID
- NCT00773929
- Acronym / sponsor ID
- TAK-593_101
- Conditions
- Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 16 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TAK-5933-6 subjects each cohort. Escalate dose after safety evaluation of subjects in cohort |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAK-593Tablets 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 | Drug | 1 |
Primary outcome
Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593
Time frame: 18-24 months
1 secondary outcome
Response outcomes including objective response and clinical benefit response.
Time frame: 18-24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Millennium Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-593 in people with Solid Tumors, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Toxicities of TAK-593 Pharmacokinetic parameters of TAK-593 (time frame: 18-24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2010.