Ignite Creation Date:
2025-12-24 @ 5:37 PM
Ignite Modification Date:
2026-01-05 @ 5:41 PM
Study NCT ID:
NCT03571568
Status:
RECRUITING
Last Update Posted:
2025-04-24
First Post:
2018-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069283', 'term': 'Rituximab'}, {'id': 'C000604908', 'term': 'acalabrutinib'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Phase 1/2a, dose escalation, consecutive-cohort, open-label study trial of BI-1206 in combination with rituximab with or without Acalabrutinib'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-23', 'studyFirstSubmitDate': '2018-05-17', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2025-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Expression levels of CD32b protein', 'timeFrame': 'Up to 1 year', 'description': 'To investigate CD32b protein expression levels using flow cytometry to evaluate any potential correlation with clinical responses. Change from baseline expression levels will be summarized descriptively by dose cohort and/or response to treatment.'}, {'measure': 'Assessment of Patient Reported Outcomes using the NCI PRO-CTCAE questionnaire', 'timeFrame': 'Up to 1 year', 'description': 'The NCI PRO-CTCAE will be used to evaluate symptomatic toxicities reported by patients. The questionnaire characterizes the frequency, severity, interference, and presence/absence of symptomatic toxicities, all toxicities that can be meaningfully reported from the patient perspective.\n\nResponses are scored from 0 to 4 (or 0/1 for absent/present). Scores for each attribute (frequency, severity and/or interference) will be presented descriptively (e.g. summary statistics or graphical presentations).'}, {'measure': 'Expression levels of CD32b and/or other immunological markers', 'timeFrame': 'Up to 1 year', 'description': 'Perform whole-transcriptome, quantitative polymerase chain reaction (qPCR) and/or IHC analysis of lymph node biopsies to evaluate potential correlation with clinical responses.'}, {'measure': 'Measurement of serum cytokines levels and/or soluble CD32b.', 'timeFrame': 'Up to 1 year', 'description': 'Study the potential cause of infusion related reactions (IRRs), such as cytokine release signs, C-reactive protein (CRP) and/or soluble CD32b.'}], 'primaryOutcomes': [{'measure': 'Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab and/or acalabrutinib', 'timeFrame': 'During the 28-day treatment period on induction therapy', 'description': 'Assess the safety and tolerability profile of BI-1206 when administered intravenously (IV) or subcutaneously (SC) in combination with rituximab or rituximab and acalabrutinib in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL), subtypes follicular lymphoma (FL)(except FL grade 3B), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL). Assessment will be done according to National Cancer Institute (NCI-CTCAE) criteria v. 5.0.'}, {'measure': 'Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or Rituximab-related or possibly related dose-limiting toxicity (DLT)', 'timeFrame': 'During the 28-day treatment period on induction therapy', 'description': 'Phase 1:\n\nSelect the recommended Phase 2 dose (RP2D) by establishing the maximum tolerated dose (MTD) of BI-1206 given once weekly for 4 weeks, via IV infusion or SC injection in combination with rituximab.'}, {'measure': 'Determine the recommended dose of BI-1206 in combination with rituximab and acalabrutinib', 'timeFrame': 'During the 28-day treatment period on induction therapy', 'description': 'Phase 2a:\n\nSelect the recommended dose of BI-1206 in combination with rituximab and acalabrutinib.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of PK parameters for BI-1206', 'timeFrame': 'Up to 1 year', 'description': 'PK parameters assessed will include AUC, Cmax, time to Cmax and t1/2 of BI-1206 when administered IV or SC'}, {'measure': 'Evaluation of ADA (immunogenicity) response to BI-1206', 'timeFrame': 'Up to 1 year', 'description': 'Assess the incidence and titre of antidrug antibodies of BI-1206 in serum when administered IV or SC in combination with rituximab or rituximab and acalabrutinib.'}, {'measure': 'Measurement of peripheral blood B-lymphocytes depletion', 'timeFrame': 'Up to 1 year', 'description': 'Evaluate the effect of BI-1206 administered IV or SC in combination with rituximab or rituximab and acalabrutinib measuring B Lymphocytes CD19+ (absolute value) as part of hematology assessment to determine the level of peripheral blood B lymphocyte depletion.'