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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_005 |
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The purpose of this study is to assess the safety and tolerability of MK-0457(VX-680), an Aurora kinase inhibitor, in participants with advanced solid tumors. Bioavailability of the oral formulation will also be assessed. The primary study hypothesis is that administration of MK-0457 is sufficiently safe and tolerated to permit further study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-0457 | Experimental | Participants received MK-0457 at assigned dose as a continuous intravenous infusion (CIV) over 24 hours; one group of participants also received MK-0457 100 mg capsules, orally, prior to the CIV. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0457 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) | Up to 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in standard uptake value (SUV) in fluorodeoxyglucose positron emission tomography (FDG-PET) scans | Predose, and at end of Cycles 2 and 6 (up to approximately 4 months) | |
| Overall Tumor Response Per Response Evaluation Criteria in Solid Tumors (RECIST) |
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Inclusion Criteria:
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 |
|---|---|---|---|
| 20386909 | Derived | Traynor AM, Hewitt M, Liu G, Flaherty KT, Clark J, Freedman SJ, Scott BB, Leighton AM, Watson PA, Zhao B, O'Dwyer PJ, Wilding G. Phase I dose escalation study of MK-0457, a novel Aurora kinase inhibitor, in adult patients with advanced solid tumors. Cancer Chemother Pharmacol. 2011 Feb;67(2):305-14. doi: 10.1007/s00280-010-1318-9. Epub 2010 Apr 13. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C484810 | tozasertib |
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| Pre-dose through post-study visit (up to 3 years) |