Clinical Trial Results:
ONO-7436 Phase III Study–A multicenter, open-label, uncontrolled study for the prevention of chemotherapy-induced nausea and vomiting
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Summary
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EudraCT number |
2018-000662-11 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
17 Feb 2011
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Results information
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Results version number |
v1(current) |
This version publication date |
15 Jul 2018
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First version publication date |
15 Jul 2018
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
0869-206
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Other trial identifiers |
Merck Protocol Number: MK-0869-206, Ono Pharmaceutical Co., Ltd. Protocol Number: ONO 7436-03 | ||
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Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
17 Feb 2011
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
17 Feb 2011
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The objective of the study was to evaluate the safety, efficacy, and pharmacokinetics of aprepitant (MK-0869/ONO-7436) for the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric Japanese participants 12-18 years of age with malignant tumor who are scheduled to receive chemotherapy including any of cisplatin, cyclophosphamide, or carboplatin.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Sep 2009
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Japan: 22
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Worldwide total number of subjects |
22
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
20
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Adults (18-64 years) |
2
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||
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Pre-assignment
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Screening details |
Japanese participants aged 12-18 years with malignant tumor that is confirmed by cytological or histological examination, who were scheduled to receive chemotherapy including any of cisplatin, cyclophosphamide, or carboplatin. | ||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||
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Arms
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Arm title
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Aprepitant 125/80 | ||||||
Arm description |
Participants received aprepitant 125 mg administered orally (PO) plus dexamethasone 4 mg intravenously (IV) and Granisteron 40 mcg/kg administered IV on Day 1 prior to chemotherapy. On Days 2 and 3, participants received aprepitant 80 mg administered PO and dexamethasone 4 mg IV. Granisteron 40 mcg/kg was administered IV on chemotherapy days if highly or moderately emetogenic therapy was administered on Days 1-5. | ||||||
Arm type |
Experimental | ||||||
Investigational medicinal product name |
aprepitant
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Investigational medicinal product code |
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Other name |
EMEND®
MK-0869
ONO-7436
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Pharmaceutical forms |
Capsule
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Routes of administration |
Oral use
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Dosage and administration details |
Aprepitant 125 mg was administered orally once a day (QD) on Day 1 prior to chemotherapy followed by 80 mg administered orally QD on Days 2 and 3.
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Investigational medicinal product name |
Dexamethasone
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Dexamethasone 4 mg was administered intravenously (IV) once a day on Days 1, 2 and 3 approximately 30 minutes prior to the start of chemotherapy.
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Investigational medicinal product name |
Granisteron
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intravenous use
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Dosage and administration details |
Granisteron 40 mcg/kg was administered on Day 1 approximately 30 minutes prior to the start of chemotherapy. In addition if highly or moderately emetogenic therapy was administered on Days 1-5 granisetron 40 mcg/kg was also administered IV on chemotherapy days.
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Baseline characteristics reporting groups
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Reporting group title |
Aprepitant 125/80
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Reporting group description |
Participants received aprepitant 125 mg administered orally (PO) plus dexamethasone 4 mg intravenously (IV) and Granisteron 40 mcg/kg administered IV on Day 1 prior to chemotherapy. On Days 2 and 3, participants received aprepitant 80 mg administered PO and dexamethasone 4 mg IV. Granisteron 40 mcg/kg was administered IV on chemotherapy days if highly or moderately emetogenic therapy was administered on Days 1-5. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Aprepitant 125/80
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Reporting group description |
Participants received aprepitant 125 mg administered orally (PO) plus dexamethasone 4 mg intravenously (IV) and Granisteron 40 mcg/kg administered IV on Day 1 prior to chemotherapy. On Days 2 and 3, participants received aprepitant 80 mg administered PO and dexamethasone 4 mg IV. Granisteron 40 mcg/kg was administered IV on chemotherapy days if highly or moderately emetogenic therapy was administered on Days 1-5. | ||
Subject analysis set title |
Aprepitant 125/80 Efficacy Cohort
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
The efficacy analysis was in all participants who completed at least 1 dose of study drug.
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Subject analysis set title |
Aprepitant 125/80 Safety Cohort
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The safety analysis was in all participants who completed at least 1 dose of study drug.
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Subject analysis set title |
Aprepitant 125/80 PK Cohort
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
The PK analysis was in all participants who completed at least 1 dose of study drug according to protocol and had adequate data available for the PK parameter being analyzed.
