Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:47 AM
Study NCT ID:
NCT05199818
Status:
UNKNOWN
Last Update Posted:
2023-01-20
First Post:
2021-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077924', 'term': 'Palonosetron'}], 'ancestors': [{'id': 'D011812', 'term': 'Quinuclidines'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 328}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2021-12-15', 'studyFirstSubmitQcDate': '2022-01-06', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete response', 'timeFrame': 'During the first 24 hours after chemotherapy', 'description': 'No emetic episode and no rescue medication'}], 'secondaryOutcomes': [{'measure': 'Complete response', 'timeFrame': '24-120 hours post chemotherapy', 'description': 'No emetic episode and no rescue medication'}, {'measure': 'Absence of nausea', 'timeFrame': 'up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy', 'description': 'Absence of nausea based on daily patient questionnaire (yes or no) and no emetic episode or rescue medication'}, {'measure': 'Complete response', 'timeFrame': 'up to 120 hours after chemotherapy', 'description': 'The proportion of patients with complete response'}, {'measure': 'Complete control', 'timeFrame': 'up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy', 'description': 'The proportion of patients with complete control'}, {'measure': 'Number of emetic episodes', 'timeFrame': 'up to 120 hours after chemotherapy', 'description': 'Number of emetic episodes'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chemotherapy-induced Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'The phase 3 study is to compare the efficacy and safety of palonosetron, a long-acting 5-HT3 receptor antagonist, by buccal film delivery compared to IV injection for the prevention of chemotherapy-induced nausea and vomiting. Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.', 'detailedDescription': 'This is a phase 3 randomized, double-blind, parallel group study designed to evaluate the efficacy and safety of palonosetron HCL buccal film versus IV palonosetron for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy (MEC).\n\nSubjects are randomized into two treatment groups, one with the experimental study drug palonosetron in buccal film, the other one with the control treatment using Palonosetron hydrochloride IV injection. Palonosetron PK will be assessed in a subgroup of each treatment group (two sample points, 10% of subjects).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, at least 18-years of age;\n2. Provide written informed consent;\n3. Chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer;\n4. Karnofsky index ≥ 50;\n5. Be scheduled to receive MEC to be administered on Day 1;\n\nExclusion Criteria:\n\n1. Unable to understand or cooperate with study procedure；\n2. Received any investigational drug 30 days prior to study entry；\n3. Used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study；\n4. Enrollment in a previous study with palonosetron；\n5. Seizure disorder requiring anticonvulsant medication;\n6. Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy；\n7. Ongoing vomiting from any organic etiology；\n8. Experienced nausea (moderate to severe or vomiting following any previous chemotherapy)；\n9. Scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapy during the study；\n10. Known contraindication to 5-HT3 antagonist or dexamethasone；\n11. Scheduled to receive bone marrow or stem cell transplant during study;\n12. Symptomatic primary or metastatic CNS malignancy;\n13. Lactating female.'}, 'identificationModule': {'nctId': 'NCT05199818', 'briefTitle': 'Buccal Film vs IV Palonosetron for Prevention of CINV in Cancer Patients Receiving MEC', 'organization': {'class': 'INDUSTRY', 'fullName': 'Xiamen LP Pharmaceutical Co., Ltd'}, 'officialTitle': 'Efficacy and Safety of Palonosetron HCl Buccal Film Versus IV Palonosetron for Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy', 'orgStudyIdInfo': {'id': 'LP-CT-PALO-202101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Palonosetron HCl Buccal Film', 'description': 'Palonosetron HCl Buccal Film 0.5 mg 1 hr before administration of moderately emetogenic chemotherapy and normal saline injection 30 minutes before administration of moderately emetogenic chemotherapy', 'interventionNames': ['Drug: