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This multicenter, open-label study will evaluate the effect of posaconazole on the pharmacokinetics of RO5503781, the relative bioavailability of two new RO5503781 formulations, and the effect of food on the pharmacokinetics of RO5503781 in patients with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extension | Experimental |
| |
| Part 1: Drug-drug interaction | Experimental |
| |
| Part 2: Relative bioavailability | Experimental |
| |
| Part 3: Food effect | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO5503781 | Drug | Single dose on Day 1 (high fat, low fat, or fasted), Day 10 (fasted, low fat, or high fat), and Day 19 (low fat, fasted, or high fat) in a crossover design |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Area under the concentration-time curve (AUC) | 22 days | |
| Part 1: Maximum concentration (Cmax) | 22 days | |
| Part 1: Change in serum macrophage inhibitory cytokine-1 (MIC-1) | from baseline to Day 22 | |
| Part 2: Relative bioavailability: Area under the concentration-time curves (AUCs) | 22 days | |
| Part 3: Food effect: Area under the concentration-time curves (AUCs) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events in combination with posaconazole | 28 days | |
| Safety: Incidence of adverse events (new formulations) | 28 days | |
| Safety: Incidence of adverse events (optional treatment extension) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scottsdale | Arizona | 85258 | United States | |||
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| RO5503781 | Drug | Daily for 5 days followed by 23 days rest per cycle |
|
| RO5503781 | Drug | Single doses of current formulation, optimized MBP formulation and new SDP formulation, Days 1, 8 and 15 in a crossover design |
|
| RO5503781 | Drug | Single doses Days 1 and 11 |
|
| posaconazole | Drug | Multiple doses Days 8-14 |
|
| approximately 1 year |
| Dallas |
| Texas |
| 75230 |
| United States |
| Toronto | Ontario | M5G 2M9 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C101425 | posaconazole |
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