Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT06987058
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RVU120 Rollover Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-05-15', 'studyFirstSubmitQcDate': '2025-05-15', 'lastUpdatePostDateStruct': {'date': '2025-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events (Safety and Tolerability)', 'timeFrame': '12 months', 'description': 'Number and grade of adverse events assessed by CTCAE v5.0'}], 'secondaryOutcomes': [{'measure': 'Duration of response', 'timeFrame': '12 months', 'description': 'Time from the first administration of RVU120-based treatment in the parent study until discontinuation of RVU120-based treatment for any reason in the rollover study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relapse', 'Refractory', 'Metastatic', 'Advanced', 'Solid Tumor', 'AML', 'Myelodysplastic syndrome'], 'conditions': ['Advanced Solid Tumors', 'Acute Myeloid Leukaemia (AML)', 'High-risk Myelodysplastic Syndrome']}, 'descriptionModule': {'briefSummary': 'This is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a RVU120 clinical study and to evaluate the safety of the treatment and record the time on treatment when continued under the same regimen as in the parent study.\n\nTo be eligible for this rollover study, participants must be continuing to benefit from their treatment, show an acceptable safety profile, and not have access to commercially available comparator anticancer therapy. Once transitioned to this study, participants will continue with their next planned dose per the regimen of their parent study.', 'detailedDescription': 'Participants may continue treatment until loss of clinical benefit as judged by the investigator, unacceptable toxicity, start of subsequent anticancer therapy, or until any other criterion for withdrawal from the treatment or the study is met.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The participant is enrolled in a RVU120 clinical study and receiving RVU120-based treatment given alone or in combination for at least 5 cycles.\n2. The participant is currently benefiting from, and expected to continue to benefit from, RVU120-based treatment according to the criteria set out in the parent study protocol and according to the judgment of the investigator and sponsor.\n3. The participant does not have access to commercially available comparator anticancer therapy.\n4. Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n5. The participant signed the rollover study ICF prior to any study-related procedure or study data collection.\n6. The participant agrees not to donate blood during study participation and until 28 weeks (\\~6.5 months) after the last dose.\n7. The investigator considers the participant to be eligible for participation in the rollover study.\n\nExclusion Criteria:\n\n1. Presence of toxicity that cannot be adequately managed.\n2. Concurrent participation in any therapeutic clinical study other than the parent study.'}, 'identificationModule': {'nctId': 'NCT06987058', 'acronym': 'ROVER-01', 'briefTitle': 'RVU120 Rollover Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ryvu Therapeutics SA'}, 'officialTitle': 'An Open-label Multicenter Rollover Study to Provide Continued Treatment to Participants Previously Enrolled in a RVU120 Clinical Study', 'orgStudyIdInfo': {'id': 'ROVER-01'}, 'secondaryIdInfos': [{'id': '2025-521673-14-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RVU120 single agent', 'description': 'Study intervention is assigned in accordance with the parent protocol and consists of RVU120-based treatment.', 'interventionNames': ['Drug: RVU120']}], 'interventions': [{'name': 'RVU120', 'type': 'DRUG', 'otherNames': ['SEL120'], 'description': 'RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19', 'armGroupLabels': ['RVU120 single agent']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80-214', 'city': 'Gdansk', 'country': 'Poland', 'contacts': [{'name': 'Rafał Dziadziuszko, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Uniwersyteckie Centrum Kliniczne', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'contacts': [{'name': 'Ana Alfonso Pierola, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}], 'centralContacts': [{'name': 'Head of Clinical Operations', 'role': 'CONTACT', 'email': 'clinicaltrials@ryvu.com', 'phone': '48538898766'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ryvu Therapeutics SA', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}