Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-25 @ 2:35 PM
Study NCT ID:
NCT03452150
Status:
COMPLETED
Last Update Posted:
2023-04-25
First Post:
2018-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
D-0316 First Time in Patients Ascending Dose Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-23', 'studyFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2018-02-28', 'lastUpdatePostDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicities (DLTs)', 'timeFrame': 'Day 1 - Day 28', 'description': 'Incidence of DLTs'}, {'measure': 'Adverse events', 'timeFrame': 'Day 1 - Day 28', 'description': 'Incidence of AEs'}, {'measure': 'Laboratory results', 'timeFrame': 'Day 1 - Day 28', 'description': 'Incidence of laboratory abnormalities'}, {'measure': 'Vital signs', 'timeFrame': 'Day 1 - Day 28', 'description': 'Incidence of vital sign abnormalities'}, {'measure': 'Electrocardiogram', 'timeFrame': 'Day 1 - Day 28', 'description': 'Incidence of ECG abnormalities'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic: area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'Day 1 through 6, Cycle Day 1-Day 15', 'description': 'AUC: area under the plasma concentration versus time curve for D-0316'}, {'measure': 'Pharmacokinetic: maximum plasma drug concentration (Cmax)', 'timeFrame': 'Day 1 through 6, Cycle Day 1-Day 15', 'description': 'Cmax: maximum plasma drug concentration of D-0316'}, {'measure': 'Pharmacokinetic: Time to reach the Cmax (Tmax)', 'timeFrame': 'Day 1 through 6, Cycle Day 1-Day 15', 'description': 'tmax: Time to reach the Cmax of D-0316'}, {'measure': 'Pharmacokinetic: Apparent terminal half-life (t1/2)', 'timeFrame': 'Day 1 through 6, Cycle Day 1-Day 15', 'description': 't1/2: apparent terminal half-life of D-0316'}, {'measure': 'Antitumor activity', 'timeFrame': 'From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months', 'description': 'Antitumor activity by evaluation of tumor response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Non Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '35274722', 'type': 'DERIVED', 'citation': 'Jian H, Wang K, Cheng Y, Ding L, Wang Y, Shi Z, Zhang L, Wang Y, Lu S. Phase I Trial of a Third Generation EGFR Mutant-Selective Inhibitor (D-0316) in Patients with Advanced Non-Small Cell Lung Cancer. Oncologist. 2022 Mar 11;27(3):163-e213. doi: 10.1093/oncolo/oyab007.'}]}, 'descriptionModule': {'briefSummary': 'This is a phase 1 open label multicentre study of D-0316 administered orally in patients with advanced NSCLC who have progressed following prior therapy with an EGFR-TKI (Epidermal Growth Factor Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever been tested in patients, and so it will help to understand safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses\n* Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC).\n* Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib. In addition other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.\n* Confirmation that the tumour harbours an EGFR T790M mutation.\n* No deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.\n* Evaluable or measurable disease per RECIST v1.1\n\nExclusion Criteria:\n\n* Treatment with an EGFR TKI (erlotinib or gefitinib) within 14 days of the first dose of study treatment.\n* Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.\n\nOther protocol defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT03452150', 'briefTitle': 'D-0316 First Time in Patients Ascending Dose Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'InventisBio Co., Ltd'}, 'officialTitle': 'A Phase I Study of D-0316 in Patients With Advanced Non Small Cell Lung Cancer With Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase', 'orgStudyIdInfo': {'id': 'XY-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Daily oral dose of D-0316', 'interventionNames': ['Drug: D-0316']}], 'interventions': [{'name': 'D-0316', 'type': 'DRUG', 'description': 'If initial dosing of D-0316 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose or maximum feasible dose is defined', 'armGroupLabels': ['Daily oral dose of D-0316']}]}, 'contactsLocationsModule': {'locations': [{'zip': '130012', 'city': 'Changchun', 'state': 'Jilin', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 43.88, 'lon': 125.32278}}, {'zip': '200030', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '310052', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InventisBio Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}