Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2026-01-07 @ 3:02 AM
Study NCT ID:
NCT02796261
Status:
UNKNOWN
Last Update Posted:
2022-01-21
First Post:
2016-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000518', 'term': 'Eflornithine'}, {'id': 'D008130', 'term': 'Lomustine'}], 'ancestors': [{'id': 'D009952', 'term': 'Ornithine'}, {'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D009607', 'term': 'Nitrosourea Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009603', 'term': 'Nitroso Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 343}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'dispFirstSubmitDate': '2025-06-05', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-19', 'studyFirstSubmitDate': '2016-06-03', 'studyFirstSubmitQcDate': '2016-06-07', 'lastUpdatePostDateStruct': {'date': '2022-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical benefit response (CBR) based on magnetic resonance imaging (MRI) criteria', 'timeFrame': '4 years'}, {'measure': 'OS rate at 18 months (OS-18)', 'timeFrame': '18 months'}, {'measure': 'Relevance of OS, PFS, ORR, and CBR to commonly used molecular/genetic biomarkers obtained from most recent pre-study tumor samples', 'timeFrame': '4 years'}, {'measure': 'Pharmacokinetic Analysis - Maximum concentrations (Cmax) of eflornithine in plasma will be determined.', 'timeFrame': '1 Month'}, {'measure': 'PK - Area under the curve (AUC) of eflornithine in plasma will be determined.', 'timeFrame': '1 Month'}], 'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival (PFS)', 'timeFrame': '4 years'}, {'measure': 'Objective response rate (ORR)', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Anaplastic Astrocytoma', 'Grade 3 Glioma', 'Glioma', 'Eflornithine', 'Brain Cancer', 'Brain Tumor', 'Neuro-oncology', 'Progressive Anaplastic Astrocytoma', 'Recurrent Anaplastic Astrocytoma', 'Progressive Glioma', 'Recurrent Glioma', 'Malignant Glioma', 'Progressive Brain Tumor', 'Recurrent Brain Tumor'], 'conditions': ['Anaplastic Astrocytoma', 'Recurrent Anaplastic Astrocytoma']}, 'referencesModule': {'references': [{'pmid': '41325560', 'type': 'DERIVED', 'citation': 'Colman H, Lombardi G, Wong ET, Walbert T, Eoli M, Lassman AB, Peereboom DM, Kizilbash SH, Kamiya-Matsuoka C, Pitz MW, Strowd RE, Desjardins A, Kumthekar P, Mason W, Pellerino A, Soffietti R, Butowski N, Forsyth PA, Hamza MA, Hau P, Lallana E, Nabors B, Piccioni D, Uhlmann EJ, Welsh LC, Wen PY, Dietrich J, Wang C, Levin VA. STELLAR: Phase III, Randomized, Open-Label Study of Eflornithine Plus Lomustine Versus Lomustine Alone in Patients With Recurrent Grade 3 Astrocytoma. J Clin Oncol. 2025 Dec 1:JCO2501204. doi: 10.1200/JCO-25-01204. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy and safety of eflornithine in combination with lomustine, compared to lomustine taken alone, in treating patients whose anaplastic astrocytoma has recurred/progressed after radiation and temozolomide chemotherapy.', 'detailedDescription': 'This study will consist of 4 study periods of up to 50 months in total, consisting of:\n\nScreening Period - A maximum screening duration of 4 weeks.\n\nTreatment Period - Treatment Arm A up to 24 months; Treatment Arm B up to 12 months.\n\nEnd of Treatment Visit - A minimum of 4 weeks post last treatment for both arms.\n\nFollow-Up Period - Up to approximately 36 months, or until patient death.\n\nA total of approximately 340 patients will be randomized in a 1:1 ratio to receive either eflornithine + lomustine or lomustine alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients must meet all of the following inclusion criteria to be eligible for participation in this study:\n\n* Surgical or biopsy-proven diagnosis of WHO grade 3 AA.\n* First AA tumor progression or recurrence ≤ 6 months prior to randomization based on MRI using T2 hyperintesity, gadolinium (Gd)-contrast enhancement, or both. To avoid enrollment of patients with glioblastoma, patients with Gd-contrast enhancing tumors will be eligible if there is no necrosis seen on MRI and any of the following criteria is true:\n\n 1. Gd-contrast lesion margins are not clearly defined,\n 2. Gd-contrast lesions are only measurable in one dimension,\n 3. Gd-contrast lesion has two perpendicular diameters less than 10 mm,\n 4. Gd-contrast lesion has two perpendicular diameters greater than 10 mm but less than 20 mm and lesion does not demonstrate central necrosis,\n 5. Recent histopathological confirmation of WHO grade 3 AA\n* Received EBRT and temozolomide chemotherapy prior to first tumor progression or recurrence of WHO Grade 3 AA.