Prostatic NeoplasmsPhase 1/2TAK-700NCT00569153
Safety Study of TAK-700 in Subjects With Prostate Cancer.
A Phase 1/2 study testing TAK-700 in people with Prostatic Neoplasms, run by Millennium Pharmaceuticals, Inc. at 19 sites in United States.
Trial summary
The purpose of this study is to determine the safety and tolerability of TAK-700 in patients with asymptomatic metastatic, androgen independent prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- TAK-700
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 19 sitesUnited States
- Study dates
- Apr 2008to Feb 2013
- Phase
- Phase 1/2
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is male and at least 18 years of age.
- Subject has histologically- or cytologically-confirmed prostate adenocarcinoma with metastatic, progressive disease while on androgen deprivation therapy.
- Subject has radiograph-documented (computed tomography, magnetic resonance imaging or x-ray) metastatic disease.
- Subject has undergone orchiectomy or is expected to continue receiving luteinizing hormone-releasing hormone analogue therapy, and has a testosterone level of <50 ng/dL at screening.
- Subject has discontinued all antiandrogen therapy (within 30 days for flutamide and within 6 weeks for all others) prior to their first dose of study drug.
- Subject has a prostate-specific antigen level ≥5 ng/mL.
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- Subject meets all screening laboratory values as specified in the protocol.
- Subject has a screening ejection fraction that is above the lower limit of the institutional normal range.
- Subject has ECOG performance status of 0 to 2.
- Subject has normal or, in the opinion of the investigator, clinically insignificant, physical examination findings, ECG and chest x-ray results.
- Subjects, even if surgically sterilized (ie, status postvasectomy), who: agree to practice effective barrier contraception during the entire study treatment period and for 4 months after the last dose of study drug, or agree to completely abstain from heterosexual intercourse.
Who cannot join
- Subject has known hypersensitivity to TAK-700 or related compounds.
- Subject has received prior therapy with aminoglutethimide or ketoconazole within 30 days prior to the first dose of study drug.
- Subject has received prior chemotherapy for prostate cancer.
- Subject has received any investigational compound within 30 days prior to first dose of study drug.
- Subject has received prior herbal product known to decrease prostate-specific antigen levels (eg, Saw Palmetto, PC-SPES) within 30 days prior to the first dose of study drug.
- Subject has received radiation therapy for prostate cancer within 30 days prior to first dose of study drug.
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- Chronic therapy with oral or other systemically administered corticosteroids, such as prednisone, within 30 days prior to Screening. Chronic therapy is defined as the use of corticosteroids for more than 7 days within a 30-day period.
- Subject has current spinal cord compression, current bilateral hydronephrosis, or current bladder neck outlet obstruction.
- Subject has a history of adrenal insufficiency.
- Subject has a history of myocardial infarction, ischaemic symptomatic heart disease, cardiac arrhythmias or thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 12 months prior to first dose of study drug.
- Subject has any symptoms which the investigator deems related to prostate cancer, i.e., bone pain, pelvic pain.
- Subject has a history of congestive heart failure (New York Heart Association Class II or greater.
- Subject has history of another malignancy other than basal cell carcinoma or state 1 squamous cell carcinoma of the skin, within the last 5 years.
- Subject has uncontrolled hypertension.
- Subject is known to have HIV infection, chronic Hepatitis B or C or any other serious medical condition or psychiatric illness that might affect life expectancy or make it difficult to successfully manage and follow the subject according to protocol.
- Subject is unable to understand verbal or written English or any other language for which a certified translation of the institutional review board (IRB)-approved informed consent has been provided.
- Subject is unwilling or unable to comply with the protocol or cooperate fully with the investigator and site personnel.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
South Florida Medical Research
Aventura, Florida
USC Westside Prostate Cancer Center
Beverly Hills, California
Gabrail Cancer Center
Canton, Ohio
Northwestern University Medical Center
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
University of Chicago Comprehensive Cancer Center
Chicago, Illinois
University of Chicago Pharmacy
Chicago, Illinois
Cleveland Clinic
Cleveland, Ohio, 44195
Taussig Cancer Institute
Cleveland, Ohio
Hematology/Oncology Associates of Central New York
East Syracuse, New York
Evanston Hospital
Evanston, Illinois
Kellogg Pharmacy - Evanston Hospital
Evanston, Illinois
NorthShore University HealthSystem
Evanston, Illinois
Florida Cancer Specialists
Fort Myers, Florida
Kellogg Cancer Care Center
Glenview, Illinois
University of Southern California
Los Angeles, California, 90048
The Angeles Clinic and Research Institute
Los Angeles, California
USC Norris Comprehensive Cancer Center
Los Angeles, California
Tennessee Oncology
Nashville, Tennessee
About this study
Official title: A Phase 1/2, Open-Label, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Metastatic, Androgen-Independent Prostate Cancer Subjects
The purpose of this study is to determine the safety and tolerability of TAK-700 in patients with asymptomatic metastatic, androgen independent prostate cancer.