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End point title |
Percentage of Participants Who Experience a Complete Response During the Overall Phase (0 to 120 hours post initiation of chemotherapy) [1] | ||||||||
End point description |
Complete response was defined as no vomiting and no use of rescue medication following the initiation of emetogenic chemotherapy. A vomiting episode was specified as one or more continuous vomits (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of vomiting and retching for at least one minute. The date, time, and number of vomiting episodes were recorded by participants in diaries at the time of occurrence. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants with vomiting and no use of rescue medication in the overall phase, defined as the time period of 0 to120 hours post initiation of chemotherapy, was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Primary
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End point timeframe |
0 to 120 hours post initiation of chemotherapy
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Who Experience a Complete Response During the Acute Phase (0 to 24 hours post initiation of chemotherapy) [2] | ||||||||
End point description |
Complete response was defined as no vomiting and no use of rescue medication following the initiation of emetogenic chemotherapy. A vomiting episode was specified as one or more continuous vomits (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of vomiting and retching for at least one minute. The date, time, and number of vomiting episodes were recorded by participants in diaries at the time of occurrence. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants with vomiting and no use of rescue medication in the acute phase, defined as the time period of 0 to 24 hours post initiation of chemotherapy, was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Primary
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End point timeframe |
0 to 24 hours post initiation of chemotherapy
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Who Experience a Complete Response During the Delayed Phase (>24 to 120 hours post initiation of chemotherapy) [3] | ||||||||
End point description |
Complete response was defined as no vomiting and no use of rescue medication following the initiation of emetogenic chemotherapy. A vomiting episode was specified as one or more continuous vomits (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of vomiting and retching for at least one minute. The date, time, and number of vomiting episodes were recorded by participants in diaries at the time of occurrence. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants with vomiting and no use of rescue medication in the delayed phase, defined as the time period of >24 to120 hours post initiation of chemotherapy, was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Primary
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End point timeframe |
>24 to 120 hours post initiation of chemotherapy
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Who Experience One or More Drug-related AE [4] | ||||||||
End point description |
A drug-related AE was an AE that was determined by the investigator to be related to the treatment. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants who experienced at least one drug-related AE was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Primary
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End point timeframe |
up to 15 days after the start of study treatment
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Who Discontinued Study Drug Due to a Drug-related AE [5] | ||||||||
End point description |
The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants who discontinued study treatment due to a drug-related AE was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Primary
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End point timeframe |
up to 5 days
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses were planned for this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Who Experience Total Control During the Overall Phase (0 to 120 hours post initiation of chemotherapy) | ||||||||
End point description |
Total control was defined as no vomiting, no nausea, and no use of rescue medication following the initiation of emetogenic chemotherapy. A vomiting episode was specified as one or more continuous vomits (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes were separated by the absence of vomiting and retching for at least one minute. The date, time, and number of vomiting episodes were recorded by participants in diaries at the time of occurrence. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants with no vomiting, no nausea, and no use of rescue medication in the overall phase, defined as the time period of 0 to120 hours post initiation of chemotherapy, was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Secondary
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End point timeframe |
0 to 120 hours post initiation of chemotherapy
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants with No Vomiting During the Overall Phase (0 to 120 hours post initiation of chemotherapy) | ||||||||
End point description |
Vomiting was assessed, regardless of rescue medicine use for treatment of emergent nausea and vomiting, following chemotherapy. A vomiting episode was specified as one or more continuous vomits (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Vomiting episodes were separated by the absence of vomiting/retching for ≥1 minute. The date, time, and number of vomiting episodes were recorded by participants in diaries at the time of occurrence. Rescue medication was permitted for emergent nausea or vomiting but not as preventive medication. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants with no vomiting episodes in the overall phase, defined as the time period of 0-120 hours post initiation of chemotherapy, was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Secondary
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End point timeframe |
0 to 120 hours post initiation of chemotherapy
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants with No Vomiting During the Acute Phase (0 to 24 hours post initiation of chemotherapy) | ||||||||
End point description |
Vomiting was assessed, regardless of rescue medicine use for treatment of emergent nausea and vomiting, following chemotherapy. A vomiting episode was specified as one or more continuous vomits (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Vomiting episodes were separated by the absence of vomiting/retching for ≥1 minute. The date, time, and number of vomiting episodes were recorded by participants in diaries at the time of occurrence. Rescue medication was permitted for emergent nausea or vomiting but not as preventive medication. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants with no vomiting episodes in the acute phase, defined as the time period of 0-24 hours post initiation of chemotherapy, was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Secondary
