Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:13 PM
Study NCT ID:
NCT03596658
Status:
TERMINATED
Last Update Posted:
2022-09-01
First Post:
2018-06-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer
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': 4}}, 'statusModule': {'whyStopped': 'Sponsor R \\& D Strategy Adjustment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-29', 'studyFirstSubmitDate': '2018-06-25', 'studyFirstSubmitQcDate': '2018-07-12', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limited Toxicity (DLT)', 'timeFrame': 'baseline through 28 days', 'description': 'to determine DLT in order to assess the tolerability of SHR9549'}, {'measure': 'Maximum Tolerated Dose (MTD)', 'timeFrame': 'baseline through 28 days', 'description': 'to determine MTD in order to assess the tolerability of SHR9549'}], 'secondaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'baseline through 12 weeks', 'description': 'Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals'}, {'measure': 'Area under the plasma concentration versus time curve (AUC)', 'timeFrame': 'baseline through 12 weeks', 'description': 'Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals'}, {'measure': 'overall response rate (ORR)', 'timeFrame': 'every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months', 'description': 'Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)'}, {'measure': 'progression free survival (PFS)', 'timeFrame': 'every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months', 'description': "Antitumour activity evaluation by following up patients' progression and survival"}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'baseline through 30 days after study completion', 'description': 'to assess the safety of SHR9549'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ER+ HER2- Advanced Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase 1 open label multicentre study of SHR9549 administered orally in patients with advanced estrogen receptor (ER) positive human epidermal receptor 2 (HER2) negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose(MTD). In addition, expansion cohort(s) at potential therapeutic dose(s) in patients will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of SHR9549.', 'detailedDescription': 'A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women with Estrogen Receptor (ER) Positive Human Epidermal Receptor (HER-2) Negative Advanced Breast Cancer'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-70 years.\n* Confirmation of ER positive; HER2 negative Advanced breast cancer\n* Documented disease progression after at least 6 months prior endocrine therapy for ER positive breast cancer.\n* Receipt of ≤2 lines of prior chemotherapy for advanced disease.\n* Any menopausal status.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and with minimum life expectancy of 12 weeks.\n\nExclusion Criteria:\n\n* Any anti-cancer drugs for the treatment of advanced breast cancer within 14 days of the first dose of study treatment.\n* Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia.\n* Patient who is unsuitable for endocrine therapy alone including presence of life-threatening metastatic visceral disease.\n* uncontrolled central nervous system metastatic disease.\n* Any evidence of severe or uncontrolled systemic diseases.\n* Inadequate bone marrow reserve or organ function.'}, 'identificationModule': {'nctId': 'NCT03596658', 'briefTitle': 'SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women With ER Positive HER2 Negative Advanced Breast Cancer', 'orgStudyIdInfo': {'id': 'SHR9549-I-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR9549 dose escalation and expansion(s)', 'description': 'Escalating dose of SHR9549 with intensive safety monitoring to ensure the safety of patients', 'interventionNames': ['Drug: SHR9549']}], 'interventions': [{'name': 'SHR9549', 'type': 'DRUG', 'otherNames': ['SHR9549 tablet'], 'description': 'If initial dosing of SHR9549 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose(MTD) is defined', 'armGroupLabels': ['SHR9549 dose escalation and expansion(s)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100071', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "The 307th Hospital of Military Chinese People's Liberation Army", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}