Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-01-14 @ 12:07 PM
Study NCT ID:
NCT03637868
Status:
WITHDRAWN
Last Update Posted:
2020-05-06
First Post:
2018-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eribulin in Brain Metastases From HER2-negative Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], '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': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C490954', 'term': 'eribulin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective, national, multicenter, open-label, uncontrolled, multi-cohort phase II trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-05', 'studyFirstSubmitDate': '2018-08-06', 'studyFirstSubmitQcDate': '2018-08-16', 'lastUpdatePostDateStruct': {'date': '2020-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Progression-free survival for non-CNS disease', 'timeFrame': 'from Eribulin initiation until the date of first documented extra-cranial disease progression or date of death from any cause - up to 28 months', 'description': 'Extracranial progression-free survival will be defined as the time from Eribulin initiation to disease progression according to RECIST 1.1 criteria (Schwartz et al. 2016) or death from any cause. Thoracic and abdominal CT-scans will be performed as recommended in each participating center (usually every 6 weeks) to assess non CNS disease (extracranial PFS, non-CNS response rate, and clinical benefit). Non-CNS disease will be evaluated according to investigator assessment.'}, {'measure': 'Bi-compartmental progression-free survival (PFS)', 'timeFrame': 'from Eribulin initiation until the date of first documented progression or date of death from any cause - up to 28 months', 'description': 'Bi-compartmental PFS will be defined as the time from Eribulin initiation to CNS disease progression according to RANO-BM criteria or non-CNS disease progression according to RECIST 1.1 criteria or death from any cause'}, {'measure': 'Overall response rate for extra-CNS disease', 'timeFrame': 'from Eribulin initiation until 30 days after completion of treatment', 'description': 'The overall response rate for non-CNS disease will be defined as the rate of patients with a partial response or a complete response according to RECIST 1.1 criteria'}, {'measure': 'Clinical benefit for both CNS and extra-CNS disease', 'timeFrame': 'partial response or complete response or disease stabilization > 6 months', 'description': 'The clinical benefit rate will be defined as the rate of patients with a partial response or a complete response or disease stabilization \\> 6 months. Clinical benefit will be assessed for both CNS (using RANO-BM criteria) and non-CNS disease (using RECIST 1.1 criteria), separately'}, {'measure': 'Eribulin efficacy according to hormone receptors expression', 'timeFrame': 'from Eribulin initiation until 30 days after completion of treatment', 'description': 'CNS objective response rates will be assessed according to hormone receptors expression (positive vs negative). A case will be defined as hormone receptors negative if both estrogen receptor and progesterone receptor expression are expressed by less than 10% of tumor cells'}, {'measure': 'Efficacy comparison between patients with and without non-CNS disease', 'timeFrame': 'from Eribulin initiation until 30 days after completion of treatment', 'description': "CNS objective response rates will be assessed according the presence of non-CNS disease ('CNS only' vs 'not CNS only')."