Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-01 @ 8:15 PM
Study NCT ID:
NCT04935359
Status:
COMPLETED
Last Update Posted:
2025-01-07
First Post:
2021-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-29', 'mcpReleaseN': 36, 'releaseDate': '2025-08-11'}, {'resetDate': '2025-09-10', 'mcpReleaseN': 37, 'releaseDate': '2025-09-10'}, {'resetDate': '2025-10-27', 'mcpReleaseN': 38, 'releaseDate': '2025-10-14'}], 'estimatedResultsFirstSubmitDate': '2025-08-11'}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723975', 'term': 'NIS-793'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}], 'ancestors': [{'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 511}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety run-in part: Percentage of participants with dose limiting toxicities (DLTs) during the first cycle (4 weeks) of treatment.', 'timeFrame': 'Up to 4 weeks', 'description': 'Percentage of participants with DLTs during the first cycle of treatment in the safety run-in part. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness or concomitant medication that occurs within the first cycle of treatment with NIS793 in combination with gemcitabine and nab-paclitaxel'}, {'measure': 'Randomized part: Overall survival (OS)', 'timeFrame': 'From randomization up to death, assessed up to approximately 19 months', 'description': 'OS is defined as the time from date of randomization to date of death due to any cause.'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants with Adverse Events (AEs)', 'timeFrame': 'Up to approximately 19 months', 'description': 'Percentage of participants with AEs including changes in laboratory parameters, vital signs, body weight and cardiac assessments'}, {'measure': 'Percentage of participants with dose interruptions and dose reductions of NIS793 in combination with gemcitabine and nab-paclitaxel', 'timeFrame': 'Up to approximately 19 months', 'description': 'Tolerability measured by the percentage of participants who have dose adjustments (interruptions or reductions) of NIS793'}, {'measure': 'Dose intensity of NIS793 in combination with gemcitabine and nab-paclitaxel', 'timeFrame': 'Up to approximately 19 months', 'description': 'Tolerability measured by the dose intensity of NIS793. Dose intensity will be computed as the ratio of actual cumulative dose received and actual duration of exposure'}, {'measure': 'Progression-free survival (PFS) by investigator assessment per RECIST 1.1', 'timeFrame': 'From enrollment (run-in part) or randomization (randomized part) up to disease progression or death, assessed up to approximately 19 months', 'description': 'PFS defined as the time from the date of enrollment (run-in part) or randomization (randomized part) to the date of the first documented progression based on investigator assessment and according to RECIST 1.1 or death due to any cause.'}, {'measure': 'Overall response rate (ORR) by investigator assessment per RECIST 1.1', 'timeFrame': 'Up to approximately 19 months', 'description': 'ORR is defined as the proportion of participants with best overall response (BOR) of complete response (CR) or partial response (PR), as per investigator assessment and according to RECIST 1.1'}, {'measure': 'Disease control rate (DCR) by investigator assessment per RECIST 1.1', 'timeFrame': 'Up to approximately 19 months', 'description': 'DCR is the proportion of participants with BOR of CR or PR or stable disease (SD) as per investigator assessment and according to RECIST 1.1'}, {'measure': 'Time to response (TTR) by investigator assessment per RECIST 1.1', 'timeFrame': 'From enrollment (run-in part) or randomization (randomized part) up to first documented response, assessed up to approximately 19 months', 'description': 'TTR is defined as the duration of time between the date of enrollment (run-in part) or randomization (randomized part) and the date of first documented response of either CR or PR.'}, {'measure': 'Safety run-in part: Overall Survival (OS)', 'timeFrame': 'From enrollment up to death, assessed up to approximately 19 months', 'description': 'OS is defined as the time from the date of enrollment to date of death due to any cause.'}, {'measure': 'Maximum concentration (Cmax) of NIS793 in combination with gemcitabine and nab-paclitaxel', 'timeFrame': 'From date of first study drug intake up to approximately 19 months', 'description': 'Blood samples will be collected for analysis of Cmax of NIS793'}, {'measure': 'Trough Concentration (Ctrough) of NIS793 in combination with gemcitabine and nab-paclitaxel', 'timeFrame': 'From date of first study drug intake up to approximately 19 months', 'description': 'Blood samples will be collected for analysis of Ctrough of NIS793'}, {'measure': 'Area under the curve from time zero to the last measurable concentration sampling time (AUClast) of NIS793 in combination with gemcitabine and nab-paclitaxel', 'timeFrame': 'From date of first study drug intake up to approximately 19 months', 'description': 'Blood samples will be collected for analysis of AUClast of NIS793'}, {'measure': 'Area under the curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) of NIS793 in combination with gemcitabine and nab-paclitaxel', 'timeFrame': 'From date of first study drug intake up to approximately 19 months', 'description': 'Blood samples will be collected for analysis of AUCtau of NIS793'}, {'measure': 