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End point timeframe |
0 to 24 hours post initiation of chemotherapy
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants with No Vomiting During the Delayed Phase (>24 to 120 hours post initiation of chemotherapy) | ||||||||
End point description |
Vomiting was assessed, regardless of rescue medicine use for treatment of emergent nausea and vomiting, following chemotherapy. A vomiting episode was specified as one or more continuous vomits (expulsion of stomach contents through the mouth) or retching/dry heaves (an attempt to vomit that is not productive of stomach contents). Vomiting episodes were separated by the absence of vomiting/retching for ≥1 minute. The date, time, and number of vomiting episodes were recorded by participants in diaries at the time of occurrence. Rescue medication was permitted for emergent nausea or vomiting but not as preventive medication. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants with no vomiting episodes in the delayed phase, defined as the time period of >24-120 hours post initiation of chemotherapy, was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Secondary
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End point timeframe |
>24 to 120 hours post initiation of chemotherapy
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants with No Use of Rescue Therapy During the Overall Phase (0 to 120 hours post initiation of chemotherapy) | ||||||||
End point description |
Rescue therapy was allowed for treatment of emergent nausea and vomiting following the initiation of emetogenic chemotherapy but was restricted to permitted medications only. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants with no use of rescue therapy in the overall phase, defined as the time period of 0 to 120 hours post initiation of chemotherapy, was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Secondary
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End point timeframe |
0 to 120 hours post initiation of chemotherapy
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants with No Use of Rescue Therapy During the Acute Phase (0 to 24 hours post initiation of chemotherapy) | ||||||||
End point description |
Rescue therapy was allowed for treatment of emergent nausea and vomiting following the initiation of emetogenic chemotherapy but was restricted to permitted medications only. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants with no use of rescue therapy in the acute phase, defined as the time period of 0 to 24 hours post initiation of chemotherapy, was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Secondary
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End point timeframe |
0 to 24 hours post initiation of chemotherapy
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants with No Use of Rescue Therapy During the Delayed Phase (>24 to 120 hours post initiation of chemotherapy) | ||||||||
End point description |
Rescue therapy was allowed for treatment of emergent nausea and vomiting following the initiation of emetogenic chemotherapy but was restricted to permitted medications only. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants with no use of rescue therapy in the delayed phase, defined as the time period of >24 to 120 hours post initiation of chemotherapy, was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Secondary
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End point timeframe |
>24 to 120 hours post initiation of chemotherapy
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants with No Nausea During the Overall Phase (0 to 120 hours post initiation of chemotherapy) | ||||||||
End point description |
In this study, nausea was defined as significant nausea that may interfere with usual daily activities. Nausea was determined by an investigator inquiry. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants with no nausea in the overall phase, defined as the time period of 0 to 120 hours post initiation of chemotherapy, was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Secondary
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End point timeframe |
0 to 120 hours post initiation of chemotherapy
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants Who Experience One or More Adverse Events (AE) | ||||||||
End point description |
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship to the treatment. An AE was any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants who experienced at least one AE was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Secondary
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End point timeframe |
up to 15 days after the start of study treatment
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| No statistical analyses for this end point | |||||||||
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End point title |
Observed Maximum Concentration (Cmax) of Aprepitant | ||||||||
End point description |
Blood samples were obtained at specified time points for the pharmacokinetic (PK) analysis of Cmax of aprepitant. Aprepitant concentrations were calculated using non-compartment analysis methods. The endpoint analysis was in all participants who completed at least 1 dose of study drug according to protocol and had adequate data available for the PK parameter being analyzed. The Cmax of aprepitant after oral administration is presented.
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End point type |
Secondary
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End point timeframe |
Day 1: 1, 2, 3, 5, 9, and 11 hours postdose; Day 2: predose; Days 3 and 4: predose and 24 hours postdose
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| No statistical analyses for this end point | |||||||||
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End point title |
Time to Maximum Concentration (Tmax) of Aprepitant | ||||||||
End point description |
Blood samples were obtained at specified time points for the PK analysis of Tmax of aprepitant. Aprepitant concentrations were calculated using non-compartment analysis methods. The endpoint analysis was in all participants who completed at least 1 dose of study drug according to protocol and had adequate data available for the PK parameter being analyzed. The Tmax of aprepitant after oral administration is presented.