}, {'measure': 'Assessment of overall response rate (ORR) according to the response criteria for malignant lymphoma (Cheson, 2014).', 'timeFrame': 'Up to 1 year', 'description': 'Assess possible anti-tumor activity of BI-1206 administered IV or SC in combination with rituximab or rituximab and acalabrutinib at Week 6 after first dose of BI-1206 and for subjects who continue during maintenance therapy.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Indolent B-Cell Non-Hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'Phase 1/2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab', 'detailedDescription': 'This is a Phase 1/2a, multicenter, dose escalation, consecutive-cohort, open-label trial of BI-1206 in combination with rituximab with or without acalabrutinib in subjects with indolent relapsed or refractory B-cell NHL, sub-types FL (except FL grade 3B), MZL, and MCL.\n\nPhase 2a, consists of signal seeking cohorts followed by a randomized, parallel, two-arm dose optimization.\n\nThe trial consists of 2 main parts:\n\nPhase 1\n\n\\- Dose Escalation, with two different Arms assessing IV or SC dosing of BI-1206 in combination with rituximab, with dose escalation cohorts and selection of the IV and SC doses of BI-1206 for Phase 2a\n\nPhase 2a\n\n* Dose Expansion, with one expansion cohort evaluating the selected IV dose of BI-1206 in combination with rituximab\n* Signal Seeking, assessing IV and SC dosing of BI-1206 in combination with rituximab and acalabrutinib. The Signal Seeking will consist of a Safety Run-in and an Expansion\n* Dose Optimization to select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Are ≥ 18 years of age by initiation of study treatment.\n2. Have B-cell NHL proven by histology, with histological subtypes limited to follicular lymphoma (FL) (except FL grade 3B), MCL and marginal zone lymphoma (MZL)\n3. Have measurable nodal disease\n4. Are willing to undergo lymph node biopsies or biopsies of other involved tissue\n5. Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists\n6. Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen\n7. Have a life expectancy of at least 12 weeks\n8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n9. Have CD20+ malignancy\n10. Have hematological and biochemical indices within prespecified ranges\n\nExclusion Criteria:\n\n1. Have had an allogenic bone marrow or stem cell transplant within 12 months\n2. Have presence of active chronic graft versus host disease\n3. Have current leptomeningeal lymphoma or compromise of the central nervous system\n4. Have transformed lymphoma from a pre-existing indolent lymphoma\n5. Have Waldenstrom's Macroglobulinemia or FL grade 3B,\n6. Need systemic doses of prednisolone \\>10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as pre-medication.\n7. Have known or suspected hypersensitivity to rituximab or BI-1206\n8. Have cardiac or renal amyloid light-chain amyloidosis\n9. Have received any of the following:\n\n 1. Chemotherapy or small molecule products with 2 weeks of first dose of BI-1206\n 2. Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks\n 3. Immunotherapy within 8 weeks\n 4. Previous lines of treatment containing BTK inhibitors for Subjects receiving BI-1206 in combination with rituximab and acalabrutinib\n10. Have ongoing toxic manifestations of previous treatments.\n11. Have the ability to become pregnant (or already pregnant or lactating/breastfeeding).\n12. Have had major surgery from which the subject has not yet recovered.\n13. Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals.\n14. Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n15. Have an active, known or suspected autoimmune disease.