Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-06 @ 8:33 PM
Study NCT ID:
NCT00635193
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2008-03-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C516631', 'term': 'volociximab'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'dispFirstSubmitDate': '2012-05-04', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-10', 'studyFirstSubmitDate': '2008-03-05', 'dispFirstSubmitQcDate': '2012-05-10', 'studyFirstSubmitQcDate': '2008-03-12', 'dispFirstPostDateStruct': {'date': '2012-05-14', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the efficacy of volociximab in combination with liposomal doxorubicin in advanced epithelial ovarian cancer or primary peritoneal cancer. To evaluate the safety and tolerability of volociximab in combination with liposomal doxorubicin.', 'timeFrame': '50-57 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ovarian neoplasms', 'Angiogenesis inhibitors', 'Angiogenesis', 'Volociximab', 'Ovarian cancer', 'Antibody', 'Monoclonals'], 'conditions': ['Ovarian Cancer, Primary Peritoneal Cancer']}, 'referencesModule': {'references': [{'pmid': '37407274', 'type': 'DERIVED', 'citation': 'Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.'}]}, 'descriptionModule': {'briefSummary': "This is an open-label study of liposomal doxorubicin with or without volociximab for the treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with a surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy in terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft models. In clinical studies, volociximab has been evaluated in several solid tumor types, including pancreatic, renal, and melanoma, with many subjects who entered the studies with progressive disease remaining progression-free for several months. In all studies in solid tumors, volociximab has shown a favorable safety profile when administered at 10 mg/kg q2wks and more recently at 15 mg/kg qwk. A study of volociximab in combination with liposomal doxorubicin in subjects with ovarian cancer or primary peritoneal cancer who have relapsed after prior platin/taxane therapies is warranted to further evaluate the drug's efficacy and safety. The investigators have thus far activated stage 2 of this study at 11/25 sites. Worldwide, the study aims to enroll 150 subjects.", 'detailedDescription': 'This is an open-label study of liposomal doxorubicin with or without volociximab for the treatment of subjects with advanced epithelial ovarian cancer or primary peritoneal cancer relapsed after prior therapy with Plat/Taxane-based chemo. Volociximab is an anti-angiogenic integrin inhibitor being developed for the treatment of solid tumors. Preclinical data with a surrogate volociximab antibody administered as monotherapy indicate encouraging efficacy in terms of tumor reduction and anti-angiogenic effects in mouse ovarian cancer xenograft models. In clinical studies, volociximab has been evaluated in several solid tumor types, including pancreatic, renal, and melanoma, with many subjects who entered the studies with progressive disease remaining progression-free for several months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Females aged \\>= 18 years old at the time of informed consent.\n* Advanced (Stage III or IV) histologically documented epithelial ovarian cancer or primary peritoneal cancer (excluding small, round-cell histologies).\n* Recurrent or persistent disease.\n* Received no more than 2 prior cancer treatment regimens, at least one of which must have included a platinum/taxane based therapy. If the same regimen is given more than once, it will count as one regimen. If components of a regimen are given more than once using the same schedule, it will count as one regimen.\n* At least 1 target lesion to assess response by RECIST criteria. (Tumors within a previously irradiated field are designated as non-target)\n* Other protocol-defined inclusion criteria apply.\n\nExclusion Criteria:\n\n* Subjects taking immunomodulatory agents including, but not limited to, interferons, interleukins, systemic steroids, cyclosporine, tacrolimus, calcineurin inhibitors, chronic low dose methotrexate, or azathioprine. (Use of inhaled or intranasal steroids or oral steroids 10 mg/day prednisone or its equivalent are permitted.)\n* Subjects who require treatment with an anti coagulant with the exception of low dose Aspirin® (81 mg/day), warfarin (1 mg/day), or heparin for IV catheter patency\n* Evidence of bleeding diathesis or coagulopathy. (Prior history of DVT will not exclude subjects from participating in this study.)\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 1.\n* Non-healing wound, ulcer, or bone fracture.\n* Evidence of autoimmune disease including, but not limited to, ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, and other disease in which immune function or immune competence is known to be impaired.\n* Active infection requiring systemic antibiotics, antivirals, or antifungals including HIV/AIDS, hepatitis B, or hepatitis C infection.\n* Other protocol-defined exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT00635193', 'briefTitle': 'Efficacy and Safety Study of M200(Volociximab in Combination With Liposomal Doxorubicin)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Phase 1/2, Open-Label, Adaptive, Randomized Study of Liposomal Doxorubicin With or Without M200 (Volociximab) for the Treatment of Subjects With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer That Have Relapsed After Prior Therapy With a Platinum/Taxane-Based Chemotherapy', 'orgStudyIdInfo': {'id': '206OC202'}, 'secondaryIdInfos': [{'id': '2007-000509-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cohort 1', 'description': 'Three subjects will be treated with liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab, 7.5 mg/kg qwk', 'interventionNames': ['Drug: M200 (Volociximab)', 'Drug: Liposomal Doxorubicin']}, {'type': 'OTHER', 'label': 'Cohort 2', 'description': 'liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk', 'interventionNames': ['Drug: Liposomal Doxorubicin', 'Drug: M200 (Volociximab)']}, {'type': 'OTHER', 'label': 'Group A', 'description': 'liposomal doxorubicin, 40 mg/m2 q4wk', 'interventionNames': ['Drug: Liposomal Doxorubicin']}, {'type': 'OTHER', 'label': 'Group B', 'description': 'liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg q2wk (or other dose and schedule)', 'interventionNames': ['Drug: Liposomal Doxorubicin', 'Drug: M200 (Volociximab)']}, {'type': 'OTHER', 'label': 'Group C', 