Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-26 @ 8:34 PM
Study NCT ID:
NCT03804866
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2018-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NGR-hTNF in Combination With an Anthracycline in Platinum-resistant Ovarian Cancer (NGR018)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C464839', 'term': 'tumor necrosis factor-alpha, CNGRC fusion protein, human'}, {'id': 'C506643', 'term': 'liposomal doxorubicin'}, {'id': 'D004317', 'term': 'Doxorubicin'}], 'ancestors': [{'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-14', 'studyFirstSubmitDate': '2018-10-03', 'studyFirstSubmitQcDate': '2019-01-14', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety according to NCI-CTCAE criteria (version 4.03)', 'timeFrame': 'from the start of treatment until 28 days after last treatment', 'description': 'To evaluate safety profile related to NGR-hTNF'}], 'secondaryOutcomes': [{'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'from randomization date, every 6-8 weeks based on chemotherapy during treatment and every 12 weeks during follow-up until first documented PD or death from any cause, whichever came first, assessed up through study completion, approximately 12 months', 'description': 'Defined as the time from the date of randomization until disease progression, or death'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'from randomization date, every 6-8 weeks based on type of chemotherapy during treatment and every 12 weeks during follow-up until date of death, from any cause, assessed up through study completion, approximately 12 months', 'description': 'defined as the time from the date of randomization until death due to any cause'}, {'measure': 'Response Rate (RR)', 'timeFrame': 'from randomization date, every 6-8 weeks based on chemotherapy during treatment and every 12 weeks during follow-up until first documented PD or death from any cause, whichever came first, assessed up through study completion, approximately 12 months', 'description': 'defined as the percentage of patients who have a best-response rating of complete or partial response, according to standard RECIST criteria'}, {'measure': 'Disease Control Rate (DCR)', 'timeFrame': 'from randomization date, every 6-8 weeks based on chemotherapy during treatment and every 12 weeks during follow-up until first documented PD or death from any cause, whichever came first, assessed up through study completion, approximately 12 months', 'description': 'defined as the percentage of patients who have a best-response rating of complete response, partial response, or stable disease, according to standard RECIST criteria'}, {'measure': 'Duration of Disease Control', 'timeFrame': 'from randomization date, every 6-8 weeks based on chemotherapy during treatment and every 12 weeks during follow-up until first documented PD or death from any cause, whichever came first, assessed up through study completion, approximately 12 months', 'description': 'measured from the date of randomization until disease progression, or death due to any cause'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NGR-hTNF', 'Pegylated liposomal doxorubicin', 'Doxorubicin', 'Platinum-resistant', 'Progression or recurrence Ovarian Cancer', 'Ovarian Cancer', 'Advanced or metastatic'], 'conditions': ['Ovarian Cancer']}, 'descriptionModule': {'briefSummary': 'The primary objective of this extension protocol is to evaluate the early safety of a new schedule of NGR-hTNF given weekly, instead of every 3 or 4 weeks, in a cohort of 12 patients randomized to the experimental arm A, as compared to a reference cohort of 12 patients randomized to an anthracycline alone', 'detailedDescription': 'In this extension protocol IPR/26 of completed IPR/24 study, considering the relatively short half-life of approximately 1 hour and the favourable toxicity profile of NGR-hTNF, characterized by transient constitutional symptoms occurring during the first day of administration, an additional cohort of 24 patients will be randomized and the 12 patients enrolled in arm A will receive the same dose of NGR-hTNF 0.8 mcg/m2 given as 60 minutes infusion every week. the weekly schedule of NGR-hTNF 0.8 mcg/m2 has previously been tested in several studies'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically-proven ovarian cancer, fallopian tube and primary peritoneal cancer in advanced or metastatic stage\n* Patients previously treated with a maximum of two platinum-based regimen plus paclitaxel and with documented progressive disease on treatment (refractory patient population) or within 6 months from last chemotherapy cycle (resistant patient population)\n* ECOG Performance status 0 - 2\n* Life expectancy of 12 weeks or more\n* Normal cardiac function and absence of uncontrolled hypertension\n* Adequate baseline bone marrow, hepatic and renal function defined as follows:\n\n 1. Neutrophils ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L; hemoglobin ≥ 9 g/dL\n 2. Bilirubin ≤ 1.5 x ULN\n 3. AST and/or ALT ≤ 2.5 x ULN in absence of liver metastasis or ≤ 5 x ULN in presence of liver metastasis\n 4. Serum creatinine \\< 1.5 x ULN\n* At least one (not previously irradiated) target lesion or non-measurable disease only, according to RECIST criteria\n* Patients may have had prior therapy providing the following conditions are met:\n\n 1. Surgery and radiation therapy: wash-out period of 14 days\n 2. Systemic anti-tumor therapy: wash-out period of 21 days\n* Patients must give written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Patients must not receive any other investigational agents while on study\n* More than two previous chemotherapy lines and previous treatment with anthracycline\n* Patients with myocardial infarction within the last six months, unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication\n* Prolonged QTc interval (congenital or acquired) \\> 450 ms\n* History or evidence upon physical examination of CNS disease unless adequately treated\n* Patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol\n* Known hypersensitivity/allergic reaction or contraindications to human albumin preparations or to any of the excipients\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT03804866', 'briefTitle': 'NGR-hTNF in Combination With an Anthracycline in Platinum-resistant Ovarian Cancer (NGR018)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AGC Biologics S.p.A.'}, 'officialTitle': 'NGR018: Randomized Phase II Study of NGR-hTNF Plus an Anthracycline Versus an Anthracycline Alone in Platinum-resistant Ovarian Cancer', 'orgStudyIdInfo': {'id': 'NGR018-IPR/26'}, 'secondaryIdInfos': [{'id': '2012-005745-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: NGR-hTNF+ anthracycline', 'description': 'NGR-hTNF+Pegylated Liposomal Doxorubicin or Doxorubicin', 'interventionNames': ['Drug: NGR-hTNF', 'Drug: Pegylated liposomal doxorubicin', 'Drug: Doxorubicin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: anthracycline', 'description': 'Pegylated Liposomal Doxorubicin or Doxorubicin', 'interventionNames': ['Drug: Pegylated liposomal doxorubicin', 'Drug: Doxorubicin']}], 'interventions': [{'name': 'NGR-hTNF', 'type': 'DRUG', 'description': 'NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs', 'armGroupLabels': ['Arm A: NGR-hTNF+ anthracycline']}, {'name': 'Pegylated liposomal doxorubicin', 'type': 'DRUG', 'description': '50 mg/m² iv every 4 weeks until confirmed evidence of disease progression', 'armGroupLabels': ['Arm A: NGR-hTNF+ anthracycline', 'Arm B: anthracycline']}, {'name': 'Doxorubicin', 'type': 'DRUG', 'description': '60 mg/m² iv every 3 weeks for a maximum of 8 cycles', 'armGroupLabels': ['Arm A: NGR-hTNF+ anthracycline', 'Arm B: anthracycline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione IRCCS Istituto Nazionale dei Tumori', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '20141', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Europeo di Oncologia', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '80131', 'city': 'Naples', 'country': 'Italy', 'facility': 'Istituto Nazionale Tumori IRCCS Fondazione "Giovanni Pascale"', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}], 'overallOfficials': [{'name': 'Antonio Lambiase, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AGC Biologics S.p.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AGC Biologics S.p.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}