}], 'primaryOutcomes': [{'measure': 'Efficacy of eribulin for treatment of HER2-negative BCBM', 'timeFrame': 'from inclusion until 30 days after completion of treatment', 'description': 'By estimating central nervous system (CNS) objective response rate per RANO-BM criteria. CNS objective response rate will be defined as the rate of patients with a partial response or a complete response as defined by RANO-BM criteria (Lin et al. 2015)'}], 'secondaryOutcomes': [{'measure': 'Safety of Eribulin in this population', 'timeFrame': 'from Eribulin initiation until 30 days after completion of treatment', 'description': 'Toxicity will be evaluated before every chemotherapy infusion according to NCI CTCAE v5.0 criteria. All treatment-related adverse events will be collected. The rate of grade 3 to 5 adverse events will be analyzed'}, {'measure': 'Time to WBRT (cohort A and B)', 'timeFrame': 'from Eribulin initiation to the time of the first dose of whole brain radiation therapy - up to 28 months', 'description': 'Time to WBRT will be defined as the time from Eribulin initiation to WBRT start'}, {'measure': 'CNS progression-free survival', 'timeFrame': 'from Eribulin initiation until the date of first documented CNS disease progression or date of death from any cause - up to 28 months', 'description': 'CNS progression-free survival will be defined as the time from Eribulin initiation to CNS disease progression according to RANO-BM criteria or death from any cause'}, {'measure': 'Overall survival', 'timeFrame': 'from Eribulin initiation to death', 'description': 'Overall survival will be defined as the time from Eribulin initiation to death from any cause'}, {'measure': 'Change in cognitive function', 'timeFrame': 'From Eribulin initiation up to 7 days after study treatment discontinuation', 'description': 'Cognitive function will be evaluated by self-report Fact-Cog v3.0 questionnaires (French validated version;(Joly et al. 2012)) that will have to be filled every two cycles (before every day 1 infusion)'}, {'measure': 'Quality of life measured by Functional Assessment of Cancer Therapy-Brain Metastasis', 'timeFrame': 'From Eribulin initiation up to 7 days after study treatment discontinuation', 'description': 'Quality of life will be measured by Functional Assessment of Cancer Therapy-Brain Metastasis (FACT-Br v4.0, (Thavarajah et al. 2014)) questionnaire. This questionnaire will be filled every two cycles'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER2-negative breast cancer', 'brain metastases'], 'conditions': ['Metastatic Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '25032884', 'type': 'BACKGROUND', 'citation': 'Arslan C, Dizdar O, Altundag K. Chemotherapy and biological treatment options in breast cancer patients with brain metastasis: an update. Expert Opin Pharmacother. 2014 Aug;15(12):1643-58. doi: 10.1517/14656566.2014.929664.'}, {'pmid': '17609666', 'type': 'BACKGROUND', 'citation': 'Bart J, Nagengast WB, Coppes RP, Wegman TD, van der Graaf WT, Groen HJ, Vaalburg W, de Vries EG, Hendrikse NH. Irradiation of rat brain reduces P-glycoprotein expression and function. Br J Cancer. 2007 Aug 6;97(3):322-6. doi: 10.1038/sj.bjc.6603864. Epub 2007 Jul 3.'}, {'pmid': '16959347', 'type': 'BACKGROUND', 'citation': 'Bartsch R, Fromm S, Rudas M, Wenzel C, Harbauer S, Roessler K, Kitz K, Steger GG, Weitmann HD, Poetter R, Zielinski CC, Dieckmann K. Intensified local treatment and systemic therapy significantly increase survival in patients with brain metastases from advanced breast cancer - a retrospective analysis. Radiother Oncol. 2006 Sep;80(3):313-7. doi: 10.1016/j.radonc.2006.08.001. Epub 2006 Sep 7.'}, {'pmid': '26052228', 'type': 'BACKGROUND', 'citation': 'Chang AY, Ying XX. Brain Metastases from Breast Cancer and Response to Treatment with Eribulin: A Case Series. Breast Cancer (Auckl). 2015 May 24;9:19-24. doi: 10.4137/BCBCR.S21176. eCollection 2015.'}, {'pmid': '21376385', 'type': 'BACKGROUND', 'citation': "Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2."