'description': 'liposomal doxorubicin, 40 mg/m2 q4wk, and volociximab 15 mg/kg qwk (or other dose and schedule)', 'interventionNames': ['Drug: Liposomal Doxorubicin', 'Drug: M200 (Volociximab)']}], 'interventions': [{'name': 'M200 (Volociximab)', 'type': 'DRUG', 'description': '7.5 mg/kg, IV infusion every week until disease progression', 'armGroupLabels': ['Cohort 1']}, {'name': 'Liposomal Doxorubicin', 'type': 'DRUG', 'description': '40 mg/m2, IV infustions every 4 weeks until disease progression, the maxium number of doses a subject can receive is 12.', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Group A', 'Group B', 'Group C']}, {'name': 'M200 (Volociximab)', 'type': 'DRUG', 'description': '15 mg/kg, IV infusions every week until disease progression', 'armGroupLabels': ['Cohort 2', 'Group C']}, {'name': 'M200 (Volociximab)', 'type': 'DRUG', 'description': '15 mg/kg, IV infustions every other week until disease progression', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75281', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90277', 'city': 'Redondo Beach', 'state': 'California', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75275', 'geoPoint': {'lat': 33.84918, 'lon': -118.38841}}, {'zip': '33323', 'city': 'Sunrise', 'state': 'Florida', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75296', 'geoPoint': {'lat': 26.13397, 'lon': -80.1131}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75299', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '31404', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75300', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60521', 'city': 'Hinsdale', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75301', 'geoPoint': {'lat': 41.80086, 'lon': -87.93701}}, {'zip': '21215', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75274', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '65109', 'city': 'Jackson', 'state': 'Missouri', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75294', 'geoPoint': {'lat': 37.38227, 'lon': -89.66621}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75279', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '78404', 'city': 'Corpus Christi', 'state': 'Texas', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75295', 'geoPoint': {'lat': 27.80058, 'lon': -97.39638}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75280', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '23185', 'city': 'Danville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75297', 'geoPoint': {'lat': 36.58597, 'lon': -79.39502}}, {'zip': '23185', 'city': 'Williamsburg', 'state': 'Virginia', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75298', 'geoPoint': {'lat': 37.2707, 'lon': -76.70746}}, {'zip': '54301', 'city': 'Green Bay', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 75278', 'geoPoint': {'lat': 44.51916, 'lon': -88.01983}}, {'zip': '5065', 'city': 'Toorak Gardens', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 75334', 'geoPoint': {'lat': -34.93478, 'lon': 138.63639}}, {'zip': '5011', 'city': 'Woodville South', 'country': 'Australia', 'facility': 'Site Reference ID/Investigator# 75335', 'geoPoint': {'lat': -34.88186, 'lon': 138.53477}}, {'zip': '2020', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'Site Reference ID/Investigator# 75337', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Site Reference ID/Investigator# 75336', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Site Reference ID/Investigator# 75338', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Site Reference ID/Investigator# 75415', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'Site Reference ID/Investigator# 75333', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '15-027', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'Site Reference ID/Investigator# 75344', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '31-531', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Site Reference ID/Investigator# 75339', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '20-090', 'city': 'Lublin', 'country': 'Poland', 'facility': 'Site Reference ID/Investigator# 75341', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '61-001', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Site Reference ID/Investigator# 75342', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '61-848', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Site Reference ID/Investigator# 75343', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '70-111', 'city': 'Szczecin', 'country': 'Poland', 'facility': 'Site Reference ID/Investigator# 75345', 'geoPoint': {'lat': 53.42894, 'lon': 14.55302}}, {'zip': '50-367', 'city': 'Wroclaw', 'country': 'Poland', 'facility': 'Site Reference ID/Investigator# 75340', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '129128', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Site Reference ID/Investigator# 75346', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '143423', 'city': 'Moscow', 'country': 'Russia', 'facility': 'Site Reference ID/Investigator# 75348', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'zip': '198255', 'city': 'Saint Petersburg', 'country': 'Russia', 'facility': 'Site Reference ID/Investigator# 75347', 'geoPoint': {'lat': 59.93863, 'lon': 30.31413}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Site Reference ID/Investigator# 75349', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Site Reference ID/Investigator# 75351', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08208', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Site Reference ID/Investigator# 75352', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '17007', 'city': 'Girona', 'country': 'Spain', 'facility': 'Site Reference ID/Investigator# 75350', 'geoPoint': {'lat': 41.98311, 'lon': 2.82493}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Site Reference ID/Investigator# 75353', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Site Reference ID/Investigator# 75354', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '901 85', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'Site Reference ID/Investigator# 75355', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}, {'zip': '6500', 'city': 'Bellinzona', 'country': 'Switzerland', 'facility': 'Site Reference ID/Investigator# 75416', 'geoPoint': {'lat': 46.19278, 'lon': 9.01703}}], 'overallOfficials': [{'name': 'Mihail Obrocea, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie (prior sponsor, Abbott)', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}