'Time to reach maximum concentration (Tmax) of NIS793 in combination with gemcitabine and nab-paclitaxel', 'timeFrame': 'From date of first study drug intake up to approximately 19 months', 'description': 'Blood samples will be collected for analysis of Tmax of NIS793'}, {'measure': 'Randomized part: NIS793 serum concentration', 'timeFrame': 'From date of first study drug intake up to approximately 19 months', 'description': 'Blood samples will be collected for analysis of NIS793 serum concentration'}, {'measure': 'Randomized part: Anti-drug antibodies (ADA) against NIS793 prevalence at baseline', 'timeFrame': 'Baseline', 'description': 'ADA (anti-NIS793) prevalence at baseline is defined as the proportion of participants who have an ADA positive result at baseline'}, {'measure': 'Randomized part: ADA (anti-NIS793) incidence on treatment', 'timeFrame': 'From date of first study drug intake up to approximately 19 months', 'description': 'ADA (anti-NIS793) incidence on treatment is defined as the proportion of participants who are treatment-induced ADA positive (post-baseline ADA positive with ADA-negative sample at baseline) and treatment-boosted ADA positive (post-baseline ADA positive with titer that is at least the fold titer change greater than the ADA-positive baseline titer)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mPDAC', 'NIS793', 'Pancreas', 'metastatic pancreatic ductal adenocarcinoma (mPDAC)', 'Nab-paclitaxel', 'Abraxane', 'Gemcitabine'], 'conditions': ['Metastatic Pancreatic Ductal Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of NIS793 in combination with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel and placebo in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC).\n\nThis study aims to explore whether blockade of Transforming Growth Factor β (TGFβ) in combination with gemcitabine/nab-paclitaxel can reduce fibrosis in PDAC, restore chemo-sensitivity and ultimately lead to improvements in overall survival (OS) and other clinically relevant outcomes.', 'detailedDescription': 'This is a randomized, double-blind, multicenter two-arm, phase III study that has two parts:\n\n* Safety run-in part: An open-label safety run-in part will be conducted to confirm recommended phase 3 dose (RP3D) of NIS793 in combination with gemcitabine and nab-paclitaxel. Up to approximately 10 participants will be enrolled at each dose level to achieve at least 6 evaluable participants; however, if the starting dose is not recommended and a lower dose level is tested, 10 additional participants will be enrolled. The decision to open the randomized part will be based on dose confirmation and available safety, relevant PK, and other relevant data from run-in part\n* Randomized part: Enrolled participants will be randomized to the two treatment arms.\n\nThe study treatment will be administered as a 28-day treatment cycle. Participants will be treated until unacceptable toxicity, disease progression per RECIST 1.1, withdrawal of consent or any other condition of treatment discontinuation specified in the protocol.\n\nNote: As of 07-Jul-2023, treatment with NIS793/placebo was stopped. The trial was unblinded and study participants were allowed to continue with standard of care (SoC) chemotherapy (gemcitabine+ nab-paclitaxel) per investigator assessment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Applicable for both Safety run-in and Randomized part\n\n * Participants aged ≥18 years with histologically or cytologically confirmed (based on local assessment and per local guidelines) mPDAC eligible for treatment in the first line setting and not amenable for potentially curative surgery\n * Presence of at least one measurable lesion assessed by Computerized Tomography (CT) and/or Magnetic Resonance Imaging (MRI) according to RECIST 1.1\n * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1\n * Adequate organ function (assessed by central laboratory for eligibility)\n * Participants must have recovered from treatment-related toxicities of prior anticancer therapies to grade ≤ 1 (CTCAE v 5.0) at time of screening, except alopecia.\n\nMain Exclusion Criteria:\n\n* Applicable for both Safety run-in and Randomized part\n\n * Previous systemic anti-cancer treatment for metastatic PDAC\n * Pancreatic neuroendocrine (islet) or acinar tumors\n * Participants with known status of microsatellite instability-high (MSI-H) or mismatch repair-deficient pancreatic cancer (if status is not already available, testing is not required at screening).\n * Participant has not recovered from a major surgery performed prior to start of study treatment or has had a major surgery within 4 weeks prior to start of study treatment.\n * Radiation therapy or brain radiotherapy ≤ 4 weeks prior to start of study treatment (palliative radiotherapy to bone lesions allowed \\> 2 weeks prior to start of study treatment).\n * Impaired cardiac function or clinically significant cardio-vascular disease\n * Use of hematopoietic growth factors or transfusion support ≤ 2 weeks prior to start of study treatment.\n * Participant has conditions that are considered to have a high risk of clinically significant gastrointestinal tract bleeding or any other condition associated with or history of significant bleeding.\n * Serious non-healing wounds.\n * Pregnant or breast-feeding women\n * Women of childbearing potential, unless willing to use highly effective contraception methods during treatment and after stopping study treatments as indicated\n * Pre-existing peripheral neuropathy \\> grade 1 (CTCAE v5.0)'}, 'identificationModule': {'nctId': 'NCT04935359', 'briefTitle': 'Study of Efficacy and Safety of NIS793 in Combination With Standard of Care (SOC) Chemotherapy in First-line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double-blind, Phase III Study, Comparing NIS793 in Combination With Gemcitabine and Nab-paclitaxel Versus (vs.) Placebo Combined With Gemcitabine and Nab-paclitaxel for First Line Treatment of Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) - daNIS-2', 'orgStudyIdInfo': {'id': 'CNIS793B12301'}, 'secondaryIdInfos': [{'id': '2021-000591-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Safety run-in part: NIS793+gemcitabine+nab-paclitaxel', 'description': 'In the safety run-in part, participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel.', 'interventionNames': ['Drug: NIS793', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine']}, {'type': 'EXPERIMENTAL', 'label': 'Randomized part: NIS793+gemcitabine+nab-paclitaxel', 'description': 'Participants will receive a combination of NIS793, gemcitabine and nab-paclitaxel\n\nNote: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.', 'interventionNames': ['Drug: NIS793', 'Drug: Nab-paclitaxel', 'Drug: Gemcitabine', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Randomized part: placebo+gemcitabine+nab-paclitaxel', 'description': 'Participants will receive a combination of placebo, gemcitabine and nab-paclitaxel\n\nNote: As of 07-Jul-2023, treatment with NIS793/placebo was stopped.', 'interventionNames': ['Drug: Nab-paclitaxel', 'Drug: Gemcitabine', 'Drug: Placebo']}], 'interventions': [{'name': 'NIS793', 'type': 'DRUG', 'description': 'Concentrate for solution infusion (Liquid in Vial)', 'armGroupLabels': ['Randomized part: NIS793+gemcitabine+nab-paclitaxel', 'Safety run-in part: NIS793+gemcitabine+nab-paclitaxel']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'description': 'Per locally approved formulation', 'armGroupLabels': ['Randomized part: NIS793+gemcitabine+nab-paclitaxel', 'Randomized part: placebo+gemcitabine+nab-paclitaxel', 'Safety run-in part: NIS793+gemcitabine+nab-paclitaxel']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Per locally approved formulation', 'armGroupLabels': ['Randomized part: NIS793+gemcitabine+nab-paclitaxel', 'Randomized part: placebo+gemcitabine+nab-paclitaxel', 'Safety run-in part: NIS793+gemcitabine+nab-paclitaxel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Dextrose 5% in water (D5W) solution for infusion', 'armGroupLabels': ['Randomized part: NIS793+gemcitabine+nab-paclitaxel', 'Randomized part: placebo+gemcitabine+nab-paclitaxel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California LA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Health Cancer Institute', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '46815', 'city': 'Fort Wayne', 'state': 'Indiana', 'country': 'United States', 'facility': 'Fort Wayne Medical Oncology Hematology Inc', 'geoPoint': {'lat': 41.1306, 'lon': -85.12886}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Clinical Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '75204', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'US Oncology Research Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Huntsman Cancer Institute', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}, {'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '70200-730', 'city': 'Brasília', 'state': 'Federal District', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -15.77972, 'lon': -47.92972}}, {'zip': '98700-000', 'city': 'Ijuí', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -28.38778, 'lon': -53.91472}}, {'zip': '90035-001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '04014-002', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'L6R 3J7', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'N1R 3G2', 'city': 'Cambridge', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.3601, 'lon': -80.31269}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '150081', 'city': 'Harbin', 'state': 'Heilongjiang', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.75, 'lon': 126.65}}, {'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'zip': '116001', 'city': 'Dalian', 'state': 'Liaoning', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.91222, 'lon': 121.60222}}, {'zip': '272000', 'city': 'Jining', 'state': 'Shandong', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.405, 'lon': 116.58139}}, {'zip': '710061', 'city': 'Xian', 'state': 'Shanxi', 'country': 'China', 'facility': 'Novartis Investigative Site'}, {'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'zip': '310022', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '100021', 'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100036', 'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200127', 'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '200433', 'city': 'Shanghai', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '300480', 'city': 'Tianjin', 'country': 'China', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '656 53', 'city': 'Brno', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '74101', 'city': 'Nový Jičín', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.59438, 'lon': 18.01028}}, {'zip': '500 05', 'city': 'Hradec Králové', 'state': 'CZE', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '140 59', 'city': 'Prague', 'country': 'Czechia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '00290', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': 'FIN-33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '06189', 'city': 'Nice', 'state': 'Alpes Maritimes', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '84082', 'city': 'Avignon', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '69373', 'city': 'Lyon 08', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.73626, 'lon': 4.86866}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '44791', 'city': 'Bochum', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.48165, 'lon': 7.21648}}, {'zip': '45147', 'city': 'Essen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '60488', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'zip': '06120', 'city': 'Halle S', 'country': 'Germany', 'facility': 'Novartis Investigative Site'}, {'zip': '20249', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '89081', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '540 07', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '57001', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': 'H 1122', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': 'H-1097', 'city': 'Budapest', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '9112001', 'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '52621', 'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'zip': '6423906', 'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'zip': '50134', 'city': 'Florence', 'state': 'FI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20133', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20162', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '37126', 'city': 'Verona', 'state': 'VR', 'country': 'Italy', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '464 8681', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '277 8577', 'city': 'Kashiwa', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.86224, 'lon': 139.97732}}, {'zip': '241-8515', 'city': 'Yokohama', 'state': 'Kanagawa', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.43333, 'lon': 139.65}}, {'zip': '541-8567', 'city': 'Osaka', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}, {'zip': '104 0045', 'city': 'Chuo Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '135 8550', 'city': 'Koto Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Novartis Investigative Site'}, {'zip': '3543 AZ', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '1478', 'city': 'Nordbyhagen', 'state': 'Oslo County', 'country': 'Norway', 'facility': 'Novartis Investigative Site'}, {'zip': 'NO-0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '644013', 'city': 'Omsk', 'country': 'Russia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.99244, 'lon': 73.36859}}, {'zip': '196603', 'city': 'Pushkin Saint Petersburg', 'country': 'Russia', 'facility': 'Novartis Investigative Site'}, {'zip': '168583', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '83310', 'city': 'Bratislava', 'state': 'Slovak Republic', 'country': 'Slovakia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '975 17', 'city': 'Banská Bystrica', 'country': 'Slovakia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.73947, 'lon': 19.14932}}, {'zip': '041 91', 'city': 'Košice', 'country': 'Slovakia', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.71441, 'lon': 21.25802}}, {'zip': '06591', 'city': 'Seoul', 'state': 'Seocho Gu', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03080', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '08035', 'city': 'Barcelona', 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Catalonia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}, {'zip': '15706', 'city': 'Santiago de Compostela', 'state': 'Galicia', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '28009', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28034', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'SE-205 02', 'city': 'Malmo', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.60587, 'lon': 13.00073}}, {'zip': '901 85', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': '6500', 'city': 'Bellinzona', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}, {'zip': 'CH 1211', 'city': 'Geneva', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '10002', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11217', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '33305', 'city': 'Taoyuan District', 'country': 'Taiwan', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 24.9896, 'lon': 121.3187}}, {'zip': '01250', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '06230', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '34722', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': 'SM2 5PT', 'city': 'Sutton', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.35, 'lon': -0.2}}, {'zip': 'CB2 0QQ', 'city': 'Cambridge', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'CH63 4JY', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'EC1A 7BE', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'OX3 7LE', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.\n\nThis trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}