Prostate CancerPhase 2NCT00777959
Bicalutamide and Ridaforolimus in Men With Prostate Cancer (MK-8669-002)
A Phase 2 study testing ridaforolimus (MK8669) and open-label ridaforolimus (MK8669) in people with Prostate Cancer, run by Merck Sharp & Dohme LLC.
Trial summary
This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer. 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?
- ridaforolimus (MK8669) and open-label ridaforolimus (MK8669)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Jun 2011
- 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
- Confirmed adenocarcinomas of the prostate.
- Evidence of metastatic disease
- Evidence of disease progression including one of the following: increasing levels of PSA, progressive lymph node disease, or worsening bone scan
- PSA level is greater or equal to 7 ng/ml.
- ECOG performance status less than or equal to 1
Who cannot join
- Previously received bicalutamide, flutamide, or nilutamide within the past 12 months (except for a period of use less than 30 days long).
- Prior chemotherapy for prostate cancer
- Prior rapamycin or rapamycin analogs, including ridaforolimus, everolimus, or temsirolimus.
- Patient is receiving an opioid or narcotic analgesic for pain due to prostate cancer
- Patient has pain related to prostate cancer that warrants the initiation of chemotherapy
About this study
Official title: A Phase II Randomized, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus (Ridaforolimus) in Men With Asymptomatic, Metastatic Castrate-resistant Prostate Cancer
This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.
Read the detailed description
Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.
- Conditions
- Prostate Cancer
- Being tested
- ridaforolimus (MK8669), Comparator: Placebo, open-label ridaforolimus (MK8669)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ridaforolimus (MK8669)Drug
Also called AP23573
Three 10 mg tablets administered daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression.
Comparator: PlaceboDrug
Three tablets of matching placebo to ridaforolimus administered daily for 5 consecutive days each week followed by 2 days without matching placebo and on 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression.
open-label ridaforolimus (MK8669)Drug
Also called AP23573
Single dose of three 10 mg tablets ridaforolimus on Day 1, and 50 mg bicalutamide once daily starting on Day 2. On Day 8, patients will begin taking three 10 mg tablets of ridaforolimus daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide once daily for 7 days each week. Treatment will continue until disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | ridaforolimus (MK8669)+ bicalutamide Receives: Drug: open-label ridaforolimus (MK8669) |
| Ridaforolimus | Experimental | ridaforolimus (MK8669)+ bicalutamide Receives: Drug: ridaforolimus (MK8669) |
| Placebo | Placebo comparator | Placebo + bicalutamide Receives: Drug: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
30% Prostate specific antigen (PSA) decline within 12 weeks
Measured: 12 weeks
Number of dose limiting toxicities (DLTs)
Measured: Day 1 to Day 35
Secondary outcomes (4)
Prostate specific antigen (PSA) response rate
Measured: 12 weeks
Number of patients with progression free survival (PFS)
Measured: 12 weeks
Time to prostate specific antigen (PSA) progression
Measured: 12 weeks
Pharmacokinetics Maximum Concentration (Cmax), Time to Maximum Plasma Concentration (Tmax), Area Under the Concentration Versus Time Curve (AUC) of Ridaforolimus
Measured: 30 Minutes to 24 hour postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionMay 2011
- Study completionJun 2011
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.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00777959
- Sponsor's protocol ID
- 8669-002
- Other IDs
- 2008_572
- Status last verified
- Aug 2015
- First submitted
- 21 Oct 2008
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meulenbeld HJ, de Bono JS, Tagawa ST, Whang YE, Li X, Heath KH, Zandvliet AS, Ebbinghaus SW, Hudes GR, de Wit R. Tolerability, safety and pharmacokinetics of ridaforolimus in combination with bicalutamide in patients with asymptomatic, metastatic castration-resistant prostate cancer (CRPC). Cancer Chemother Pharmacol. 2013 Oct;72(4):909-16. doi: 10.1007/s00280-013-2250-6. Epub 2013 Aug 7.