\n16. Have concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association \\[NYHA\\])\n17. Have current malignancies of other types"}, 'identificationModule': {'nctId': 'NCT03571568', 'briefTitle': 'A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL', 'organization': {'class': 'INDUSTRY', 'fullName': 'BioInvent International AB'}, 'officialTitle': 'Phase 1/2a Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab', 'orgStudyIdInfo': {'id': '17-BI-1206-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI-1206 IV Dose Escalation', 'description': 'Standard 3+3 Dose-Escalation of BI-1206 IV in combination with Rituximab', 'interventionNames': ['Biological: BI-1206', 'Biological: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'BI-1206 SC Dose Escalation', 'description': 'Adaptive Dose Escalation of BI-1206 SC (Bayesian logistic regression model (BLRM) in combination with Rituximab', 'interventionNames': ['Biological: BI-1206', 'Biological: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2a IV Dose expansion', 'description': 'BI-1206 IV in Combination with Rituximab', 'interventionNames': ['Biological: BI-1206', 'Biological: Rituximab']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2a SC Signal seeking', 'description': 'SC Arm, BI-1206 in Combination with Rituximab and Acalabrutinib', 'interventionNames': ['Biological: BI-1206', 'Biological: Rituximab', 'Biological: Acalabrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2a IV Signal Seeking', 'description': 'IV Arm, BI-1206 in Combination with Rituximab and Acalabrutinib', 'interventionNames': ['Biological: BI-1206', 'Biological: Rituximab', 'Biological: Acalabrutinib']}], 'interventions': [{'name': 'BI-1206', 'type': 'BIOLOGICAL', 'description': 'BI-1206 150 mg / 225 mg Subcutaneous injection\n\nBI-1206 50 mg /100 mg Intravenous infusion', 'armGroupLabels': ['BI-1206 IV Dose Escalation', 'BI-1206 SC Dose Escalation', 'Phase 2a IV Dose expansion', 'Phase 2a IV Signal Seeking', 'Phase 2a SC Signal seeking']}, {'name': 'Rituximab', 'type': 'BIOLOGICAL', 'otherNames': ['Ruxience'], 'description': 'Rituximab 375 mg/m2, as per SmPC', 'armGroupLabels': ['BI-1206 IV Dose Escalation', 'BI-1206 SC Dose Escalation', 'Phase 2a IV Dose expansion', 'Phase 2a IV Signal Seeking', 'Phase 2a SC Signal seeking']}, {'name': 'Acalabrutinib', 'type': 'BIOLOGICAL', 'otherNames': ['Calquence'], 'description': 'Acalabrutinib 100 mg orally as per SmPC', 'armGroupLabels': ['Phase 2a IV Signal Seeking', 'Phase 2a SC Signal seeking']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Don Stevens, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Salvador', 'state': 'Estado de Bahia', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Cacilda', 'role': 'CONTACT', 'email': 'analuziaschriefer@gmail.com'}, {'name': 'Ana Luiza Schriefer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital São Rafael', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Suellen', 'role': 'CONTACT', 'email': 'fogliattopesquisa@gmail.com'}, {'name': 'Laura Maria Fogliatto, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Curitiba', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'email': 'munhoz.ec@gmail.com'}, {'name': 'Eduardo Munhoz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Rio de Janeiro', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Thaiane Alexandre, RN', 'role': 'CONTACT', 'email': 'thaianealexandre@ruschelmedicina.com.br'}, {'name': 'Rony Schaffel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruschel Medicina e Pesquisa Clínica', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'RN', 'role': 'CONTACT', 'email': 'ana.cordeiro@accamargo.org.br'}, {'name': 'Ana Costa Cordeiro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'A.C. Camargo Cancer Center', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'email': 'pesquisafac.edersonmattos@gmail.com'}, {'name': 'Ederson Roberto De Mattos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Amaral Carvalho', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Camila Hinsching, RN', 'role': 'CONTACT', 'email': 'camila.f@hc.fm.usp.br'}, {'name': 'Juliana Pereira, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'RN', 'role': 'CONTACT', 'email': 'guiperini@gmail.com'}, {'name': 'Guilherme Perini, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Israelita Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'email': 'carlos.chiattone@terra.com.br'}, {'name': 'Carlos Chiattone, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Samaritano', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'status': 'NOT_YET_RECRUITING', 'country': 'Brazil', 'contacts': [{'role': 'CONTACT', 'email': 'anaritafonsecabm@gmail.com'}, {'name': 'Ana Rita Da Fonseca, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Sírio-Libanês', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'Frankfurt