Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01594749 | Efficacy and Safety of Fosaprepitant Dimeglumine in Preventing Chemotherapy-Induced Nausea and Vomiting (MK-0517-031) | PHASE3 | COMPLETED | 1,015 | — | — | Sep 24, 2012 | Nov 3, 2014 | Sep 4, 2018 | - | — |
| NCT00619359 | Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017) | PHASE3 | COMPLETED | 2,322 | — | — | Feb 1, 2008 | Jun 1, 2009 | Mar 21, 2017 | - | — |
A Complete Response was defined as no vomiting and no use of rescue medication.
The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever.
The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented.
The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.
| Arm | Type | Description |
|---|---|---|
| Fosaprepitant Regimen | EXPERIMENTAL | On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, \~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) \~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO \~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO \~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone. |
| Control Regimen | ACTIVE_COMPARATOR | On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, \~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO \~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO \~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone. |
| 1 | EXPERIMENTAL | Arm 1: study medication |
| 2 | ACTIVE_COMPARATOR | Arm 2: Active comparator |
| Name | Type | Description |
|---|---|---|
| Fosaprepitant dimeglumine | DRUG | - |
| Fosaprepitant Placebo | DRUG | - |
| Dexamethasone | DRUG | - |
| Ondansetron | DRUG | - |
| Dexamethasone Placebo | DRUG | - |
| Ondansetron Placebo | DRUG | - |
| Rescue Therapy | DRUG | - |
| Comparator: fosaprepitant dimeglumine | DRUG | single IV dose of 150 mg of fosaprepitant dimeglumine on Day 1. |
| Comparator: Aprepitant | DRUG | Aprepitant 3-day dosing oral regimen (125 mg on Day 1 followed by 80 mg on Days 2 and 3). |
Inclusion Criteria: * Has a histologically or cytologically confirmed malignant disease * Is naive to moderately and highly emetogenic chemotherapy * Is scheduled to receive a single IV dose of one or more MEC agents on Day 1, except for the combination of anthracycline and cyclophosphamide * Has a...