PubMed 23921574
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Placebo Controlled Clinical Trial to Study the Efficacy and Safety of Bicalutamide With or Without Deforolimus (Ridaforolimus) in Men With Asymptomatic, Metastatic Castrate-resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT00777959
- Acronym / sponsor ID
- 8669-002
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Ariad Pharmaceuticals
- Study start
- Oct 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 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.
This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.
Detailed description
Ridaforolimus (MK8669/AP23573) was also known as deforolimus until May 2009.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: open-label ridaforolimus (MK8669)ridaforolimus (MK8669)+ bicalutamide |
| Ridaforolimus | Experimental | Drug: ridaforolimus (MK8669)ridaforolimus (MK8669)+ bicalutamide |
| Placebo | Placebo comparator | Drug: Comparator: PlaceboPlacebo + bicalutamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed adenocarcinomas of the prostate.
- Evidence of metastatic disease
- Evidence of disease progression including one of the following: increasing levels of PSA, progressive lymph node disease, or worsening bone scan
- PSA level is greater or equal to 7 ng/ml.
- ECOG performance status less than or equal to 1
Key exclusion criteria (5 listed)
- Previously received bicalutamide, flutamide, or nilutamide within the past 12 months (except for a period of use less than 30 days long).
- Prior chemotherapy for prostate cancer
- Prior rapamycin or rapamycin analogs, including ridaforolimus, everolimus, or temsirolimus.
- Patient is receiving an opioid or narcotic analgesic for pain due to prostate cancer
- Patient has pain related to prostate cancer that warrants the initiation of chemotherapy
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 |
|---|---|---|
| ridaforolimus (MK8669)Also: AP23573Three 10 mg tablets administered daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression. | Drug | Ridaforolimus |
| Comparator: PlaceboThree tablets of matching placebo to ridaforolimus administered daily for 5 consecutive days each week followed by 2 days without matching placebo and on 50 mg tablet of bicalutamide administered once daily for 7 days each week. Treatment will continue until disease progression. | Drug | Placebo |
| open-label ridaforolimus (MK8669)Also: AP23573Single dose of three 10 mg tablets ridaforolimus on Day 1, and 50 mg bicalutamide once daily starting on Day 2. On Day 8, patients will begin taking three 10 mg tablets of ridaforolimus daily for 5 consecutive days each week followed by 2 days without ridaforolimus and one 50 mg tablet of bicalutamide once daily for 7 days each week. Treatment will continue until disease progression. | Drug | Open Label |
Primary outcome
30% Prostate specific antigen (PSA) decline within 12 weeks
Time frame: 12 weeks
Number of dose limiting toxicities (DLTs)
Time frame: Day 1 to Day 35
4 secondary outcomes
Prostate specific antigen (PSA) response rate
Time frame: 12 weeks
Number of patients with progression free survival (PFS)
Time frame: 12 weeks
Time to prostate specific antigen (PSA) progression
Time frame: 12 weeks
Pharmacokinetics Maximum Concentration (Cmax), Time to Maximum Plasma Concentration (Tmax), Area Under the Concentration Versus Time Curve (AUC) of Ridaforolimus
Time frame: 30 Minutes to 24 hour postdose
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 19 Aug 2015.
- Results publication: PubMed 23921574Meulenbeld HJ, de Bono JS, Tagawa ST, Whang YE, Li X, Heath KH, Zandvliet AS, Ebbinghaus SW, Hudes GR, de Wit R. Tolerability, safety and pharmacokinetics of ridaforolimus in combination with bicalutamide in patients with asymptomatic, metastatic castration-resistant prostate cancer (CRPC). Cancer Chemother Pharmacol. 2013 Oct;72(4):909-16. doi: 10.1007/s00280-013-2250-6. Epub 2013 Aug 7.
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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
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ridaforolimus (MK8669) and open-label ridaforolimus (MK8669) in people with Prostate Cancer, run by Merck Sharp & Dohme LLC.
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 5 inclusion and 5 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 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
30% Prostate specific antigen (PSA) decline within 12 weeks (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT00777959, 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 19 Aug 2015.