am Main', 'state': 'Hesse', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'role': 'CONTACT', 'email': 'weidmann.eckhart@khnw.de'}, {'name': 'Eckhart Weidmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Krankenhaus Nordwest Klinik für Onkologie und Hämatologie', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}, {'city': 'Stuttgart', 'status': 'WITHDRAWN', 'country': 'Germany', 'facility': 'Robert Bosch Hospital, Dep of Hematology, Oncology and Palliative care', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}, {'zip': '86-300', 'city': 'Grudziądz', 'status': 'TERMINATED', 'country': 'Poland', 'facility': 'Szpital Specjlistyczny', 'geoPoint': {'lat': 53.48411, 'lon': 18.75366}}, {'city': 'Krakow', 'status': 'TERMINATED', 'country': 'Poland', 'facility': 'Małopolskie Centrum Medyczne', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'email': 'jsancho@iconcologia.net'}, {'name': 'Juan Manuel Sancho Cia, MA', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital ICO, Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'email': 'smiqueleiz@santpau.cat'}, {'name': 'Sara Miqueleiz Alamos, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de la Santa Creu i Sant Pau, Dep Hematologia', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'email': 'pabrisqueta@vhio.net'}, {'name': 'Pablo Abrisqueta Costa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'email': 'edomingo@iconcologia.net'}, {'name': 'Eva Domingo Domenech, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Institut Català d'Oncologia, L'Hospitalet de Llobregat", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'email': 'bastosmariana@yahoo.com'}, {'name': 'Mariana Bastos Oreiro, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital General Universitario Gregorio Marañon-Oncología Médica', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Agustín Penedo Coello', 'role': 'CONTACT', 'email': 'apenedo@hmhospitales.com'}, {'name': 'Augustin Penedo Coello, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario HM Sanchinarro', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'email': 'raul.cordoba@fjd.es'}, {'name': 'Raul Cordoba Mascunano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital Fundacion Jimenez Diaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Murcia', 'status': 'NOT_YET_RECRUITING', 'country': 'Spain', 'contacts': [{'role': 'CONTACT', 'email': 'joaquingomezespuch@hotmail.com'}, {'name': 'Joaquin Gomez Espuch, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen de la Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Sergio Ortegón Alcaide', 'role': 'CONTACT', 'email': 'sortegonalcaide@gmail.com'}, {'name': 'Sergio Ortegon Alcaide, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital University Virgen Macarene', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': 'SE-22185', 'city': 'Lund', 'status': 'TERMINATED', 'country': 'Sweden', 'facility': 'Department of Oncology, Skåne University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': '751 85', 'city': 'Uppsala', 'status': 'TERMINATED', 'country': 'Sweden', 'facility': 'Department of Oncology, Academical Hospital', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}], 'centralContacts': [{'name': 'Erika Bågeman', 'role': 'CONTACT', 'email': 'erika.bageman@bioinvent.com', 'phone': '+46706126618'}, {'name': 'Andres McAllister, MD, PhD', 'role': 'CONTACT', 'email': 'andres.mcallister@bioinvent.com'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'Within one year from end of study', 'ipdSharing': 'YES', 'description': 'All information concerning the product as well as any matter concerning the operation of the Sponsor, such as clinical indications for the drug, its formula, methods of manufacture and other scientific data relating to it, that have been provided by the Sponsor and are unpublished, are confidential and must remain the sole property of the Sponsor. The Investigator will agree to use the information only for the purposes of carrying out this study and for no other purpose unless prior written permission from the Sponsor is obtained.', 'accessCriteria': 'Paper copy of CSR'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BioInvent International AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}