Prostate CancerPhase 2NCT01046916
Safety and Efficacy Study of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer and a Rising Prostate-specific Antigen
A Phase 2 study testing TAK-700 in people with Prostate Cancer, run by Millennium Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without radiographic evidence of metastases who have a rising prostate-specific antigen (PSA). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- 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
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2010to Mar 2013
- Phase
- Phase 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
- Each patient must meet all of the following inclusion criteria:
- Male patients 18 years or older
- Eastern Cooperative Oncology Group performance status 0-2
- Male patients who Practice effective barrier contraception during study and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse.
- Voluntary written consent
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma without radiographic evidence of metastasis but with a rising PSA during or following the patient's most recent antineoplastic therapy despite castrate concentrations of testosterone
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- Baseline PSA must be greater than or equal to 2 ng/mL and PSA doubling time must be less than or equal to 8 months OR baseline PSA must be greater than or equal to 8 ng/mL if PSA doubling time is greater than 8 months
- Has undergone orchiectomy or will continue receiving GnRH analogue therapy
- Meet screening laboratory values as specified in protocol
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Known hypersensitivity to TAK-700 or related compounds
- Received any of the following within 30 days prior to the first dose of TAK-700: any investigational compound; prior herbal product known to decrease PSA; radiation therapy for prostate cancer; OR chronic therapy with corticosteroids
- Received prior therapy with aminoglutethimide or ketoconazole
- Received antiandrogen therapy within 4 weeks for flutamide and 6 weeks for all others prior to first dose of study drug
- Received prior chemotherapy for prostate cancer
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- Current bladder neck outlet obstruction caused by prostate cancer, current spinal cord compression, or current bilateral hydronephrosis
- Symptoms that investigator deems related to prostate cancer
- Diagnosis or treatment of another malignancy within 2 years preceding first dose of study drug except nonmelanoma skin cancer or in situ malignancy completely resected
- History of adrenal insufficiency
- Uncontrolled cardiovascular condition
- Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
- Unwilling or unable to comply with protocol
- Major surgery or serious infection within 14 days of first dose of TAK-700
- Life-threatening illness unrelated to cancer
- Uncontrolled nausea, vomiting or diarrhea
- Known gastrointestinal disease or procedure that could interfere with oral absorption or tolerance of TAK-700
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
University of Wisconsin Hospitals and Clinics
Madison, Wisconsin, 53705
Oregon Health and Sciences University
Portland, Oregon, 97239
About this study
Official title: A Phase 2 Multicenter Open-label Study Evaluating the Safety and Efficacy of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer (CRPC) and a Rising Prostate-specific Antigen (PSA)
This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without radiographic evidence of metastases who have a rising prostate-specific antigen (PSA).
- Conditions
- Prostate Cancer
- Being tested
- TAK-700
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-700Drug
TAK-700 will be administered orally (PO) twice daily (BID) on a continuous schedule
| Study group | Role | What they receive |
|---|---|---|
| TAK-700 | Experimental | Not described Receives: Drug: TAK-700 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 3 months of TAK-700 treatment
Measured: 3 months
Secondary outcomes (5)
To determine PSA response rate (PSA decline of at least 90%, 50% and 30% from baseline)at 3 and 6 months
Measured: 3 and 6 months
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 6 months of TAK-700 treatment
Measured: 6 months
To determine time to PSA progression, time to metastases, and duration of progression-free survival
Measured: Evidence of PSA or disease progression
To monitor changes in endocrine markers
Measured: Evidence of PSA or disease progression
To evaluate the safety of TAK-700
Measured: Evidence of PSA or disease progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 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
- NCT01046916
- Sponsor's protocol ID
- C21001
- Status last verified
- Mar 2016
- First submitted
- 11 Jan 2010
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hussain M, Corn PG, Michaelson MD, Hammers HJ, Alumkal JJ, Ryan CJ, Bruce JY, Moran S, Lee SY, Lin HM, George DJ; Prostate Cancer Clinical Trials Consortium, a program of the Department of Defense Prostate Cancer Research Program and the Prostate Cancer Foundation. Phase II study of single-agent orteronel (TAK-700) in patients with nonmetastatic castration-resistant prostate cancer and rising prostate-specific antigen. Clin Cancer Res. 2014 Aug 15;20(16):4218-27. doi: 10.1158/1078-0432.CCR-14-0356. Epub 2014 Jun 25.
PubMed 24965748
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 2 Multicenter Open-label Study Evaluating the Safety and Efficacy of TAK-700 in Patients With Nonmetastatic Castration-resistant Prostate Cancer (CRPC) and a Rising Prostate-specific Antigen (PSA)
- ClinicalTrials.gov ID
- NCT01046916
- Acronym / sponsor ID
- C21001
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Jan 2010 (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.
This is a multicenter phase 2 open-label single-arm study that will evaluate the safety and efficacy of TAK-700 in patients with castration-resistant prostate cancer (CRPC) without radiographic evidence of metastases who have a rising prostate-specific antigen (PSA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAK-700 | 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 (9 listed)
- Male patients 18 years or older
- Eastern Cooperative Oncology Group performance status 0-2
- Male patients who Practice effective barrier contraception during study and for 4 months after the last dose of study drug, OR Abstain from heterosexual intercourse.
- Voluntary written consent
- Histologically or cytologically confirmed diagnosis of prostate adenocarcinoma without radiographic evidence of metastasis but with a rising PSA during or following the patient's most recent antineoplastic therapy despite castrate concentrations of testosterone
Key exclusion criteria (17 listed)
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study:
- Known hypersensitivity to TAK-700 or related compounds
- Received any of the following within 30 days prior to the first dose of TAK-700: any investigational compound; prior herbal product known to decrease PSA; radiation therapy for prostate cancer; OR chronic therapy with corticosteroids
- Received prior therapy with aminoglutethimide or ketoconazole
- Received antiandrogen therapy within 4 weeks for flutamide and 6 weeks for all others prior to 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-700TAK-700 will be administered orally (PO) twice daily (BID) on a continuous schedule | Drug | TAK-700 |
Primary outcome
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 3 months of TAK-700 treatment
Time frame: 3 months
5 secondary outcomes
To determine PSA response rate (PSA decline of at least 90%, 50% and 30% from baseline)at 3 and 6 months
Time frame: 3 and 6 months
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 6 months of TAK-700 treatment
Time frame: 6 months
To determine time to PSA progression, time to metastases, and duration of progression-free survival
Time frame: Evidence of PSA or disease progression
To monitor changes in endocrine markers
Time frame: Evidence of PSA or disease progression
To evaluate the safety of TAK-700
Time frame: Evidence of PSA or disease progression
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.
- Derived from this study: PubMed 24965748Hussain M, Corn PG, Michaelson MD, Hammers HJ, Alumkal JJ, Ryan CJ, Bruce JY, Moran S, Lee SY, Lin HM, George DJ; Prostate Cancer Clinical Trials Consortium, a program of the Department of Defense Prostate Cancer Research Program and the Prostate Cancer Foundation. Phase II study of single-agent orteronel (TAK-700) in patients with nonmetastatic castration-resistant prostate cancer and rising prostate-specific antigen. Clin Cancer Res. 2014 Aug 15;20(16):4218-27. doi: 10.1158/1078-0432.CCR-14-0356. Epub 2014 Jun 25.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAK-700 in people with Prostate Cancer, run by Millennium Pharmaceuticals, Inc. at 3 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 9 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 3 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 phase mean?
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?
To determine the percentage of patients who achieve a PSA less than or equal to 0.2 ng/mL following 3 months of TAK-700 treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01046916, which also lists 1 linked publication.
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.