}, {'pmid': '19509144', 'type': 'BACKGROUND', 'citation': 'Jimeno A. Eribulin: rediscovering tubulin as an anticancer target. Clin Cancer Res. 2009 Jun 15;15(12):3903-5. doi: 10.1158/1078-0432.CCR-09-1023. Epub 2009 Jun 9.'}, {'pmid': '22549504', 'type': 'BACKGROUND', 'citation': 'Joly F, Lange M, Rigal O, Correia H, Giffard B, Beaumont JL, Clisant S, Wagner L. French version of the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) version 3. Support Care Cancer. 2012 Dec;20(12):3297-305. doi: 10.1007/s00520-012-1439-2. Epub 2012 May 2.'}, {'pmid': '16020666', 'type': 'BACKGROUND', 'citation': 'Jordan MA, Kamath K, Manna T, Okouneva T, Miller HP, Davis C, Littlefield BA, Wilson L. The primary antimitotic mechanism of action of the synthetic halichondrin E7389 is suppression of microtubule growth. Mol Cancer Ther. 2005 Jul;4(7):1086-95. doi: 10.1158/1535-7163.MCT-04-0345.'}, {'pmid': '25605862', 'type': 'BACKGROUND', 'citation': 'Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J. Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2015 Feb 20;33(6):594-601. doi: 10.1200/JCO.2013.52.4892. Epub 2015 Jan 20.'}, {'pmid': '26065612', 'type': 'BACKGROUND', 'citation': 'Lin NU, Lee EQ, Aoyama H, Barani IJ, Barboriak DP, Baumert BG, Bendszus M, Brown PD, Camidge DR, Chang SM, Dancey J, de Vries EG, Gaspar LE, Harris GJ, Hodi FS, Kalkanis SN, Linskey ME, Macdonald DR, Margolin K, Mehta MP, Schiff D, Soffietti R, Suh JH, van den Bent MJ, Vogelbaum MA, Wen PY; Response Assessment in Neuro-Oncology (RANO) group. Response assessment criteria for brain metastases: proposal from the RANO group. Lancet Oncol. 2015 Jun;16(6):e270-8. doi: 10.1016/S1470-2045(15)70057-4. Epub 2015 May 27.'}, {'pmid': '19470768', 'type': 'BACKGROUND', 'citation': 'Lu J, Steeg PS, Price JE, Krishnamurthy S, Mani SA, Reuben J, Cristofanilli M, Dontu G, Bidaut L, Valero V, Hortobagyi GN, Yu D. Breast cancer metastasis: challenges and opportunities. Cancer Res. 2009 Jun 15;69(12):4951-3. doi: 10.1158/0008-5472.CAN-09-0099. Epub 2009 May 26. No abstract available.'}, {'pmid': '24350786', 'type': 'BACKGROUND', 'citation': 'Matsuoka H, Tsurutani J, Tanizaki J, Iwasa T, Komoike Y, Koyama A, Nakagawa K. Regression of brain metastases from breast cancer with eribulin: a case report. BMC Res Notes. 2013 Dec 18;6:541. doi: 10.1186/1756-0500-6-541.'}, {'pmid': '21324687', 'type': 'BACKGROUND', 'citation': 'Narayan S, Carlson EM, Cheng H, Condon K, Du H, Eckley S, Hu Y, Jiang Y, Kumar V, Lewis BM, Saxton P, Schuck E, Seletsky BM, Tendyke K, Zhang H, Zheng W, Littlefield BA, Towle MJ, Yu MJ. Novel second generation analogs of eribulin. Part III: Blood-brain barrier permeability and in vivo activity in a brain tumor model. Bioorg Med Chem Lett. 2011 Mar 15;21(6):1639-43. doi: 10.1016/j.bmcl.2011.01.096. Epub 2011 Jan 26.'}, {'pmid': '27177860', 'type': 'BACKGROUND', 'citation': 'Pivot X, Marme F, Koenigsberg R, Guo M, Berrak E, Wolfer A. Pooled analyses of eribulin in metastatic breast cancer patients with at least one prior chemotherapy. Ann Oncol. 2016 Aug;27(8):1525-31. doi: 10.1093/annonc/mdw203. Epub 2016 May 13.'}, {'pmid': '2262373', 'type': 'BACKGROUND', 'citation': 'Qin DX, Zheng R, Tang J, Li JX, Hu YH. Influence of radiation on the blood-brain barrier and optimum time of chemotherapy. Int J Radiat Oncol Biol Phys. 1990 Dec;19(6):1507-10. doi: 10.1016/0360-3016(90)90364-p.'}, {'pmid': '27189322', 'type': 'BACKGROUND', 'citation': 'Schwartz LH, Litiere S, de Vries E, Ford R, Gwyther S, Mandrekar S, Shankar L, Bogaerts J, Chen A, Dancey J, Hayes W, Hodi FS, Hoekstra OS, Huang EP, Lin N, Liu Y, Therasse P, Wolchok JD, Seymour L. RECIST 1.1-Update and clarification: From the RECIST committee. Eur J Cancer. 2016 Jul;62:132-7. doi: 10.1016/j.ejca.2016.03.081. Epub 2016 May 14.'