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The purpose of this study is to evaluate the potential inhibitory effects of patupilone on metabolism using midazolam and omeprazole as the respective probe drugs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patupilone and Omeprazole | Experimental | patupiloe + omeprazole |
|
| patupilone + midalzolam | Experimental | patupilone + midalzolam |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patupilone and Omeprazole | Drug |
| ||
| Patupilone + Midalzolam |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effects of patupilone on the pharmacokinetics of midazolam in patients with advanced malignancies. | Day 1 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h), Day 29 (0.5h, 1h, 1.5h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h) | |
| To evaluate the effects of patupilone on the pharmacokinetics of omeprazole in patients with advanced malignancies | Day 1 (0.33h (20m), 0.67h (40m), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h) |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of Patupilone when administered concomitantly with midazolam in patients with advanced malignancies. | at each visit (week 1, week 2, week 5, and end of study) | |
| To evaluate the safety and tolerability of Patupilone when administered concomitantly with omeprazole in patients with advanced malignancies. |
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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 Pharmeceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| Results can be found for CEPO906A2123 on the Novartis Clinical Trials Results Website | View source |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C093788 | epothilone B |
| D009853 | Omeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Drug |
|
| at each visit (week 1, week 2, week 5, and end of study) |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |