Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT02684032
Status:
COMPLETED
Last Update Posted:
2022-07-27
First Post:
2016-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D009477', 'term': 'Hereditary Sensory and Autonomic Neuropathies'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D011115', 'term': 'Polyneuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549060', 'term': 'gedatolisib'}, {'id': 'C500026', 'term': 'palbociclib'}, {'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D000077267', 'term': 'Fulvestrant'}], 'ancestors': [{'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 141}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-25', 'studyFirstSubmitDate': '2016-02-10', 'studyFirstSubmitQcDate': '2016-02-11', 'lastUpdatePostDateStruct': {'date': '2022-07-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with dose limiting toxicities', 'timeFrame': 'up to 28 days'}, {'measure': 'Objective response rate observed in patients in the dose expansion portion', 'timeFrame': '16 weeks', 'description': 'Number of patients for each response category, objective response rate (number of patients with a complete response (CR)) relative to the number of response evaluable patients'}, {'measure': 'Objective response rate observed in patients in the dose expansion portion', 'timeFrame': '16 weeks', 'description': 'Number of patients for each response category, objective response rate (number of patients with a partial response (PR)) relative to the number of response evaluable patients)'}], 'secondaryOutcomes': [{'measure': 'Tumor response observed in patients in the dose escalation portion', 'timeFrame': '16 weeks'}, {'measure': 'Duration of response', 'timeFrame': '16 weeks'}, {'measure': 'QTc interval (corrected QT interval)', 'timeFrame': 'Screening up to 6 months', 'description': "The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle."}, {'measure': 'Maximum observed plasma concentration', 'timeFrame': 'Day 1: 0, 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 24, 72 and 168 hours. Cycle 2 Day 1: 0, 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 24, 72 and 168 hours'}, {'measure': 'Progression free survival', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PI3K (phosphoinositide 3-kinase)', 'mTOR (mechanistic target of rapamycin)', 'PI3K/mTOR', 'metastatic breast cancer (MBC)', 'ER+ (estrogen receptor positive)', 'HER2- (human epidermal growth factor receptor 2 negative)'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '38547892', 'type': 'DERIVED', 'citation': 'Layman RM, Han HS, Rugo HS, Stringer-Reasor EM, Specht JM, Dees EC, Kabos P, Suzuki S, Mutka SC, Sullivan BF, Gorbatchevsky I, Wesolowski R. Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study. Lancet Oncol. 2024 Apr;25(4):474-487. doi: 10.1016/S1470-2045(24)00034-2.'}], 'seeAlsoLinks': [{'url': 'https://pmiform.com/clinical-trial-info-request?StudyID=B2151009', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole and expansion to estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole or palbociclib/fulvestrant.', 'detailedDescription': 'This is a multicenter, open label, continuous Phase 1b study in patients with MBC. This study will have a dose escalation and expansion. The dose escalation will identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and gedatolisib plus palbociclib/letrozole. The expansion will estimate the objective response rate (OR) of the combination of gedatolisib plus palbociclib/letrozole and the combination of gedatolisib plus palbociclib/fulvestrant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women 18 years of age or older, who are either: Postmenopausal or Pre/perimenopausal women with medically-induced menopause by treatment with agents to induce chemical menopause.\n* Histologically or cytologically proven diagnosis of breast cancer with evidence of metastasis.\n* Documentation of estrogen receptor positive ((ER+), human epidermal growth factor receptor 2 (HER2 negative (HER2-)) tumor.\n* Dose Escalation Portion: Patients must satisfy one of the following criteria:\n\n * Letrozole combination cohort (L): metastatic breast cancer (MBC) with progression who are candidates for a letrozole-containing regimen, with palbociclib.\n * Fulvestrant combination cohort (F): MBC with progression who are candidates for a fulvestrant containing regimen, with palbociclib.\n* Dose Expansion Portion: Patients must satisfy one of the following criteria:\n\n * Arm A: MBC with progression and no prior endocrine based systemic therapy in the metastatic setting;\n * Arm B: MBC with progression during or following one prior endocrine based systemic therapy in the metastatic setting, with no prior therapy with any cyclin-dependent kinase (CDK) inhibitor;\n * Arm C/Arm D: MBC with progression during or following one or two prior endocrine based systemic therapies in the metastatic setting, and following prior therapy with a CDK inhibitor.\n* Measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.\n* Bone only patients during dose escalation portion.\n* Availability of archival tumor biopsy sample or willing to provide fresh biopsy if not available.\n* Eastern Cooperative Oncology Group \\[ECOG\\] performance must be 0 or 1.\n* Adequate bone marrow, renal and liver function.\n\nExclusion Criteria:\n\n* Prior treatment with a mechanistic target of rapamycin (mTOR) inhibitor or phosphoinositide 3-kinase (PI3K) inhibitor.\n* More than 1 line of prior chemotherapy in the treatment of metastatic or locally advanced/recurrent disease.\n* Bone only patients during expansion/efficacy portion.\n* Patients with advanced/metastatic disease who have symptomatic visceral spread, and who have life threatening complications needing immediate therapy, such as massive uncontrolled effusions \\[pleural, pericardial, peritoneal\\], pulmonary lymphangitis, and over 50% liver replacement with tumor.\n* Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases.\n* Active bacterial, fungal or viral infection.\n* Uncontrolled or significant cardiovascular disease.