Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-01-01 @ 8:04 PM
Study NCT ID:
NCT03960151
Status:
WITHDRAWN
Last Update Posted:
2019-05-22
First Post:
2018-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C578834', 'term': 'rolapitant'}, {'id': 'D000077924', 'term': 'Palonosetron'}, {'id': 'D000077152', 'term': 'Olanzapine'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D013256', 'term': 'Steroids'}], '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'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Compound was sold by funder and development ceased.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-21', 'studyFirstSubmitDate': '2018-03-26', 'studyFirstSubmitQcDate': '2019-05-21', 'lastUpdatePostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete Response Rate', 'timeFrame': '8 Days', 'description': 'Determine the complete response (CR) rate defined as no emesis and no use of rescue medications in germ cell tumor patients treated with rolapitant plus Olanzapine in combination with palonosetron a 5HT3RA and dexamethasone on Cycle 1 Day 1 through Day 8'}], 'secondaryOutcomes': [{'measure': 'Complete Response Rate: Acute Phase', 'timeFrame': '5 Days', 'description': 'Determine the CR rate in the acute phase (Days 1-5) defined as no emesis and no use of rescue medications in germ cell tumor patients treated with rolapitant plus Olanzapine in combination with palonosetron a 5HT3RA and dexamethasone on Cycle 1 Day 1 through Day 5'}, {'measure': 'Complete Response Rate: Delayed Phase', 'timeFrame': '2 Days', 'description': 'Determine the CR rate in the delayed phase (Days 6-8) defined as no emesis and no use of rescue medications in germ cell tumor patients treated with rolapitant plus Olanzapine in combination with palonosetron a 5HT3RA and dexamethasone on Cycle 1 Day 6 through Day 8'}, {'measure': 'Frequency, intensity, and duration of nausea', 'timeFrame': '8 Days', 'description': 'Determine the frequency, intensity and duration of nausea on Days 1-8 in Cycle 1. The frequency, intensity and duration of nausea will be captured via daily self-assessment patient logs.'}, {'measure': 'Frequency of vomiting or retching.', 'timeFrame': '8 Days', 'description': 'Determine the frequency, intensity and duration of vomiting or retching on Days 1-8 in Cycle 1. The frequency of vomiting and retching will be captured via daily self-assessment patient logs.'}, {'measure': 'Intensity of Vomiting or retching.', 'timeFrame': '8 Days', 'description': 'Determine the intensity of vomiting or retching on Days 1-8 in Cycle 1. The intensity of vomiting and retching will be captured via daily self-assessment patient logs.'}, {'measure': 'Duration of Vomiting or retching', 'timeFrame': '8 Days', 'description': 'Determine the duration of vomiting or retching on Days 1-8 in Cycle 1. The duration of vomiting and retching will be captured via daily self-assessment patient logs.'}, {'measure': 'Rate of no nausea', 'timeFrame': '8 Days', 'description': 'Determine the rate of no nausea defined as \\< 5mm on a 0-100mm visual analog scale (VAS) on Days 1-5 and Days 6-8 on Cycle 1'}, {'measure': 'Use of rescue medications', 'timeFrame': '8 Days', 'description': 'Describe the use of rescue medications as defined in the protocol'}, {'measure': 'Assess adverse events of regimen using CTCAE v4.', 'timeFrame': '8 Days', 'description': 'Safety and toxicity will be assessed using CTCAE v4'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Germ Cell Tumor']}, 'descriptionModule': {'briefSummary': 'Phase II study of Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone in patients with germ cell tumors undergoing 5-day Cisplatin-based chemotherapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.\n* Age ≥ 15 years at the time of consent.\n* Must be able to take oral medications (swallow pills)\n* ECOG Performance Status of 0-2 within 14 days prior to registration.\n* Histological or serological confirmation of germ cell tumor planning on receiving a standard 5 day cisplatin based chemotherapy regimen.\n* Patients must have had no nausea or vomiting for 24 hours and no antiemetic use for 72 hours prior to starting protocol therapy.\n* No active central nervous system (CNS) metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. A subject with prior brain metastasis may be considered if they have completed their treatment for brain metastasis at least 4 weeks prior to study registration, have been off of corticosteroids for ≥ 2 weeks, and are asymptomatic.\n* Prior cancer treatments are not allowed. Patients have to be chemotherapy naïve.\n* Absolute Neutrophil Count (ANC) ≥ 1 K/mm3\n* Hemoglobin (Hgb) ≥ 10 g/dL\n* Platelets (Plt) ≥ 100 K/mm3\n* Creatinine ≤ 2 mg/dL\n* Bilirubin ≤ 1.5 × upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) ≤ 2.5 × ULN\n* Alanine aminotransferase (ALT) ≤ 2.5 × ULN\n* No concurrent use of thioridazine or pimozide. No use of agents expected to induce the metabolism of rolapitant which include: Rifampin, Rifabutin, Phenytoin, Carbamazepine, and Barbiturates.\n* As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study\n* Patients and their partners must agree to use a highly effective method of birth control from the signing of the informed consent form until 90 days following the last dose of rolapitant.\n\nExclusion Criteria:\n\n* Any untreated central nervous system (CNS) metastases.\n* Treatment with any investigational drug within 30 days prior to registration.\n* Concurrent participation in a clinical trial which involves another investigational agent.'}, 'identificationModule': {'nctId': 'NCT03960151', 'briefTitle': 'Rolapitant Plus Olanzapine in Multiday Cisplatin Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Hoosier Cancer Research Network'}, 'officialTitle': 'Phase II Study of Rolapitant Plus Olanzapine, Palonosetron, and Dexamethasone in Patients With Germ Cell Tumors Undergoing 5-day Cisplatin-based Chemotherapy.', 'orgStudyIdInfo': {'id': 'HCRN GU16-254'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rolapitant', 'description': 'Rolapitant plus Olanzapine, Palonosetron, and Dexamethasone', 'interventionNames': ['Drug: Rolapitant', 'Drug: Palonosetron', 'Drug: Olanzapine', 'Drug: Dexamethasone']}], 'interventions': [{'name': 'Rolapitant', 'type': 'DRUG', 'otherNames': ['Varubi'], 'description': 'Rolapitant 180mg PO, Days 1 and 5', 'armGroupLabels': ['Rolapitant']}, {'name': 'Palonosetron', 'type': 'DRUG', 'otherNames': ['Aloxi'], 'description': 'Palonosetron 0.25 mg IV, Days 1,3, and 5.', 'armGroupLabels': ['Rolapitant']}, {'name': 'Olanzapine', 'type': 'DRUG', 'otherNames': ['Zyprexa'], 'description': 'Olanzapine 10 mg PO PM, Days 2,3,4,5,6-8', 'armGroupLabels': ['Rolapitant']}, {'name': 'Dexamethasone', 'type': 'DRUG', 'otherNames': ['steroid'], 'description': 'Dexamethasone 20 mg AM, Days 1,2 and 3', 'armGroupLabels': ['Rolapitant']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Costantine Albany, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University Melvin and Bren Simon Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Costantine Albany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Tesaro, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sponsor Investigator', 'investigatorFullName': 'Costantine Albany', 'investigatorAffiliation': 'Hoosier Cancer Research Network'}}}}