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| ID | Type | Description | Link |
|---|---|---|---|
| 2009_626 |
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This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant (MK-0869) | Experimental |
| |
| Standard Therapy | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aprepitant | Drug | Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1 | Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy. | 0 to 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Complete Response in the Acute Phase of Cycle 1 | Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy. | 0 to 24 hours |
| Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1 |
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Inclusion Criteria:
Cycle 1:
Cycle 2 (optional):
appropriate by the investigator and will not pose unwarranted risk to the patient.
study procedures.
dose is still no less than 70 mg/m^2.
Exclusion Criteria:
Cycles 1 & 2:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24276953 | Result | Hu Z, Cheng Y, Zhang H, Zhou C, Han B, Zhang Y, Huang C, Chang J, Song X, Liang J, Liang H, Bai C, Yu S, Chen J, Wang J, Pan H, Chitkara DK, Hille DA, Zhang L. Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial. Support Care Cancer. 2014 Apr;22(4):979-87. doi: 10.1007/s00520-013-2043-9. Epub 2013 Nov 26. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aprepitant (MK-0869) | Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Cycle 1 |
|
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| Comparator: Placebo to aprepitant | Drug | Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg |
|
| dexamethasone | Drug | Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg |
|
| granisetron | Drug | Day 1: IV granisetron 3 mg prior to administration of cisplatin |
|
| dexamethasone | Drug | Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg |
|
Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy. |
| 25 to 120 hours |
| Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1 | Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy. No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy). | 0 to 120 hours |
| Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1 | Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy. | 0 to 24 hours |
| Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1 | Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy | 25 to 120 hours |
| Proportion of Participants With No Impact on Daily Life in Cycle 1 | The Functional Living Index-Emesis is a self-administered, validated emesis & nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. "No impact of chemotherapy-induced nausea & vomiting (CINV) on daily life" was defined as an average item score of >6 on the 7-point scale (i.e., >108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 & 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best). | 0 to 120 hours |
| Time to First Vomiting Episode in Cycle 1 | Time from administration of chemotherapy to first vomiting episode. | 0 to 120 hours |
| Placebo |
Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Cycle 2 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aprepitant (MK-0869) | Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg |
| BG001 | Placebo | Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1 | Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy. | Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis. | Posted | Number | Proportion of participants | 0 to 120 hours |
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| Secondary | Proportion of Participants With Complete Response in the Acute Phase of Cycle 1 | Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy. | Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis. | Posted | Number | Proportion of participants | 0 to 24 hours |
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| Secondary | Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1 | Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy. | Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis. | Posted | Number | Proportion of participants | 25 to 120 hours |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1 | Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy. No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy). | Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis. | Posted | Number | Proportion of participants | 0 to 120 hours |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1 | Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy. | Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis. | Posted | Number | Proportion of participants | 0 to 24 hours |
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| Secondary | Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1 | Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy | Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis. | Posted | Number | Proportion of participants | 25 to 120 hours |
|
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| Secondary | Proportion of Participants With No Impact on Daily Life in Cycle 1 | The Functional Living Index-Emesis is a self-administered, validated emesis & nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. "No impact of chemotherapy-induced nausea & vomiting (CINV) on daily life" was defined as an average item score of >6 on the 7-point scale (i.e., >108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 & 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best). | Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis. | Posted | Number | Proportion of participants | 0 to 120 hours |
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| Secondary | Time to First Vomiting Episode in Cycle 1 | Time from administration of chemotherapy to first vomiting episode. | Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis. | Posted | Mean | Standard Error | Hours | 0 to 120 hours |
|
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The All Patients as Treated (APaT) population were used for the analysis of
safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aprepitant (MK-0869), Cycle 1 & Cycle 2 | Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg | 5 | 205 | 123 | 205 | ||
| EG001 | Placebo, Cycle 1 & Cycle 2 | Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin | 2 | 210 | 124 | 210 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Death | General disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Neutrophil count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| 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 |
| D003907 | Dexamethasone |
| D017829 | Granisetron |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D007191 | Indazoles |
| D011720 | Pyrazoles |
| D001393 | Azoles |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Lost to Follow-up |
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| Physician Decision |
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| Progressive Disease |
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