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| ID | Type | Description | Link |
|---|---|---|---|
| Formerly-0304AHEC | |||
| MK-0869-097 | Other Identifier | Merck Protocol Number | |
| 2004_099 | Other Identifier | Telerx Protocol Number |
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This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants treated with emetogenic cancer chemotherapies that include either cisplatin, cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when treated with a previously administered chemotherapy regimen that is planned to be repeated will be enrolled in this study. In the double-blind Part 1 of this study, enrolled participants will be randomized to receive either aprepitant or standard therapy. In Part 2 of this study, enrolled participants will receive open-label aprepitant.
The duration of treatment is the first 4 days of one 28-day cycle (Cycle 1). Participants who successfully complete Cycle 1 may be eligible to participate for 9 subsequent optional, open-label, 28-day cycles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Aprepitant | Experimental | Day 1: aprepitant 125 mg orally (PO), ondansetron 0.15 mg/kg x 3 doses intravenously (IV), dexamethasone 8 mg PO. Day 2: aprepitant 80 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 4 mg PO. Day 3: aprepitant 80 mg PO, dexamethasone 4 mg PO. Day 4: dexamethasone 4 mg PO. For 1 cycle and up to 9 subsequent optional cycles. |
|
| Part 1: Standard Therapy | Active Comparator | Day 1: placebo to aprepitant 125 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 16 mg PO. Day 2: placebo to aprepitant 80 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 8 mg PO. Day 3: placebo for aprepitant 80 mg PO, dexamethasone 8 mg PO. Day 4: dexamethasone 8 mg PO. For 1 cycle; participants may receive open-label aprepitant for up to 9 subsequent optional cycles. |
|
| Part 2: Aprepitant | Active Comparator | Day 1: aprepitant 125 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 8 mg PO. Day 2: aprepitant 80 mg PO, ondansetron 0.15 mg/kg x 3 doses IV, dexamethasone 4 mg PO. Day 3: aprepitant 80 mg PO, dexamethasone 4 mg PO. Day 4: dexamethasone 4 mg PO. For up to 10 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aprepitant | Drug | aprepitant capsules |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycle 1) | Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience a Complete Response (CR) to Anti-emetic Therapy (Cycle 1) | Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1 | |
| Percentage of Participants Who Experience Absence of Nausea (Cycle 1) | Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18985740 | Background | Gore L, Chawla S, Petrilli A, Hemenway M, Schissel D, Chua V, Carides AD, Taylor A, Devandry S, Valentine J, Evans JK, Oxenius B; Adolescent Aprepitant in Cancer Study Group. Aprepitant in adolescent patients for prevention of chemotherapy-induced nausea and vomiting: a randomized, double-blind, placebo-controlled study of efficacy and tolerability. Pediatr Blood Cancer. 2009 Feb;52(2):242-7. doi: 10.1002/pbc.21811. |
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| ondansetron |
| Drug |
ondansetron IV preparation |
|
| dexamethasone | Drug | dexamethasone tablets |
|
| placebo to aprepitant | Drug | Matching placebo to aprepitant capsules |
|
| placebo to dexamethasone | Drug | Matching placebo to dexamethasone tablets |
|
| rescue medication | Drug | Participants are allowed to take rescue medication throughout for nausea or vomiting. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are: 5-HT3 antagonists, phenothiazines, butyrophenones, benzamides, corticosteroids, benzodiazepines, domperidone, H1-receptor antagonist, and piperazine derivatives. |
|
| Percentage of Participants Who Experience Absence of Vomiting (Cycle 1) | Up to 120 hours after initiation of emetogenic chemotherapy in Cycle 1 |
| Percentage of Participants Who Experience Serious Adverse Events (Cycles 2-10) | Up to 14 days after last dose of anti-emetic therapy in Cycles 2-10 (Up to 10.5 months) |
| Percentage of Participants Who Experience Study-drug-related Adverse Events (Cycles 2-10) | Up to 14 days after last dose of anti-emetic therapy in Cycles 2-10 (Up to 10.5 months) |
| Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycles 2-10) | Up to Day 4 of Cycles 2-10 (Up to 10 months) |
| Percentage of Participants Who Experience Serious Adverse Events (Cycle 1) | Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days) |
| Percentage of Participants Who Experience Serious Study-drug-related Adverse Events (Cycle 1) | Up to 14 days after last dose of anti-emetic therapy in Cycle 1 (Up to 18 days) |
| Percentage of Participants Who Discontinue Study Due to Study-drug-related Adverse Events (Cycle 1) | Up to Day 4 of Cycle 1 |
| Aprepitant Plasma Drug Concentration Profiles and Pharmacokinetics | Up to 24 hours after first dose of aprepitant |
| ID | Term |
|---|---|
| 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 |
|---|---|
| D000077608 | Aprepitant |
| D017294 | Ondansetron |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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