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| ID | Type | Description | Link |
|---|---|---|---|
| MK0429-011 | |||
| 2006_013 |
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This two part study will evaluate the safety and tolerability of MK0429 in addition to assessing it's pharmacokinetic profile and pharmacodynamic response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1600 mg twice a day | Experimental | MK0429 |
|
| 200 mg twice a day | Experimental | MK0429 |
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| 800 mg twice a day | Experimental | MK0429 |
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| 400 mg twice a day | Experimental | MK0429 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparator: MK0429 | Drug | Part 1 - MK3328 of 1600 mg twice a day for 4 weeks given to men with hormone refractory prostate cancer and metastatic bone. Disease. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of 4 weeks of MK0429 therapy. | up to 14 days following last dose of medication |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Pharmacokinetic profile of MK0429 and pharmacodynamic responses to treatment of MK0429 | 4 weeks | |
| Part 2: Pharmacokinetic profile of MK0429 [Time frame 4 weeks] and pharmacodynamic responses to treatment of MK0429 [Time frame 8 weeks] | 4 weeks and 8 weeks |
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Inclusion Criteria:
Eligible patients must have:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20398037 | Result | Rosenthal 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Comparator: MK0429 | Drug | Part 2- MK3328 of 200 mg twice a day for 4 weeks to men with hormone refractory prostate cancer and metastatic bone disease. |
|
| Comparator: MK0429 | Drug | Part 1- MK3328 of 800mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease. |
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| Comparator: MK0429 | Drug | Part 2 - MK3328 of 400 mg twice a day for 8 weeks to men with hormone refractory prostate cancer and metastatic bone disease. |
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |