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This study will evaluate the Maximum Tolerated Dose and dose limiting toxicity of gimatecan administered orally in patients with advanced solid tumors
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Daily times five schedule | Experimental |
| |
| Continuous schedule, twice daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| gimatecan | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Presence of dose limiting toxicities in a 56-day treatment period | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability assessed by adverse events, serious adverse events | 112 days | |
| pharmacokinetics of gimatecan and its metabolites(s) | 91 days | |
| response rate assessed by anti-tumor activity |
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Inclusion criteria:
Exclusion criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Vancouver | British Columbia | Canada | |||
| MD Anderson Cancer Center - Orlando |
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| 112 days |
| investigate tumor-specific mutations | 57 days |
| Evaluate activity signal for both dose schedules at MTD in ovarian, endometrial, and SCLC | 56 days |
| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
| Novartis Investigative Site | Copenhagen | DK-2100 | Denmark |
| Novartis Investigative Site | Dijon | 21034 | France |
| Novartis Investigative Site | Paris | 75005 | France |
| Novartis Investigative Site | Saint-Herblain | 44805 | France |
| Novartis Investigative Site | Toulouse | 31052 | France |
| Novartis Investigative Site | Mainz | 55101 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Enschede | Netherlands |
| Novartis Investigative Site | Oslo | 310 | Norway |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| ID | Term |
|---|---|
| C433984 | ST 1481 |
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