\n* Radiation therapy within 4 weeks of investigational product.\n* Cytotoxic chemotherapy within 4 weeks of investigational product (6 weeks for mitomycin C or nitrosoureas) if immediate prior regimen was administered on an every 3 4 week schedule or 2 weeks of investigational product if immediate prior regimen consisted of weekly therapy.\n* Any other anti cancer agents (eg, hormonal, biological, investigational) within 5 times the half life prior to investigational product.\n* Impairment of gastro intestinal (GI) function or GI disease.\n* Pregnant female patients; breastfeeding female patients; and female patients of childbearing potential who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol for the duration of the study and for 90 days.'}, 'identificationModule': {'nctId': 'NCT02684032', 'briefTitle': 'A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celcuity Inc'}, 'officialTitle': 'PHASE 1B STUDY TO ASSESS THE SAFETY, TOLERABILITY, AND CLINICAL ACTIVITY OF GEDATOLISIB IN COMBINATION WITH PALBOCICLIB AND EITHER LETROZOLE OR FULVESTRANT IN WOMEN WITH METASTATIC OR LOCALLY ADVANCED/RECURRENT BREAST CANCER (MBC)', 'orgStudyIdInfo': {'id': 'B2151009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Letrozole Cohort', 'description': 'Letrozole combination cohort in dose escalation', 'interventionNames': ['Drug: Gedatolisib', 'Drug: Palbociclib', 'Drug: Letrozole']}, {'type': 'EXPERIMENTAL', 'label': 'Fulvestrant cohort', 'description': 'Fulvestrant combination cohort in dose escalation', 'interventionNames': ['Drug: Gedatolisib', 'Drug: Palbociclib', 'Drug: Fulvestrant']}, {'type': 'EXPERIMENTAL', 'label': 'ARM A', 'description': 'Gedatolisib + palbociclib + letrozole in dose expansion', 'interventionNames': ['Drug: Gedatolisib', 'Drug: Palbociclib', 'Drug: Letrozole']}, {'type': 'EXPERIMENTAL', 'label': 'ARM B', 'description': 'Gedatolisib + palbociclib + fulvestrant in dose expansion', 'interventionNames': ['Drug: Gedatolisib', 'Drug: Palbociclib', 'Drug: Fulvestrant']}, {'type': 'EXPERIMENTAL', 'label': 'ARM C', 'description': 'Gedatolisib + palbociclib + fulvestrant in dose expansion', 'interventionNames': ['Drug: Gedatolisib', 'Drug: Palbociclib', 'Drug: Fulvestrant']}, {'type': 'EXPERIMENTAL', 'label': 'Arm D', 'description': 'Gedatolisib (3:1) + palbociclib + fulvestrant in dose expansion', 'interventionNames': ['Drug: Fulvestrant']}], 'interventions': [{'name': 'Gedatolisib', 'type': 'DRUG', 'description': 'Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.', 'armGroupLabels': ['ARM A', 'ARM B', 'ARM C', 'Fulvestrant cohort', 'Letrozole Cohort']}, {'name': 'Palbociclib', 'type': 'DRUG', 'description': 'Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.', 'armGroupLabels': ['ARM A', 'ARM B', 'ARM C', 'Fulvestrant cohort', 'Letrozole Cohort']}, {'name': 'Letrozole', 'type': 'DRUG', 'description': 'Letrozole at 2.5 mg daily', 'armGroupLabels': ['ARM A', 'Letrozole Cohort']}, {'name': 'Fulvestrant', 'type': 'DRUG', 'description': 'Fulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.', 'armGroupLabels': ['ARM B', 'ARM C', 'Arm D', 'Fulvestrant cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92879', 'city': 'Corona', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.', 'geoPoint': {'lat': 33.87529, 'lon': -117.56644}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Hospital of USC - Norris Healthcare Center (HC3)', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck Hospital of USC', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'LAC+USC Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center / Investigational Drug Services', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92501', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Care Research Group Inc. at Compassionate Cancer Care Medical Group, Inc.', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF - Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF - Helen Diller Family Comprehensive Cancer Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital - Anschutz Inpatient Pavilion (AiP)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital - Clinical Trials Office (CTO)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Hospital- Anschutz Cancer Pavilion (ACP)', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center Richard M Schulze Family Foundation Outpatient Center at McKinley Campus', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital Midtown', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48334', 'city': 'Farmington Hills', 'state': 'Michigan', 'country': 'United States', 'facility': 'Karmanos Cancer Institute', 'geoPoint': {'lat': 42.48531, 'lon': -83.37716}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Cancer Hospital Infusion Pharmacy', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27514', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'UNC Hospitals, The University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Wexner Medical Center James Cancer Hospital', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Stefanie Spielman Comprehensive Breast Cancer', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University - Clinical and Regulatory', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37204', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Breast Center at One Hundred Oaks', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Henry-Joyce Cancer Clinic', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'U.T. MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22031', 'city': 'Fairfax', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cancer Specialists, PC', 'geoPoint': {'lat': 38.84622, 'lon': -77.30637}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance (SCCA) Investigational Drug Services', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Igor Gorbatchevsky, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Celcuity Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Celcuity will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celcuity Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}