Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-07 @ 4:53 AM
Study NCT ID:
NCT05325866
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2022-04-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D000077192', 'term': 'Adenocarcinoma of Lung'}, {'id': 'D000077216', 'term': 'Carcinoma, Ovarian Epithelial'}, {'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000714767', 'term': 'bemarituzumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 260}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-02-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-04-06', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)', 'timeFrame': 'Day 1 to Day 28'}, {'measure': 'Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)', 'timeFrame': 'Day 1 to 28 days after last dose (a maximum of 2 years)', 'description': 'Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.'}, {'measure': 'Part 1: Number of Participants Who Experience a Treatment-related Adverse Event', 'timeFrame': 'Day 1 to 28 days after last dose (a maximum of 2 years)'}, {'measure': 'Part 2: Objective Response (OR) Rate', 'timeFrame': 'Up to approximately 2 years', 'description': 'OR = complete response (CR) + partial response (PR), measured by computed tomography (CT) or magnetic resonance imaging (MRI) as determined by investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).'}], 'secondaryOutcomes': [{'measure': 'Part 1: OR Rate', 'timeFrame': 'Up to approximately 2 years', 'description': 'OR = CR + PR, measured by CT or MRI as determined by investigator per RECIST v1.1.'}, {'measure': 'Parts 1 and 2: Disease Control (DC) Rate', 'timeFrame': 'Up to approximately 2 years', 'description': 'DC = CR, PR, or stable disease (SD).'}, {'measure': 'Parts 1 and 2: Duration of Response (DOR)', 'timeFrame': 'Up to approximately 2 years', 'description': 'DOR, defined as the time from first documentation of OR (as determined by investigator per RECIST v1.1) until the first documentation of disease progression or death due to any cause, whichever occurs first. Only participants who have achieved OR will be evaluated for DOR. DOR will be censored at the last evaluable post-baseline tumor assessment prior to subsequent anticancer therapy.'}, {'measure': 'Parts 1 and 2: Time to Response', 'timeFrame': 'Up to approximately 2 years'}, {'measure': 'Parts 1 and 2: Progression-free Survival (PFS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'PFS, defined as time from first dose of investigational product until the first documentation of radiologic disease progression or death due to any cause. PFS will be censored at the last evaluable post-baseline tumor assessment prior to subsequent therapy. Progression will be based on RECIST v1.1 (derived utilizing investigator tumor assessments).'}, {'measure': 'Parts 1 and 2: Overall Survival (OS)', 'timeFrame': 'Up to approximately 2 years', 'description': 'OS, defined as time from first dose of investigational product until death from any cause. Participants still alive will be censored at the date last known to be alive.'}, {'measure': 'Part 2: Number of Participants Who Experience a TEAE', 'timeFrame': 'Day 1 to 28 days after last dose (a maximum of 2 years)', 'description': 'AEs are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, visual acuity, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.'}, {'measure': 'Part 2: Number of Participants Who Experience a Treatment-related AE', 'timeFrame': 'Day 1 to 28 days after last dose (a maximum of 2 years)'}, {'measure': 'Parts 1 and 2: Area Under the Concentration Time Curve (AUC) of Bemarituzumab', 'timeFrame': 'Day 1 to 28 days after last dose (a maximum of 2 years)'}, {'measure': 'Parts 1 and 2: Maximum Observed Serum Concentration (Cmax) of Bemarituzumab', 'timeFrame': 'Day 1 to 28 days after last dose (a maximum of 2 years)'}, {'measure': 'Parts 1 and 2: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab', 'timeFrame': 'Day 1 to 28 days after last dose (a maximum of 2 years)'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epithelial solid tumors with fibroblast growth factor receptor 2b overexpression', 'FGFR2b', 'Head and neck squamous cell carcinoma', 'Triple-negative breast cancer', 'Intrahepatic cholangiocarcinoma', 'Lung adenocarcinoma', 'Ovarian epithelial carcinoma', 'Endometrial adenocarcinoma', 'Cervical carcinoma', 'Bemarituzumab', 'AMG 552', 'Other solid tumors'], 'conditions': ['Solid Tumors']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.amgentrials.com', 'label': 'AmgenTrials clinical trials website'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years (or legal adult age within country, whichever is older) at the time that the Informed Consent Form (ICF) is signed\n2. Histologically or cytologically confirmed cancer of one of the following types, refractory to or relapsed after at least 1 prior standard therapeutic regimen in the advanced/metastatic setting, as specified below. If no standard of care therapies exist for the participant, or the participant cannot tolerate or refuses standard of care anticancer therapy, the participant may be allowed to participate on the study after discussion between the investigator and Amgen medical monitor. Participants who have not received all approved or standard treatments for their cancer must be informed that these alternatives to receiving bemarituzumab are available prior to consenting to participate in the trial.\n\n * head and neck squamous cell carcinoma: ≥ 1 line of therapy\n * triple-negative breast cancer: ≥ 2 lines of therapy\n * Intrahepatic cholangiocarcinoma ≥ 1 line of therapy\n * lung adenocarcinoma: at least platinum-based chemotherapy, checkpoint inhibitor, and targeted therapy\n * platinum resistant ovarian epithelial cell carcinoma, including fallopian tube cancers and primary peritoneal cancers, defined as progression during or within 6 months of a platinum containing regimen: ≥ 1 line of therapy\n * endometrial adenocarcinoma: ≥ 1 line of therapy\n * cervical carcinoma: ≥ 1 line of therapy\n * other solid tumors: ≥ 1 line of therapy\n3. Disease that is unresectable, locally advanced, or metastatic (not amenable to curative therapy)\n4. Tumor overexpresses FGFR2b as determined by centrally performed immunohistochemistry (IHC) testing\n5. Measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n7. Adequate organ function as determined per protocol.\n\nExclusion Criteria:\n\n1. Untreated or symptomatic central nervous system (CNS) metastases or leptomeningeal disease.