Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-01-14 @ 2:59 AM
Study NCT ID:
NCT01046461
Status:
UNKNOWN
Last Update Posted:
2012-02-17
First Post:
2010-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2012-11-08', 'releaseDate': '2012-10-11'}], 'estimatedResultsFirstSubmitDate': '2012-10-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C071315', 'term': 'ramosetron'}, {'id': 'D000077608', 'term': 'Aprepitant'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-02-16', 'studyFirstSubmitDate': '2010-01-08', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response (CR) rate of RAD for the prevention of chemotherapy induced nausea vomiting (CINV) during overall phase (form 1 to 5 days) (overall phase is defined as acute and delayed phase)', 'timeFrame': 'from chemotherapy day 1 to day 5'}], 'secondaryOutcomes': [{'measure': 'CR rate of RAD for the prevention of acute and delayed phase of CINV (from 0 to 24 hours /from 2 to 5 days)', 'timeFrame': 'until 1 month after chemotherapy'}, {'measure': 'Severity of nausea', 'timeFrame': 'until 1 month after chemotherapy'}, {'measure': 'Time to first occurrence of vomiting', 'timeFrame': 'until 1 month after chemotherapy'}, {'measure': 'Adverse events reported using CTCAE v3.0', 'timeFrame': 'until 1 month after chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ramosetron', 'aprepitant', 'dexamethasone', 'cancer', 'chemotherapy', 'antiemetics', 'cisplatin', 'nausea', 'vomiting', 'high dose cisplatin'], 'conditions': ['Solid Tumour', 'Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis. Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and tolerability and a longer duration of effect than granisetron in preventing acute vomiting in patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in 84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase emesis was less than 60%.\n\nAprepitant is a selective, high-affinity NK1 receptor antagonist. Adding aprepitant to 5-HT3 receptor antagonists and steroid improve CR rate of not only chemotherapy induced acute emesis and but also delayed emesis by 11-14 and 20 percentage points, respectively.\n\nBut until now, there was no information that which 5-HT3 receptor antagonists is the best partner for aprepitant. Therefore, we initiated a prospective, open-label, phase II study to assess the efficacy and tolerability of a combination of ramosetron, aprepitant and dexamethasone (RAD) in the prevention of cisplatin based CINV in chemotherapy-naïve patients with solid cancer', 'detailedDescription': 'Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis. Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and tolerability and a longer duration of effect than granisetron in preventing acute vomiting in patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented in 84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase emesis was less than 60%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 -75 years, both sex\n* ECOG performance status 0-2\n* Histologically proven solid cancer, chemotherapy-naïve patient\n* Planed to receive cisplatin (≥ 50mg/m2) based, single day chemotherapy,\n* No nausea or vomiting within 72 hours prior to chemotherapy\n* Serum Cr \\< 2.5 mg/dl, or calculated CCr ≥ 50 ml/min\n* Serum total bilirubin \\< 2 mg/dl, AST/ALT \\< 3 times the upper normal limit , ALP \\< 5 times the upper normal limit\n* Absolute neutrophil count ≥ 1,500/μL, platelet ≥ 100,000/μL\n* Expected life duration ≥ 3 months\n* Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital\n\nExclusion Criteria:\n\n* Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, active gastric or duodenal ulcers, or pregnancy or breast-feeding\n* Patients who should take steroid, antiemetics, pimozide, terfenadine, astemizole, cisapride, rifampin, carbamazepine, phenytoin, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir or nelfinavir for the treatment of other diseases\n* Patients taking any medicine, which could affect study results, within 1 week before chemotherapy (or taking anti-emetics within 48 hours before chemotherapy). Prior to beginning chemotherapy, single-agent benzodiazepines as hypnotic is allowed, but it can't be receiving during day 1-6 of 1st chemotherapy cycle.\n* Patients with symptomatic brain metastasis\n* Patients with GI obstruction or other diseases that could provoke nausea and vomiting\n* Patients receiving RT on brain, abdomen or pelvis within 2 weeks before chemotherapy\n* Patients who cannot understand informed consent or express his/her condition\n* Patients who cannot swallow drugs\n* Patients who have known allergy or severe side effect on study drugs"}, 'identificationModule': {'nctId': 'NCT01046461', 'acronym': 'RAD', 'briefTitle': 'Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hallym University Medical Center'}, 'officialTitle': 'A Phase II Study to Evaluate the Efficacy and Tolerability of Ramosetron, Aprepitant and Dexamethasone (RAD) in Preventing Cisplatin-induced Nausea and Vomiting in Chemotherapy-naïve Patients With Solid Cancer', 'orgStudyIdInfo': {'id': 'RAD1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ramosetron, Aprepitant, Dexamethasone', 'interventionNames': ['Drug: Ramosetron, Aprepitant, Dexamethasone']}], 'interventions': [{'name': 'Ramosetron, Aprepitant, Dexamethasone', 'type': 'DRUG', 'otherNames': ['Nasea', 'Emend'], 'description': 'Day 1:\n\nAprepitant 125 mg PO, 1 hour before chemotherapy Ramosetron 0.6 mg IV, 30 min before chemotherapy Dexamethasone 12 mg PO, 30 min before chemotherapy\n\nDay 2 - 3:\n\nAprepitant 80 mg PO. in the morning Dexamethasone 8 mg PO. in the morning\n\nDay 4 Dexamethasone 8 mg PO. in the morning', 'armGroupLabels': ['Ramosetron, Aprepitant, Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '431-070', 'city': 'Anyang-si', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Hallym University Sacred Heart Hospital', 'geoPoint': {'lat': 37.3925, 'lon': 126.92694}}], 'overallOfficials': [{'name': 'Hyo Jung Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hallym University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hallym University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2012-10-11', 'type': 'RELEASE'}, {'date': '2012-11-08', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hallym University Medical Center'}}}}