Palonosetron HCl Buccal Film 0.5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Palonosetron IV Injection', 'description': 'Placebo buccal film 1 har before administration of moderately emetogenic chemotherapy and Palonosetron HCl Injection 0.25 mg 30 min before administration of moderately emetogenic chemotherapy', 'interventionNames': ['Drug: IV Palonosetron 0.25 mg']}], 'interventions': [{'name': 'Palonosetron HCl Buccal Film 0.5 mg', 'type': 'DRUG', 'description': 'Palonosetron HCl Buccal Film and IV palonosetron placebo, both administered on Day 1', 'armGroupLabels': ['Palonosetron HCl Buccal Film']}, {'name': 'IV Palonosetron 0.25 mg', 'type': 'DRUG', 'description': 'IV Palonosetron and Palonosetron HCl Buccal Film placebo, both administered on Day 1', 'armGroupLabels': ['Palonosetron IV Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mikhail Shtivelband, MD', 'role': 'CONTACT', 'email': 'barbara.ramirez@ironwood.com', 'phone': '480-821-2838'}], 'facility': 'Ironwood Cancer & Research Centers', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ajit Maniam, Dr', 'role': 'CONTACT'}], 'facility': 'Pacific Cancer Medical Center', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '33805', 'city': 'Lakeland', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Shalini Mulaparthi, MD', 'role': 'CONTACT', 'phone': '863-904-2482'}], 'facility': 'Watson Clinic', 'geoPoint': {'lat': 28.03947, 'lon': -81.9498}}, {'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eloy Roman, MD', 'role': 'CONTACT'}], 'facility': 'Lakes Research', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '34474', 'city': 'Ocala', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Anju Vasudevan, MD', 'role': 'CONTACT', 'phone': '352-732-4032'}], 'facility': 'Florida Cancer Affiliates', 'geoPoint': {'lat': 29.1872, 'lon': -82.14009}}, {'zip': '31405', 'city': 'Savannah', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mark Taylor, MD', 'role': 'CONTACT', 'phone': '912-651-5771'}], 'facility': 'Summit Cancer Care', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60076', 'city': 'Skokie', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Edward H Kaplan, MD', 'role': 'CONTACT'}], 'facility': 'Edward H. Kaplan MD & Associates', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '60077', 'city': 'Skokie', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ira Oliff, MD', 'role': 'CONTACT', 'email': 'jardinico@orchardhr.com', 'phone': '224-534-7580'}], 'facility': 'Orchard Healthcare research, Inc.', 'geoPoint': {'lat': 42.03336, 'lon': -87.73339}}, {'zip': '20817', 'city': 'Bethesda', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ralph Boccia, MD', 'role': 'CONTACT', 'phone': '240-482-0526'}], 'facility': 'American Oncology Partners of Maryland, PA', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '39401', 'city': 'Hattiesburg', 'state': 'Mississippi', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'John Hrom, MD', 'role': 'CONTACT', 'email': 'gloria.simmons@forrestgeneral.com', 'phone': '601-261-1700'}], 'facility': 'Hattiesburg Clinic Hematology/Oncology', 'geoPoint': {'lat': 31.32712, 'lon': -89.29034}}, {'zip': '59102', 'city': 'Billings', 'state': 'Montana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Patrick Cobb, MD', 'role': 'CONTACT', 'email': 'erin.juedeman@sclhealth.org', 'phone': '406-238-6290'}], 'facility': 'St. Vincent Frontier Cancer Center', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '44646', 'city': 'Massillon', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott McGee, MD', 'role': 'CONTACT', 'phone': '330-489-8118'}], 'facility': 'Tri-County Hematology & Oncology Associates', 'geoPoint': {'lat': 40.79672, 'lon': -81.52151}}, {'zip': '17325', 'city': 'Gettysburg', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Satish A Shah, MD', 'role': 'CONTACT', 'phone': '717-334-4033'}], 'facility': 'Gettysburg Cancer Center', 'geoPoint': {'lat': 39.83093, 'lon': -77.2311}}], 'centralContacts': [{'name': 'Matthew H Nieder, Ph.D.', 'role': 'CONTACT', 'email': 'matthew@lppharma.com', 'phone': '415 516-9498'}, {'name': 'Linhui Cai, MS', 'role': 'CONTACT', 'email': 'clh@lppharma.com', 'phone': '+86 173-5003-2816'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiamen LP Pharmaceutical Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}