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This is a Phase I trial. Some specific protocol information is proprietary and is not publicly available at this time. Full information will be provided to trial participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Regimen 1 |
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| 2 | Active Comparator | Regimen 2 |
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| 3 | Active Comparator | Regimen 3 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AS703569 | Drug | Regimen 1: 3 mg/m2 /day given orally on Days 1 and 8 during a 21-day cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| Number and proportion of subjects experiencing: at least a Dose-Limiting Toxicity (DLT) in each cohort during the first cycle. | Undefined |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and urine PK parameters of AS703569, genetic markers and potential markers of clinical and biological response. | Undefined | |
| Number and proportion of subjects with Progressive Disease as assessed at the end of every other cycle. | Undefined |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Narmyn Rejeb, MD | Merck Serono S.A., Geneva | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EMD Serono Medical Information Office | Rockland | Massachusetts | 02370 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23832397 | Result | Mita M, Gordon M, Rejeb N, Gianella-Borradori A, Jego V, Mita A, Sarantopoulos J, Sankhala K, Mendelson D. A phase l study of three different dosing schedules of the oral aurora kinase inhibitor MSC1992371A in patients with solid tumors. Target Oncol. 2014 Sep;9(3):215-24. doi: 10.1007/s11523-013-0288-3. Epub 2013 Jul 6. |
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| ID | Term |
|---|---|
| C000592140 | MSC1992371A |
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| AS703569 | Drug | Regimen 2: 2 mg/m2/day given orally on Days 1, 2, and 3 of a 21-day cycle |
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| AS703569 | Drug | Regimen 3: 10 mg/m2/day given orally on Days 1, 2, 3 and Days 8, 9, 10 of a 21-day cycle |
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