Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2026-01-03 @ 10:19 PM
Study NCT ID:
NCT02399592
Status:
COMPLETED
Last Update Posted:
2020-11-30
First Post:
2015-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-26', 'studyFirstSubmitDate': '2015-03-20', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fraction of patients without progression after six months of treatment', 'timeFrame': '6 months after start of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Platinum resistant'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to to investigate the effect of tocotrienol as a nutritional supplement in combination with bevacizumab in patients with advanced ovarian cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.\n* Prior treatment with at least two different cytostatic regimens including platinum.\n* Progression on previous treatment.\n* Measurable disease by RECIST 1.1 or evaluable by GCIG CA-125 criteria.\n* Age ≥ 18 years.\n* Performance stage 0-2.\n* Adequate bone marrow function, liver function, and renal function (within 7 days prior to inclusion):\n\n * WBC ≥ 3.0 \\* 10\\^9/l or neutrophils (ANC) ≥ 1.5 \\* 109/l\n * Platelet count ≥ 100 \\* 10\\^9/l\n * Hemoglobin ≥ 6 mmol/l\n * Serum bilirubin \\< 2.0 \\* ULN\n * Serum transaminase ≤ 2.5 \\* ULN\n * Serum creatinine ≤ 1.5 ULN\n* Urine dipstick for protein \\<2+. If the dipstick shows protein ≥2+ 24 hour urine testing must be made with protein contents \\< 1 g.\n* Written informed consent.\n\nExclusion Criteria:\n\n* Other malignant diseases within 5 years prior to inclusion in the study, except curatively treated basal cell or squamous cell carcinoma of the skin and other types of cancer with minimal risk of recurrence.\n* Other experimental therapy or participation in another clinical trial within 28 days prior to treatment initiation.\n* Underlying medical disease not adequately treated (diabetes, cardiac disease).\n* Uncontrolled hypertension (BT \\>150/100 despite antihypertensive treatment).\n* Surgery, incl. open biopsy, within 4 weeks prior to first dose of bevacizumab.\n* Non-healing wounds or fractures.\n* Cerebral vascular attack, transient ischemic attack or subarachnoidal hemorhage within 6 months before start of treatment.\n* Clinically significant cardiovascular disease, including:\n\n * Myocardial infarction or unstable angina within 6 months before start of treatment\n * New York heart Association (NYHA) class ≥ 2\n * Poorly controlled cardiac arrhythmia despite medication\n * Periferal vascular disease grade ≥ 3\n* Allergy to the active substance or any of the auxiliary agents\n* Bleeding tumor\n* Pregnant or breast-feeding patients. For fertile women a negative pregnancy test at screening is mandatory.\n* Fertile patients not willing to use effective methods of contraception during treatment and for 6 months after the end of treatment'}, 'identificationModule': {'nctId': 'NCT02399592', 'acronym': 'Toco-Ovar', 'briefTitle': 'Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vejle Hospital'}, 'officialTitle': 'Tocotrienol as a Nutritional Supplement in Patients With Advanced Ovarian Cancer', 'orgStudyIdInfo': {'id': 'Toco-Ovar'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bevacizumab and Tocotrienol', 'interventionNames': ['Drug: Bevacizumab', 'Drug: Tocotrinol']}], 'interventions': [{'name': 'Bevacizumab', 'type': 'DRUG', 'description': '10 mg/kg q3w', 'armGroupLabels': ['Bevacizumab and Tocotrienol']}, {'name': 'Tocotrinol', 'type': 'DRUG', 'description': '300 mg tid', 'armGroupLabels': ['Bevacizumab and Tocotrienol']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-7100', 'city': 'Vejle', 'country': 'Denmark', 'facility': 'Department of Oncology, Vejle Hospital', 'geoPoint': {'lat': 55.70927, 'lon': 9.5357}}], 'overallOfficials': [{'name': 'Anders Jakobsen, DMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Oncology, Vejle Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vejle Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}