Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-27 @ 9:57 PM
Study NCT ID:
NCT05161195
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-21
First Post:
2021-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Roll-over Study to Allow Continued Access to Ribociclib
Sponsor:
Organization:
Raw JSON
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'Heterocyclic Compounds'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004958', 'term': 'Estradiol'}, {'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D045166', 'term': 'Estradiol Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'nctId': 'NCT05038631', 'statusForNctId': 'AVAILABLE', 'hasExpandedAccess': True}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2030-08-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-17', 'studyFirstSubmitDate': '2021-12-03', 'studyFirstSubmitQcDate': '2021-12-03', 'lastUpdatePostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with treatment-emergent adverse events (AES)', 'timeFrame': 'From day of first dose of study medication to 30 days after last dose of study medication, up to 5 years', 'description': 'The percentage of participants with treatment-emergent adverse events will be summarized, including significant adverse events leading to discontinuation, and adverse events leading to dose adjustment'}], 'secondaryOutcomes': [{'measure': 'Clinical benefit rate', 'timeFrame': 'Up to 5 years', 'description': 'Percentage of participants with clinical benefit as assessed by the Investigator at scheduled study visits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Roll-over Protocol', 'Ribociclib', 'HR-positive', 'HER2-negative', 'Breast Cancer', 'Ribociclib in combination with other drugs', 'LEE011'], 'conditions': ['Metastatic Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is an open-label, multi-center, roll-over study to evaluate the long term safety of ribociclib in combination with other drugs in participants who are participating in a Novartis sponsored global study, that has fulfilled requirements for its primary objective(s), and who in the opinion of the Investigator, would benefit from continued treatment.', 'detailedDescription': 'The purpose of this study is to evaluate long-term safety and provide continued treatment to participants who are currently receiving ribociclib in combination with other drugs in a parent study, that has fulfilled requirements for its primary objective(s), and in the opinion of the Investigator, would benefit from continuing treatment at time of discontinuation from the parent study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key inclusion Criteria:\n\n1. Currently participating in a Novartis sponsored global study (parent study), receiving treatment with ribociclib in combination with other drugs, and the parent study has fulfilled its primary objective(s)\n2. Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study\n3. Currently has evidence of clinical benefit as determined by the Investigator\n\nKey exclusion Criteria:\n\n1. Permanent discontinuation of ribociclib in the parent study\n2. Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study 3. Local access to commercially available ribociclib and reimbursed\n\nOther protocol-defined inclusion/exclusion criteria may apply at the end'}, 'identificationModule': {'nctId': 'NCT05161195', 'briefTitle': 'Roll-over Study to Allow Continued Access to Ribociclib', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study', 'orgStudyIdInfo': {'id': 'CLEE011A2412B'}, 'secondaryIdInfos': [{'id': '2024-514891-41-00', 'type': 'REGISTRY', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Ribociclib', 'description': 'All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study.', 'interventionNames': ['Drug: Ribociclib', 'Drug: Letrozole', 'Drug: Anastrozole', 'Drug: Goserelin', 'Drug: Tamoxifen', 'Drug: Fulvestrant']}], 'interventions': [{'name': 'Ribociclib', 'type': 'DRUG', 'description': 'Participants continue ribociclib as was administered in their parent study', 'armGroupLabels': ['Ribociclib']}, {'name': 'Letrozole', 'type': 'DRUG', 'description': 'Participants continue ribociclib in combination with letrozole as was administered in their parent study', 'armGroupLabels': ['Ribociclib']}, {'name': 'Anastrozole', 'type': 'DRUG', 'description': 'Participants continue ribociclib in combination with anastrozole as was administered in their parent study', 'armGroupLabels': ['Ribociclib']}, {'name': 'Goserelin', 'type': 'DRUG', 'description': 'Participants continue ribociclib in combination with goserelin as was administered in their parent study', 'armGroupLabels': ['Ribociclib']}, {'name': 'Tamoxifen', 'type': 'DRUG', 'description': 'Participants continue ribociclib in combination with tamoxifen as was administered in their parent study', 'armGroupLabels': ['Ribociclib']}, {'name': 'Fulvestrant', 'type': 'DRUG', 'description': 'All participants continue ribociclib in combination with fulvestrant as was administered in their parent study', 'armGroupLabels': ['Ribociclib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Ironwood Cancer and Research Centers', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Beverly Hills Cancer Center', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Poudre Valley Hospital', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '32763', 'city': 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