\n2. Other solid tumor cohort excludes primary tumors of the CNS, squamous non-small cell lung cancer, gastric adenocarcinoma, and gastroesophageal junction adenocarcinoma\n3. Impaired cardiac function or clinically significant cardiac disease including: unstable angina within 6 months prior to first dose of study treatment, acute myocardial infarction ≥ 6 months prior to first dose of study treatment, New York Heart Association (NYHA) class II-IV congestive heart failure, uncontrolled hypertension (defined as an average systolic blood pressure ≥ 160 mmHg or diastolic ≥ 100 mmHg despite optimal treatment, uncontrolled cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin, active coronary artery disease or corrected QT interval QTc ≥ 470\n4. History of systemic disease or ophthalmologic disorders requiring chronic use of ophthalmic steroids\n5. Evidence of any ongoing ophthalmologic abnormalities or symptoms that are acute (within 4 weeks) or actively progressing\n6. Unwillingness to avoid use of contact lenses during study treatment and for at least 100 days after the end of treatment\n7. Recent (within 6 months) corneal surgery or ophthalmic laser treatment or recent (within 6 months) history of, or evidence of, corneal defects, corneal ulcerations, keratitis, or keratoconus, or other known abnormalities of the cornea that may pose an increased risk of developing a corneal ulcer prior/concomitant therapy\n8. Prior treatment with any investigational selective inhibitor of the fibroblast growth factor (FGF)/FGF receptor pathway (unless approved standard of care for tumor indication).'}, 'identificationModule': {'nctId': 'NCT05325866', 'acronym': 'FORTITUDE-301', 'briefTitle': 'A Study Evaluating Bemarituzumab in Solid Tumors With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amgen'}, 'officialTitle': 'A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression (FORTITUDE-301)', 'orgStudyIdInfo': {'id': '20210104'}, 'secondaryIdInfos': [{'id': '2023-505455-44', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Monotherapy Dose Exploration', 'description': 'Participants across multiple primary epithelial solid tumors with centrally determined FGFR2b overexpression and relapsed/refractory unresectable and/or metastatic disease will receive 1 of 2 dose regimens of bemarituzumab to determine recommended Phase 2 dose.', 'interventionNames': ['Drug: Bemarituzumab']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2: Monotherapy Dose Expansion', 'description': 'Participants across multiple primary epithelial solid tumors with centrally determined FGFR2b overexpression and relapsed/refractory unresectable and/or metastatic disease will receive the dose of bemarituzumab identified as the recommended Phase 2 dose during Part 1.', 'interventionNames': ['Drug: Bemarituzumab']}], 'interventions': [{'name': 'Bemarituzumab', 'type': 'DRUG', 'otherNames': ['AMG 552'], 'description': 'Intravenous (IV) infusion.', 'armGroupLabels': ['Part 1: Monotherapy Dose Exploration', 'Part 2: Monotherapy Dose Expansion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Community Health Network MD Anderson Cancer Center - North', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'United States Oncology Regulatory Affairs Corporate Office', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology - Dallas Fort Worth', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75063', 'city': 'Irving', 'state': 'Texas', 'country': 'United States', 'facility': 'US Oncology Research Investigational Products Center', 'geoPoint': {'lat': 32.81402, 'lon': -96.94889}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology Northeast Texas', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': 'C1426ANZ', 'city': 'Capital Federal', 'state': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Instituto Alexander Fleming'}, {'zip': 'C1118AAT', 'city': 'Ciudad Autonoma de Buenos Aires', 'state': 'Buenos 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115.83757}}, {'zip': '8036', 'city': 'Graz', 'country': 'Austria', 'facility': 'Medizinische Universitaet Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}, {'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'Landeskrankenhaus Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universite Catholique de Louvain Cliniques Universitaires Saint Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '6060', 'city': 'Charleroi', 'country': 'Belgium', 'facility': 'Grand Hopital de Charleroi - Site des Viviers', 'geoPoint': {'lat': 50.41136, 'lon': 4.44448}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Leuven - Campus Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'Hospital das Clinicas da Ufmg', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '80440-220', 'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'facility': 'Centro de Oncologia Mackenzie', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'zip': '90035-001', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Associacao Hospitalar Moinhos de Vento', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '01221-020', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Cancer Arnaldo Vieira de Carvalho', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': '01323-900', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 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'country': 'Czechia', 'facility': 'Fakultni nemocnice Kralovske Vinohrady', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '2100', 'city': 'København Ø', 'country': 'Denmark', 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.70968, 'lon': 12.56862}}, {'zip': '00180', 'city': 'Helsinki', 'country': 'Finland', 'facility': 'Docrates Syopasairaala', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '49055', 'city': 'Angers', 'country': 'France', 'facility': 'Institut de Cancerologie de l Ouest Rene Gauducheau', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'Centre Hospitalier Regional Universitaire de Besancon - Hopital Jean Minjoz', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13272', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Institut regional du Cancer Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Hopital Lyon sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Universitaire du Cancer Toulouse Oncopole', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'Sotiria General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '11528', 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'facility': 'Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amgen'}]}, 'ipdSharingStatementModule': {'url': 'http://www.amgen.com/datasharing', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2 ) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.', 'ipdSharing': 'YES', 'description': 'De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.', 'accessCriteria': 'Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amgen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}