\n* Completion of EBRT ≥ 6 months prior to randomization.\n* A patient whose AA tumor has progressed or recurred and has had another surgical resection prior to randomization will be eligible if a) pathology review confirms AA, and b) post-surgical MRI demonstrates measurable tumor on T2 FLAIR.\n* Karnofsky Performance Status (KPS) score of ≥ 70.\n\nExclusion Criteria:\n\nPatients who meet any of the following exclusion criteria are not eligible for study participation:\n\n* MRI defining progression is consistent with a diagnosis of glioblastoma or radiation necrosis.\n* Patients who are considered to be refractory to EBRT and temozolomide but who have not progressed.\n* Prior systemic therapy for recurrence of AA.\n* Presence of extracranial or leptomeningeal disease.\n* Prior lomustine use.\n* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study.\n* Pregnant or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT02796261', 'acronym': 'STELLAR', 'briefTitle': 'Study to Evaluate Eflornithine + Lomustine vs Lomustine in Recurrent Anaplastic Astrocytoma (AA) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Orbus Therapeutics, Inc.'}, 'officialTitle': 'A Randomized Phase 3 Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine With Lomustine Compared to Lomustine Alone in Patients With AA That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy', 'orgStudyIdInfo': {'id': 'OT-15-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eflornithine + Lomustine', 'description': 'Eflornithine dosed on a 2 weeks on, 1 week off schedule + Lomustine dosed every 6 weeks', 'interventionNames': ['Drug: Eflornithine', 'Drug: Lomustine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lomustine', 'description': 'Lomustine dosed every 6 weeks', 'interventionNames': ['Drug: Lomustine']}], 'interventions': [{'name': 'Eflornithine', 'type': 'DRUG', 'otherNames': ['DFMO'], 'description': 'Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule', 'armGroupLabels': ['Eflornithine + Lomustine']}, {'name': 'Lomustine', 'type': 'DRUG', 'otherNames': ['CCNU', 'CeeNU', 'Gleostine'], 'description': 'Lomustine 90 mg/m2 administered orally once every 6 weeks', 'armGroupLabels': ['Eflornithine + Lomustine']}, {'name': 'Lomustine', 'type': 'DRUG', 'otherNames': ['CCNU', 'CeeNU', 'Gleostine'], 'description': 'Lomustine 110 mg/m2 administered orally once every 6 weeks', 'armGroupLabels': ['Lomustine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35401', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': 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'95825', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Moores Cancer Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco Medical Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'John Wayne Cancer Institute', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 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Jacobs Health Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'OhioHealth Research and Innovation Institute', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence Brain & Spine Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina, Hollings Cancer Center', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Oncology Austin Brain Tumor Center', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Neuro-Oncology Associates', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Health Services', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '3000', 'city': 'Leuven', 'state': 'Flemish Brabant', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '5530', 'city': 'Yvoir', 'state': 'Namur', 'country': 'Belgium', 'facility': 'Cliniques Universitaires UCL De Mont-Godinne', 'geoPoint': {'lat': 50.3279, 'lon': 4.88059}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Center', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Research Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H3A 2B4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Neurological Institute and Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': '49055', 'city': 'Angers', 'country': 'France', 'facility': "Institut de Cancerologie de l'Ouest - 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Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6JJ', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Royal Marsden NHS Foundation Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'The Christie NHS Foundation Trust', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orbus Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}