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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
The current recommended guideline for patients receiving moderately emetogenic chemotherapy (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been observed. Hence, there is clearly a need for more effective prevention of CINV in patients receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to these symptoms. Therefore the investigators designed a study with the objective to evaluate if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in ovarian carcinoma patients treated with taxane/carboplatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aprepitant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aprepitant/Ramosetron/Dexamethasone | Drug | Aprepitant: The first day, one 125 mg capsule will be administered per oral, 1 hour before chemotherapy. Thereafter one 80 mg capsule will be repeated daily between 8 to 10 a.m. during days 2 to 3. Ramosetron: 0.3 mg i.v. a single dose on day 1, administered over 30 seconds, 30 minutes prior to chemotherapy. Dexamethasone: 20mg diluted in 50ml of 0.9% saline i.v. a single dose on day 1, administered over 30minutes prior to chemotherapy (taxane). Because all patients are premedicated with dexamethasone 20 mg before taxane administration, the dose of dexamethasone can not be reduced to 12 mg. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy. | Complete Response is defined as No vomiting with no rescue therapy. These response criteria will be applied to the following time periods: Overall: from 0 (chemotherapy initiation) to the morning of day 6, Acute: 0 to 24 hours following the initiation of chemotherapy, Delayed: 25 hours to the morning of day 6(D6). | 120 hours |
| Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen | 120 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With no Vomiting During the 120 Hour Following Initiation of Chemotherapy | 120 hours | |
| Time to First Vomiting Episode or Use of Rescue Medication | 120 hours |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Duk Soo Bae, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24337621 | Derived | Choi CH, Kim MK, Park JY, Yoon A, Kim HJ, Lee YY, Kim TJ, Lee JW, Kim BG, Bae DS. Safety and efficacy of aprepitant, ramosetron, and dexamethasone for chemotherapy-induced nausea and vomiting in patients with ovarian cancer treated with paclitaxel/carboplatin. Support Care Cancer. 2014 May;22(5):1181-7. doi: 10.1007/s00520-013-2070-6. Epub 2013 Dec 12. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Aprepitant | Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aprepitant | Aprepitant is a selective, high-affinity NK1 receptor antagonist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy. | Complete Response is defined as No vomiting with no rescue therapy. These response criteria will be applied to the following time periods: Overall: from 0 (chemotherapy initiation) to the morning of day 6, Acute: 0 to 24 hours following the initiation of chemotherapy, Delayed: 25 hours to the morning of day 6(D6). | Posted | Number | Percentage of Participants | 120 hours |
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| Primary | Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen | Not Posted | 120 hours | |||||||||||||||||||||||||||||||||
| Secondary | Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With no Vomiting During the 120 Hour Following Initiation of Chemotherapy | Not Posted | 120 hours | |||||||||||||||||||||||||||||||||
| Secondary | Time to First Vomiting Episode or Use of Rescue Medication | Not Posted | 120 hours |
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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 | Aprepitant is a selective, high-affinity NK1 receptor antagonist | 2 | 89 | 35 | 89 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenic fever | Blood and lymphatic system disorders |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders |
| |||
| fatigue | General disorders |
| |||
| headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pf Duk-Soo Bae | Samsung Medical Center | 82-2-3410-3519 | huna0@naver.com |
| ID | Term |
|---|---|
| D014839 | Vomiting |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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