}, {'pmid': '24287508', 'type': 'BACKGROUND', 'citation': 'Thavarajah N, Bedard G, Zhang L, Cella D, Beaumont JL, Tsao M, Barnes E, Danjoux C, Sahgal A, Soliman H, Chow E. Psychometric validation of the functional assessment of cancer therapy--brain (FACT-Br) for assessing quality of life in patients with brain metastases. Support Care Cancer. 2014 Apr;22(4):1017-28. doi: 10.1007/s00520-013-2060-8. Epub 2013 Nov 28.'}, {'pmid': '8780389', 'type': 'BACKGROUND', 'citation': 'Toth K, Vaughan MM, Peress NS, Slocum HK, Rustum YM. MDR1 P-glycoprotein is expressed by endothelial cells of newly formed capillaries in human gliomas but is not expressed in the neovasculature of other primary tumors. Am J Pathol. 1996 Sep;149(3):853-8.'}, {'pmid': '1443046', 'type': 'BACKGROUND', 'citation': 'Zhang RD, Price JE, Fujimaki T, Bucana CD, Fidler IJ. Differential permeability of the blood-brain barrier in experimental brain metastases produced by human neoplasms implanted into nude mice. Am J Pathol. 1992 Nov;141(5):1115-24.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy of eribulin for treatment of HER2-negative breast cancer brain metastases (BCBM)', 'detailedDescription': 'This study will explore eribulin in three specific cohorts of patients with HER2-negative metastatic breast cancer harboring BCBM, pretreated with anthracyclines and taxanes:\n\n* Cohort A = Newly diagnosed, untreated BCBM, not candidate to initial surgery or stereotactic radiosurgery (SRS) and with pauci-symptomatic disease not requiring immediate whole-brain radiation therapy (WBRT)\n* Cohort B = BCBM pretreated with SRS and/or surgery alone, without WBRT, and not requiring immediate WBRT\n* Cohort C = BCBM pretreated with WBRT'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 18 years of age.\n2. Life expectancy of 3 months or longer.\n3. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2.\n4. HER2-negative (IHC 0/1+ or 2+ and in situ hybridization negative) metastatic breast cancer\n5. Locally advanced or metastatic breast cancer that have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. (no limit to the number of previous lines of therapy, no need for extracranial disease)\n6. At least 2 weeks washout period post chemotherapy, targeted or biologic therapy, or radiation therapy is required prior to study entry\n7. Patient with untreated CNS disease or previous SRS/surgery without WBRT (cohorts A and B)\n\n * At least 1 measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI, OR\n * At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two additional CNS tumors measuring ≥ 3 mm in longest diameter, for which the sum of the longest diameters is ≥ 10 mm.\n8. Patient with progressive disease harboring brain metastases after previous WBRT (cohort C)\n\n * At least 1 measurable CNS lesion ≥ 10 mm on T1-weighted gadolinium-enhanced MRI, OR\n * At least one CNS tumor measuring 5-9 mm in longest diameter, plus one or two additional CNS tumors measuring ≥ 3 mm in longest diameter, for which the sum of the longest diameters is ≥ 10 mm.\n9. Adequate organ function as evidenced by:\n\n * Absolute neutrophil count (ANC) ≥ 1.5 x 10e9/L without granulocyte-colony-stimulating factor G-CSF (filgrastim, pegfilgrastim, or equivalent) support within 7 days\n * Hemoglobin (Hgb) ≥ 9.0 g/dL (90 g/L) without blood transfusion within 7 days\n * Platelet count ≥ 100 x 10e9/L without platelet transfusion within 7 days\n * Bilirubin ≤ 1.5 X upper limit of normal (ULN), except for patients with documented history of Gilbert\'s disease who may have DIRECT bilirubin ≤ 1.5 X ULN\n * Alanine aminotransferase (ALT) ≤ 2.5 X ULN, except ≤ 5 X ULN for patients with liver metastases\n * Aspartate aminotransferase (AST) ≤ 2.5 X ULN, except ≤ 5 X ULN for patients with liver metastases\n * Serum creatinine ≤ 1.5 X ULN; or calculated creatinine clearance ≥ 50 mL/min (using MDRD formula), or measured creatinine clearance ≥ 50 mL/min\n\nExclusion Criteria:\n\n1. Prior therapy with eribulin.