- Conditions
- Prostatic Neoplasms
- Being tested
- TAK-700
- Keywords
- Androgen-independent prostate cancer, metastatic
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-700Drug
Phase 1 portion of study:
TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event.
Phase 2 portion of study:
Patients will receive one of 4 treatments:
- TAK-700 at 300 mg twice/day
- TAK-700 at 400 mg and 5 mg prednisone twice/day
- TAK-700 at 600 mg and 5 mg prednisone twice/day
- TAK-700 at 600 mg once/day in the morning
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (TAK-700) | Experimental | Not described Receives: Drug: TAK-700 |
| Arm 2 (TAK-700 at 400 mg & 5 mg prednisone) | Experimental | Not described Receives: Drug: TAK-700 |
| Arm 3 (TAK-700 at 600 mg & 5 mg prednisone) | Experimental | Not described Receives: Drug: TAK-700 |
| Arm 4 (TAK-700 at 600 mg) | Experimental | Not described Receives: Drug: TAK-700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of TAK-700 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
Measured: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.
Secondary outcomes (1)
Efficacy and pharmacokinetics (PSA response and/or objective disease response)
Measured: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2007 (estimated)
- Study startApr 2008
- Primary completionJan 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00569153
- Sponsor's protocol ID
- TAK-700_201
- Other IDs
- TAK-700-201
- Acronym
- TAK-700
- Status last verified
- Mar 2016
- First submitted
- 4 Dec 2007
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Metastatic, Androgen-Independent Prostate Cancer Subjects
- ClinicalTrials.gov ID
- NCT00569153
- Acronym / sponsor ID
- TAK-700 / TAK-700_201
- Conditions
- Prostatic Neoplasms
- Keywords
- Androgen-independent prostate cancer, metastatic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 6 Dec 2007 (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 tolerability of TAK-700 in patients with asymptomatic metastatic, androgen independent prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (TAK-700) | Experimental | Drug: TAK-700 |
| Arm 2 (TAK-700 at 400 mg & 5 mg prednisone) | Experimental | Drug: TAK-700 |
| Arm 3 (TAK-700 at 600 mg & 5 mg prednisone) | Experimental | Drug: TAK-700 |
| Arm 4 (TAK-700 at 600 mg) | Experimental | Drug: TAK-700 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subject is male and at least 18 years of age.
- Subject has histologically- or cytologically-confirmed prostate adenocarcinoma with metastatic, progressive disease while on androgen deprivation therapy.
- Subject has radiograph-documented (computed tomography, magnetic resonance imaging or x-ray) metastatic disease.
- Subject has undergone orchiectomy or is expected to continue receiving luteinizing hormone-releasing hormone analogue therapy, and has a testosterone level of <50 ng/dL at screening.
- Subject has discontinued all antiandrogen therapy (within 30 days for flutamide and within 6 weeks for all others) prior to their first dose of study drug.
Key exclusion criteria (17 listed)
- Subject has known hypersensitivity to TAK-700 or related compounds.
- Subject has received prior therapy with aminoglutethimide or ketoconazole within 30 days prior to the first dose of study drug.
- Subject has received prior chemotherapy for prostate cancer.
- Subject has received any investigational compound within 30 days prior to first dose of study drug.
- Subject has received prior herbal product known to decrease prostate-specific antigen levels (eg, Saw Palmetto, PC-SPES) within 30 days prior to the first dose of study drug.
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-700Phase 1 portion of study: TAK-700 dose escalation. Tablets administered orally, twice daily until disease progression or occurrence of an unacceptable adverse event. Phase 2 portion of study: Patients will receive one of 4 treatments: * TAK-700 at 300 mg twice/day * TAK-700 at 400 mg and 5 mg prednisone twice/day * TAK-700 at 600 mg and 5 mg prednisone twice/day * TAK-700 at 600 mg once/day in the morning | Drug | Arm 1 (TAK-700), Arm 2 (TAK-700 at 400 mg & 5 mg prednisone), Arm 3 (TAK-700 at 600 mg & 5 mg prednisone), Arm 4 (TAK-700 at 600 mg) |
Primary outcome
Safety and tolerability of TAK-700 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests.
Time frame: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.
1 secondary outcome
Efficacy and pharmacokinetics (PSA response and/or objective disease response)
Time frame: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.
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 4 Apr 2016.
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TAK-700 in people with Prostatic Neoplasms, run by Millennium Pharmaceuticals, Inc. at 19 sites 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 11 inclusion and 17 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 4 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety and tolerability of TAK-700 by evaluating adverse events, vital signs, physical examination findings, concomitant medications and laboratory tests. (time frame: Cycle 1: Weeks 1, 2, 3 and 4, then every 4 weeks thereafter.). 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 4 Apr 2016.