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| ID | Type | Description | Link |
|---|---|---|---|
| 2006_016 | Other Identifier | protocol number |
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The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aprepitant | Drug | aprepitant 125 mg capsule; aprepitant 80 mg capsule Three day treatment period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Reported No Vomiting | The number of patients who reported No Vomiting in the overall phase in Cycle 1 | Overall phase (0-120 hours post initiation of MEC) in Cycle 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Reported Complete Response | The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1. | Overall phase (0-120 hours post initiation of MEC) 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 |
|---|---|---|---|
| 19568773 | Result | Rapoport BL, Jordan K, Boice JA, Taylor A, Brown C, Hardwick JS, Carides A, Webb T, Schmoll HJ. Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: a randomized, double-blind study. Support Care Cancer. 2010 Apr;18(4):423-31. doi: 10.1007/s00520-009-0680-9. Epub 2009 Jul 1. | |
| 24911369 |
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Cancer patients naïve to both moderately and highly emetogenic chemotherapy (MEC and HEC, respectively) scheduled to receive an initial course of MEC for confirmed malignant disease. The study focused on patients receiving an initial cycle of MEC (Cycle 1).
This study was conducted at 58 investigative sites worldwide. The first patient entered the study on 16-Jan-
2007 and the last patient's last visit was on 28-Oct-2008.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aprepitant Regimen | Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3. |
| FG001 | Standard Regimen |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Comparator: ondansetron | Drug | Ondansetron 8 mg capsule Three day treatment period. |
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| Comparator: dexamethasone | Drug | dexamethasone 12 mg tablets; 20 mg tablets Three day treatment period. |
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| Comparator: fosaprepitant dimeglumine | Drug | fosaprepitant dimeglumine 115 mg |
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| Comparator; Placebo (unspecified) | Drug | dexamethasone 12mg Pbo tablets. |
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| Comparator; Placebo (unspecified) | Drug | Aprepitant 80 mg & 125 mg Pbo capsules. |
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| Derived |
| Rapoport BL. Efficacy of a triple antiemetic regimen with aprepitant for the prevention of chemotherapy-induced nausea and vomiting: effects of gender, age, and region. Curr Med Res Opin. 2014 Sep;30(9):1875-81. doi: 10.1185/03007995.2014.925866. Epub 2014 Jun 12. |
| 23062719 | Derived | Aapro MS, Schmoll HJ, Jahn F, Carides AD, Webb RT. Review of the efficacy of aprepitant for the prevention of chemotherapy-induced nausea and vomiting in a range of tumor types. Cancer Treat Rev. 2013 Feb;39(1):113-7. doi: 10.1016/j.ctrv.2012.09.002. Epub 2012 Oct 11. |
Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aprepitant Regimen | Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3. |
| BG001 | Standard Regimen | Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| History of Motion Sickness | Number | Participants |
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| History of Vomiting with Pregnancy | Measure is specific to the female study population. | 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Patients Who Reported No Vomiting | The number of patients who reported No Vomiting in the overall phase in Cycle 1 | FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderately Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed at least one post treatment efficacy assessment. | Posted | Number | Participants | Overall phase (0-120 hours post initiation of MEC) in Cycle 1. |
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| Secondary | Number of Patients Who Reported Complete Response | The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1. | FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received MEC, (2) took a dose of study drug, and (3) completed at least one post treatment efficacy assessment. | Posted | Number | Participants | Overall phase (0-120 hours post initiation of MEC) in Cycle 1 |
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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 Regimen | Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3. | 12 | 430 | 265 | 430 | ||
| EG001 | Standard Regimen | Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3. | 20 | 418 | 270 | 418 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | MedDRA 11.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Ileitis | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Mucosal Inflammation | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Abdominal Infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Abscess Limb | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Herpes Zoster | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Lobar pneumonia | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Lung Infection | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Pyelonephritis | Infections and infestations | MedDRA 11.1 | Non-systematic Assessment |
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| Compression Fracture | Injury, poisoning and procedural complications | MedDRA 11.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.1 | Non-systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Vaginal Haemorrhage | Reproductive system and breast disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Arterial Occlusive Disease | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Peripheral Ischemia | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Superior Vena Cava Occlusion | Vascular disorders | MedDRA 11.1 | Non-systematic Assessment | Superior Vena Cava Occlusion |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Asthenia | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Mucosal Inflammation | General disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Neuropathy Peripheral | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 11.1 | Non-systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 11.1 | Non-systematic Assessment |
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Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| 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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| Male |
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| Asian |
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| Black |
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| Multi-racial |
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| Other |
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| No |
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| No Data - Assessment Not Completed |
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| No |
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| Not Applicable- Male Patients |
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