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| ID | Type | Description | Link |
|---|---|---|---|
| Study ID: 3283299 |
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This is a Phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy. Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before initiation of chemotherapy on Day 1. Subjects will record nausea and vomiting in the SPNV Subject Diary through Day 6. The quality of life assessment as measured by the Functional Living Index-Emesis Questionnaire (FLIE) will be used to measure the effect of chemotherapy-induced nausea and vomiting (CINV) on daily life. Blood samples for SCH 619734 pharmacokinetic assessments will be collected. The study is to be conducted in conformance with Good Clinical Practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCH 619734 Dose 1 | Experimental |
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| SCH 619734 Dose 2 | Experimental |
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| SCH 619734 Dose 3 | Experimental |
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| SCH 619734 Dose 4 | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH 619734 Dose 1 | Drug | SCH 619734 10 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles) |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the overall complete response rate (no emesis and no use of rescue medication from 0 through 120 hours following initiation of cisplatin-based chemotherapy). | Days 1 through 6. |
| Measure | Description | Time Frame |
|---|---|---|
| The key secondary efficacy endpoints are the complete response rates for the acute (0 through 24 hours) and delayed (>24 through 120 hours) phases of CINV. | Days 1 through 6. | |
| The key secondary safety endpoints are adverse events, physical examinations, vital signs, electrocardiograms, and safety laboratory values. |
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Inclusion Criteria:
Subject is 18 years of age or older.
Subject has never been treated with cisplatin and is to receive first course of cisplatin-based chemotherapy (>=70 mg/m^2).
Subject has a Karnofsky performance score of >=60.
Subject has a predicted life expectancy of >=3 months.
Subject has adequate bone marrow, kidney, and liver function as evidenced by:
Subject is able to read, understand, and complete the questionnaires.
Exclusion Criteria:
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| SCH 619734 Dose 2 | Drug | SCH 619734 25 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles) |
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| SCH 619734 Dose 3 | Drug | SCH 619734 100 mg (2 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles) |
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| SCH 619734 Dose 4 | Drug | SCH 619734 200 mg (4 capsules) x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles) |
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| Placebo | Drug | Matching placebo x 1 orally approximately 2 hours prior to the administration of the first chemotherapeutic agent on Day 1 of Cycle 1 and on Day 1 of all subsequent cycles (up to five additional cycles) |
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| Throughout the study and up to 30 days after the subject completes or discontinues from the study. |
| ID | Term |
|---|---|
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C578834 | rolapitant |
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