Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Aurora kinase inhibitor, MSC1992371A
AS703569/gemcitabine · 1 trial · 1 indication
To determine the maximum tolerated dose (MTD) during a 21-day cycle, for each of the two planned regimens using combination therapy with AS703569 and gemcitabine.
| Arm | Type | Description |
|---|---|---|
| Regimen 1: AS703569/gemcitabine | EXPERIMENTAL | Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle |
| Regimen 2: AS703569/gemcitabine | EXPERIMENTAL | AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle |
| Name | Type | Description |
|---|---|---|
| AS703569/gemcitabine | DRUG | Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next. Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle. |
Inclusion Criteria: Histologically/cytologically confirmed diagnosis of measurable or assessable malignancy, who meets one of the following conditions: Subject with a tumour for which gemcitabine is approved, Subject with a tumour for which gemcitabine is considered standard of care, Subject with ...
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