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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00337727 | Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV)(0869-130)(COMPLETED) | PHASE3 | COMPLETED | 848 | — | — | Jan 1, 2007 | Nov 19, 2008 | Jun 2, 2017 | - | — |
| NCT00945321 | A Study to Assess the Bioequivalence of Aprepitant and Fosaprepitant and the Effect of Food on Aprepitant Bioavailability (0869-165) | PHASE1 | COMPLETED | 42 | — | — | Feb 1, 2009 | Mar 1, 2009 | Jan 28, 2015 | - | — |
The number of patients who reported No Vomiting in the overall phase in Cycle 1
| Arm | Type | Description |
|---|---|---|
| 1 | OTHER | Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours. |
| 2 | OTHER | Arm 2: Day 1: Aprepitant 125 mg Pbo capsule; Ondansetron 8 mg capsule prior to chemotherapy and 8 mg capsule 12 hours after first dose; Dexamethasone 20 mg tablets. Day 2: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours; Day 3: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours. 3 Day treatment period Optional cycle 2 is being offered to patients. Optional cycle 2 will substitute aprepitant with fosaprepitant dimeglumine 115 mg or Pbo on day 1. All other dosing regimen will remain the same as cycle 1. |
| 3 | EXPERIMENTAL | fosaprepitant 150 mg |
| 4 | EXPERIMENTAL | aprepitant with food |
| Name | Type | Description |
|---|---|---|
| aprepitant | DRUG | aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period. |
| Comparator: ondansetron | DRUG | Ondansetron 8 mg capsule Three day treatment period. |
| Comparator: dexamethasone | DRUG | dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period. |
| Comparator: fosaprepitant dimeglumine | DRUG | fosaprepitant dimeglumine 115 mg |
| Comparator; Placebo (unspecified) | DRUG | dexamethasone 12mg Pbo tablets. |
| aprepitant 165 mg | DRUG | Single dose of aprepitant 165 mg tablet in the fasted state during treatment period 1,2, or 3. |
| Comparator: aprepitant 185 mg | DRUG | Single dose of aprepitant 185 mg tablet in the fasted state during treatment period 1, 2, or 3. |
| Comparator: fosaprepitant 150 mg | DRUG | Single dose of fosaprepitant 150 mg intravenous infusion in the fasted state during treatment period 1,2, or 3. |
| Comparator: aprepitant with food | DRUG | Single dose of aprepitant 165 mg or 185 mg tablet in the fed state during treatment period 4. |
Inclusion Criteria: * Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1 * Karnofsky score of 60 or greater Exclusion Criteria: * Patient is sche...