Clinical trial · Interventional
Bicalutamide and Ridaforolimus in Men With Prostate Cancer (MK-8669-002)
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
NCT00777959CI-TRIAL-00018884completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will look to see if the combination of ridaforolimus and bicalutamide works better than placebo and bicalutamide in men with prostate cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: Placebo | Drug | — | UNRESOLVED |
| open-label ridaforolimus (MK8669) | Drug | — | UNRESOLVED |
| ridaforolimus (MK8669) | Drug | Ridaforolimus | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Open Label
- description
- ridaforolimus (MK8669)+ bicalutamide
- interventionNames
- Drug: open-label ridaforolimus (MK8669)
- type
- EXPERIMENTAL
- label
- Ridaforolimus
- description
- ridaforolimus (MK8669)+ bicalutamide
- interventionNames
- Drug: ridaforolimus (MK8669)
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo + bicalutamide
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria : * 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
References
Publications (1)
- RESULTMeulenbeld 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. PMID 23921574