\n2. Patients should not have had major surgery or radiotherapy (therapeutic and/or palliative) within 14 days prior to initiation of study treatment, including CNS-directed radiation therapy. (Minor procedures, such as tumor biopsy, thoracentesis, or intravenous catheter placement are allowed with no waiting period)\n3. Patients may not have the following co morbid disease or concurrent illness:\n\n * Known cirrhosis, defined as Child Pugh class A or higher liver disease\n * Other active malignancy, except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder)\n * Any other severe/uncontrolled inter current illness or significant co morbid conditions that in the opinion of the investigator would impair study participation or cooperation\n * Patients with the presence of an active infection, abscess or fistula\n * Known leptomeningeal disease or CNS midline shifts.\n * Any evidence of severe or uncontrolled systemic disease such as clinically significant cardiovascular, pulmonary, hepatic, renal or metabolic disease.\n * Severe conduction abnormality including significant corrected QT interval QTc prolongation \\>450ms.\n * Patients with grade 3/4 peripheral neuropathy.\n4. Patient candidate to SRS and or surgical resection\n5. Major clinical symptoms requiring immediate WBRT as defined by "local tumor board"\n6. Increase in corticosteroid dose in the week prior to baseline brain MRI\n7. Patients with pacemaker or implantable cardioverter-defibrillator devices incompatible with MRI assessment.\n8. Contraindication to Gadolinium infusion.\n9. Treatment ongoing with other chemotherapy, hormonal therapy, immunotherapy, other investigational agents, or biologic agents for the treatment of cancer except bisphosphonates or denosumab.\n10. Pregnant or breast-feeding patients\n11. Women of child-bearing potential without effective contraception method.\n12. Patient unable to express their consent.'}, 'identificationModule': {'nctId': 'NCT03637868', 'acronym': 'ERIBRAIN', 'briefTitle': 'Eribulin in Brain Metastases From HER2-negative Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'A Phase II Study of Eribulin in Brain Metastases From HER2-negative Breast Cancer Pre-treated With Anthracyclines and Taxanes', 'orgStudyIdInfo': {'id': 'ERIBRAIN-IPC 2017-014'}, 'secondaryIdInfos': [{'id': '2018-001027-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eribulin', 'description': 'eribulin 1.4 mg/m² administered intravenously between 6 and 7 cycles.', 'interventionNames': ['Drug: Eribulin']}], 'interventions': [{'name': 'Eribulin', 'type': 'DRUG', 'description': 'Patients will receive eribulin 1.4 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.', 'armGroupLabels': ['Eribulin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Angers', 'country': 'France', 'facility': "Institut de Cancerologie de L'Ouest - Paul Papin", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'city': 'Avignon', 'country': 'France', 'facility': 'Institut Sainte Catherine', 'geoPoint': {'lat': 43.94834, 'lon': 4.80892}}, {'city': 'Besançon', 'country': 'France', 'facility': 'CHU Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Institut Du Cancer de Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Saint-Herblain', 'country': 'France', 'facility': "Institut De Cancérologie de l'Ouest", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Institut de Cancerologie de Lorraine Alexis Vautrin', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'Renaud Sabatier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eisai Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}