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End point type |
Secondary
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End point timeframe |
Day 1: 1, 2, 3, 5, 9, and 11 hours postdose; Day 2: predose; Days 3 and 4: predose and 24 hours postdose
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| No statistical analyses for this end point | |||||||||
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End point title |
Area Under the Concentration-time Curve of Aprepitant From Time 0 to 24 Hours (AUC 0-24h) | ||||||||
End point description |
Blood samples were obtained at specified time points for the PK analysis of AUC 0-24h of aprepitant. Aprepitant concentrations were calculated using non-compartment analysis methods. The endpoint analysis was in all participants who completed at least 1 dose of study drug according to protocol and had adequate data available for the PK parameter being analyzed. The AUC 0-24h of aprepitant after oral administration is presented.
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End point type |
Secondary
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End point timeframe |
Day 1: 1, 2, 3, 5, 9, and 11 hours postdose; Day 2: predose; Days 3 and 4: predose and 24 hours postdose
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| No statistical analyses for this end point | |||||||||
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End point title |
Plasma Concentration of Aprepitant After 24 Hours (C24h) | ||||||||
End point description |
Blood samples were obtained at specified time points for the PK analysis of C24h of aprepitant. Aprepitant concentrations were calculated using non-compartment analysis methods. The endpoint analysis was in all participants who completed at least 1 dose of study drug according to protocol and had adequate data available for the PK parameter being analyzed. The C24h of aprepitant after oral administration is presented.
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End point type |
Secondary
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End point timeframe |
Day 1: 1, 2, 3, 5, 9, and 11 hours postdose; Day 2: predose; Days 3 and 4: predose and 24 hours postdose
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| No statistical analyses for this end point | |||||||||
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End point title |
Plasma Concentration of Aprepitant After 48 Hours (C48h) | ||||||||
End point description |
Blood samples were obtained at specified time points for the PK analysis of C48h of aprepitant. Aprepitant concentrations were calculated using non-compartment analysis methods. The endpoint analysis was in all participants who completed at least 1 dose of study drug according to protocol and had adequate data available for the PK parameter being analyzed. The C48h of aprepitant after oral administration is presented.
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End point type |
Secondary
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End point timeframe |
Day 1: 1, 2, 3, 5, 9, and 11 hours postdose; Day 2: predose; Days 3 and 4: predose and 24 hours postdose
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| No statistical analyses for this end point | |||||||||
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End point title |
Plasma Concentration of Aprepitant After 72 Hours (C72h) | ||||||||
End point description |
Blood samples were obtained at specified time points for the PK analysis of C72h of aprepitant. Aprepitant concentrations were calculated using non-compartment analysis methods. The endpoint analysis was in all participants who completed at least 1 dose of study drug according to protocol and had adequate data available for the PK parameter being analyzed. The C72h of aprepitant after oral administration is presented.
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End point type |
Secondary
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End point timeframe |
Day 1: 1, 2, 3, 5, 9, and 11 hours postdose; Day 2: predose; Days 3 and 4: predose and 24 hours postdose
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End point title |
Percentage of Participants Who Discontinued Study Drug Due to an AE | ||||||||
End point description |
The endpoint analysis was in all participants who completed at least 1 dose of study drug. The percentage of participants who discontinued study treatment due to an AE was calculated and presented with two-sided 95% confidence intervals calculated by the Clopper-Pearson exact method.
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End point type |
Secondary
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End point timeframe |
up to 5 days
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
up to 15 days after the start of study treatment
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Adverse event reporting additional description |
The safety population included all participants that received at least 1 dose of aprepitant.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
14.0
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Reporting groups
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Reporting group title |
Aprepitant 125/80 Safety Cohort
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Reporting group description |
Participants received aprepitant (MK-0869/ONO -7436) 125 mg administered orally (PO) plus dexamethasone 4 mg intravenously (IV) and Granisteron 40 mcg/kg administered IV on Day 1 prior to chemotherapy. On Days 2 and 3, participants received aprepitant (MK-0869/ONO -7436) 80 mg administered PO and dexamethasone 4 mg IV. Granisteron 40 mcg/kg was administered IV on chemotherapy days if highly or moderately emetogenic therapy was administered on further days. The safety analysis was in all participants who completed at least 1 dose of study drug. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
