Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2026-02-26 @ 12:42 AM
Study NCT ID:
NCT02321293
Status:
UNKNOWN
Last Update Posted:
2015-09-02
First Post:
2014-12-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors (TKI) for EGFR -Mutant Advanced NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}, {'id': 'D000077156', 'term': 'Gefitinib'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-01', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2014-12-19', 'lastUpdatePostDateStruct': {'date': '2015-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'feasibility assessed by: Willingness of patients to participate= Number of enrolled/Number of approached patients,', 'timeFrame': '8 weeks', 'description': 'Feasibility will determine whether the use of curcumin is appropriate for further testing; and will be assessed by:\n\nWillingness of patients to participate= Number of enrolled/Number of approached patients,'}, {'measure': 'feasibility assessed by follow-up rate= number of actual study visits/ total number of study visits', 'timeFrame': '8 weeks', 'description': 'will by assessed by follow-up rate= number of actual study visits/ total number of study visits'}, {'measure': 'feasibility Adherence/Compliance rate= Number of taken capsules/Total number of capsules', 'timeFrame': '8 weeks', 'description': 'Adherence/Compliance rate= Number of taken capsules/Total number of capsules'}, {'measure': 'feasibility Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires', 'timeFrame': '8 weeks', 'description': 'Questionnaires completion rate= Number of completed questionnaires/Total number of questionnaires'}, {'measure': 'safety number of side effects', 'timeFrame': '16 weeks', 'description': 'Safety will be assessed by number of side effects'}], 'secondaryOutcomes': [{'measure': 'To evaluate and compare the changes in health-related quality of life before and after', 'timeFrame': '8 weeks', 'description': "Patients' quality of life on curcumin treatment will be assessed by the FACT-L at the baseline, 4 weeks,8 weeks on concurrent curcumin and TKI and 8 weeks post-study. Clinically important difference in the score is considered 2 points."}, {'measure': 'To evaluate anti-inflammatory properties of Curcumin (assessed by measuring C-reactive protein)', 'timeFrame': '8 weeks', 'description': 'anti-inflammatory effects of curcumin will be assessed by measuring C-reactive protein tests will be performed at baseline, 2, 4, 8 and 16 weeks into study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['curcumin', 'lung cancer', 'TKI'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is is to assess the safety and tolerability of curcumin in combination with EGFR-TKIs in selected patients with advanced non-resectable mutant EGFR NSCLC.', 'detailedDescription': 'This is a phase 1 open prospective cohort study to assess the safety and feasibility of using curcumin in conjunction with an EGFR-TKI in patients with advanced NSCLC. The investigators will use an enhanced bioavailable formulation of curcumin (CURCUViva TM at 80 mg/ 1 capsule per day) approved and licensed by Health Canada (NPN 80027414) that has been shown to have 2-3 times higher curcumin concentration in the blood as compared to previous clinical trials. As primary objective, the investigators will recruit 20 patients for a duration of 8 weeks to monitor adverse effects according to the the National Cancer Institute Common Terminology Criteria.Exploratory objectives would include assessing changes in health-related quality of life using the standardized FACT-L questionnaire and evaluating anti-inflammatory properties of curcumin by measuring CRP. If tolerable safety data is obtained, an expanded phase II trial will be designed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed or patients on treatment for histologically confirmed advanced EGFR-mutant NSCLC defined as unresectable stage 3A, stage 3B or stage 4.\n* The EGFR mutation analysis must be performed prior to enrolment into the trial (i.e., before a patient is consented). Any EGFR mutation-positive result must be documented and the analysis for the mutation will be performed using the JGH local testing methodology.\n* Receiving concurrent EGFR-TKI therapy.\n* Eastern Cooperative Oncology Group (ECOG) Performance Score 0-3\n\nExclusion Criteria:\n\n* Symptomatic brain metastases.\n* Patients who are receiving any other investigational agents.\n* Patients using other non-vitamin or mineral regular natural health product, which includes Chinese Herbs.\n* Incapacity to understand and sign a written informed consent document in English/French.\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02321293', 'acronym': 'CURCUMIN', 'briefTitle': 'A Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors (TKI) for EGFR -Mutant Advanced NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Lady Davis Institute'}, 'officialTitle': 'A Phase 1 Open-label Prospective Cohort Trial of Curcumin Plus Tyrosine Kinase Inhibitors for Epidermal Growth Factor Receptor (EGFR)-Mutant Advanced Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'JGH-14-149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'CurcuVIVA™ (NPN 80027414) at a single dose of 80 mg PO daily without any dose escalation to be taken in conjunction with an EGFR-TKI therapy.\n\nCurcuVIVA™ is given in capsule forms. Unit strength of CurcuVIVA™ is equal to Turmeric Extract 25:1 348 mg (containing 80mg Longvida® Optimized Curcumin)\n\nTyrosine Kinase Inhibitors:\n\n1. Gefitinib is a targeted therapy, given in a capsule form once daily. The daily dose is 250 mg .\n2. Erlotinib is a targeted therapy, given in a capsule form once daily. The daily dose is 150 mg .\n\nStudy intervention is 8 weeks, following which the patients will continue taking their EGFR-TKI without curcumin until progression. The side effects of curcumin will be followed for another 8 weeks from the date of stopping curcumin.', 'interventionNames': ['Dietary Supplement: CurcuVIVA™', 'Drug: Tyrosine Kinase Inhibitor gefitinib (Iressa)', 'Drug: Tyrosine Kinase Inhibitor erlotinib (Tarceva)']}], 'interventions': [{'name': 'CurcuVIVA™', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Curcumin'], 'description': '80 mg PO daily for 8 weeks with an option to reduce the dose based on individual tolerability', 'armGroupLabels': ['1']}, {'name': 'Tyrosine Kinase Inhibitor gefitinib (Iressa)', 'type': 'DRUG', 'otherNames': ['gefitinib (Iressa)'], 'description': '250 mg PO daily until progression', 'armGroupLabels': ['1']}, {'name': 'Tyrosine Kinase Inhibitor erlotinib (Tarceva)', 'type': 'DRUG', 'otherNames': ['erlotinib (Tarceva)'], 'description': '150 mg PO daily until progression', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Victor Cohen, MD,CM, FRCPC', 'role': 'CONTACT', 'email': 'vcohen@jgh.mcgill.ca', 'phone': '514-340-8222', 'phoneExt': '3878'}, {'name': 'Goulnar Kasymjanova, MD', 'role': 'CONTACT', 'email': 'gkasymja@jgh.mcgill.ca', 'phone': '514-340-8222', 'phoneExt': '4312'}, {'name': 'Khashayar Esfahani, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Arif Awan, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thomas R Jagoe, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jason S Agulnik, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'David Small, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carmela Pepe, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Lama Sakr, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Goulnar Kasymjanova, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Peter Brojge Lung Cancer Center, Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Victor Cohen, MD', 'role': 'CONTACT', 'email': 'vcohen@jgh.mcgill.ca', 'phone': '514-340-8222', 'phoneExt': '3877'}, {'name': 'Goulnar Kasymjanova, MD', 'role': 'CONTACT', 'email': 'gkasymja@jgh.mcgill.ca', 'phone': '514-340-8222', 'phoneExt': '4312'}], 'overallOfficials': [{'name': 'Victor Cohen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lady Davis Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lady Davis Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jewish General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,CM, FRCPC', 'investigatorFullName': 'Dr. Victor Cohen', 'investigatorAffiliation': 'Lady Davis Institute'}}}}