Clinical trial · Interventional
MK0429 Study in Prostate Cancer Patients With Metastatic Bone Disease (0429-011)
A Phase I, Randomized, Multicenter, Double-Blind Study of MK0429 in the Treatment of Men With Hormone Refractory Prostate Cancer and Metastatic Bone Disease
NCT00302471CI-TRIAL-00017654completedPhase 1ClinicalTrials.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 two part study will evaluate the safety and tolerability of MK0429 in addition to assessing it's pharmacokinetic profile and pharmacodynamic response.
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 |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: MK0429 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- 1600 mg twice a day
- description
- MK0429
- interventionNames
- Drug: Comparator: MK0429
- type
- EXPERIMENTAL
- label
- 200 mg twice a day
- description
- MK0429
- interventionNames
- Drug: Comparator: MK0429
- type
- EXPERIMENTAL
- label
- 800 mg twice a day
- description
- MK0429
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Eligible patients must have: * Prostate cancer * Bone metastases without symptoms * Lack of response to hormone therapy as evidenced by a rising PSA or clinical progression Exclusion Criteria: * Prostate cancer-related bone pain * Previously received bisphosphonate therapy (e.g. zoledronate) * Received any investigational treatment within the last 30 days
References
Publications (1)
- RESULTRosenthal MA, Davidson P, Rolland F, Campone M, Xue L, Han TH, Mehta A, Berd Y, He W, Lombardi A. Evaluation of the safety, pharmacokinetics and treatment effects of an alpha(nu)beta(3) integrin inhibitor on bone turnover and disease activity in men with hormone-refractory prostate cancer and bone metastases. Asia Pac J Clin Oncol. 2010 Mar;6(1):42-8. doi: 10.1111/j.1743-7563.2009.01266.x. PMID 20398037