Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-01-03 @ 11:05 PM
Study NCT ID:
NCT02751918
Status:
COMPLETED
Last Update Posted:
2019-11-22
First Post:
2016-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France', 'Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000595240', 'term': 'anetumab ravtansine'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2016-04-22', 'studyFirstSubmitQcDate': '2016-04-22', 'lastUpdatePostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) of Anetumab ravtansine in combination with pegylated liposomal doxorubicin when given every three weeks', 'timeFrame': 'Up to 6 months, minimum: 1 cycle (=21days)', 'description': 'MTD is defined as the highest dose of anetumab ravtansine administered in combination with pegylated liposomal doxorubicin that can be given such that not more than 1 of 6 subjects at a given dose level experiences a dose-limiting toxicity (DLT).'}, {'measure': 'Incidence of serious and non-serious adverse events (AEs)', 'timeFrame': 'Up to 6 months'}], 'secondaryOutcomes': [{'measure': 'AUC (area under the plasma concentration vs. time curve from zero to infinity after single (first) dose) of Anetumab ravtansine analytes (Antibody drug conjugates, Total Antibody, metabolites DM4, and DM4-Me)', 'timeFrame': 'At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 24h, 48h, 168h, 336h and 504h post-dose, beginning on day 1 of cycle 1'}, {'measure': 'AUC(0-tlast) (AUC from time zero to the last data point > lower limit of quantification) of Anetumab ravtansine analytes (Antibody drug conjugates, Total Antibody, metabolites DM4, and DM4-Me)', 'timeFrame': 'At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 24h, 48h, 168h, 336h and 504h post-dose, beginning on day 1 of cycle 1'}, {'measure': 'Cmax (maximum drug concentration in plasma after first dose administration) of Anetumab ravtansine analytes (Antibody drug conjugates, Total Antibody, metabolites DM4, and DM4-Me)', 'timeFrame': 'At pre-dose, 0.5h, 1h, 1.5h, 2h, 3h, 5h, 8h, 24h, 48h, 168h, 336h and 504h post-dose, beginning on day 1 of cycle 1'}, {'measure': 'AUC of total pegylated liposomal doxorubicin', 'timeFrame': 'At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose , beginning on day 1 of cycle 1'}, {'measure': 'AUC(0-tlast) of total pegylated liposomal doxorubicin', 'timeFrame': 'At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose , beginning on day 1 of cycle 1'}, {'measure': 'Cmax of total pegylated liposomal doxorubicin', 'timeFrame': 'At pre-dose, 0.5h, 1h, 2h, 3h, 6h, 8h, 22h, 46h, and 166h post-dose, beginning on day 1 of cycle 1'}, {'measure': 'Incidence of patients with CR, PR, SD or PD according to RECIST 1.1', 'timeFrame': 'Up to 17 months or until discontinuation of study, whichever comes first', 'description': 'CR (complete response) PR (partial response) SD (stable disease) PD (progressive disease)'}, {'measure': 'Incidence of positive anti-drug antibody titer', 'timeFrame': 'Up to 17 months or until discontinuation of study, whichever comes first'}, {'measure': 'Incidence of positive neutralizing antibody titer', 'timeFrame': 'Up to 17 months or until discontinuation of study, whichever comes first'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mesothelin-expressing platinum-resistant cancer'], 'conditions': ['Ovarian Neoplasms']}, 'referencesModule': {'references': [{'pmid': '36564099', 'type': 'DERIVED', 'citation': 'Santin AD, Vergote I, Gonzalez-Martin A, Moore K, Oaknin A, Romero I, Diab S, Copeland LJ, Monk BJ, Coleman RL, Herzog TJ, Siegel J, Kasten L, Schlicker A, Schulz A, Kochert K, Walter AO, Childs BH, Elbi C, Bulat I. Safety and activity of anti-mesothelin antibody-drug conjugate anetumab ravtansine in combination with pegylated-liposomal doxorubicin in platinum-resistant ovarian cancer: multicenter, phase Ib dose escalation and expansion study. Int J Gynecol Cancer. 2023 Apr 3;33(4):562-570. doi: 10.1136/ijgc-2022-003927.'}]}, 'descriptionModule': {'briefSummary': 'Anetumab ravtansine is developed for the treatment of patients with recurrent platinum-resistant ovarian cancer. The purpose of the proposed trial is to identify the maximum tolerated dose of anetumab ravtansine that could be safely combined with pegylated liposomal doxorubicin in this indication.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with locally invasive or metastatic, epithelial ovarian, fallopian tube, or primary peritoneal cancer\n* Subjects must provide samples of tumor tissue\n* Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n\nExclusion Criteria:\n\n* Subjects with low-grade ovarian, fallopian tube, or Primary peritoneal cancer\n* Women who are pregnant or breast feeding\n* Subjects who have an active hepatitis B virus or hepatitis C virus infection requiring treatment as defined in the protocol'}, 'identificationModule': {'nctId': 'NCT02751918', 'briefTitle': 'Phase Ib Study of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin in Patients With Recurrent Mesothelin-expressing Platinum-resistant Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Open-label Phase Ib Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Maximum Tolerated Dose of Anetumab Ravtansine in Combination With Pegylated Liposomal Doxorubicin 30 mg/m2 Given Every 3 Weeks in Subjects With Mesothelin-expressing Platinum-resistant Recurrent Ovarian, Fallopian Tube or Primary Peritoneal Cancer', 'orgStudyIdInfo': {'id': '18326'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anetumab ravtansine', 'description': 'Anetumab ravtansine in combination with pegylated liposomal doxorubicin in subjects with mesothelin-expressing platinum-resistant recurrent ovarian, fallopian tube, or primary peritoneal cancer. Increase/Decrease of Anetumab ravtansine until maximum tolerated dose identified.', 'interventionNames': ['Drug: Anetumab ravtansine (BAY94-9343)', 'Drug: Pegylated Liposomal Doxorubicin']}], 'interventions': [{'name': 'Anetumab ravtansine (BAY94-9343)', 'type': 'DRUG', 'description': 'Anetumab ravtansine will be administered on Day 1 of every 21-day treatment cycle.', 'armGroupLabels': ['Anetumab ravtansine']}, {'name': 'Pegylated Liposomal Doxorubicin', 'type': 'DRUG', 'description': 'Pegylated liposomal doxoribicin will be administered on Day 1 of every 21-day treatment cycle.', 'armGroupLabels': ['Anetumab ravtansine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80012', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rocky Mountain Cancer Centers', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06520-8064', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University School of Medicine', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma University Health Science Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'UZ Leuven Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2025', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'The Institute of Oncology', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Ciutat Sanitària i Universitaria de la Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28027', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinica Universidad de Navarra CUN en Madrid', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clínica Universidad de Navarra CUN', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Instituto Valenciano de Oncología', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}