Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT01199718
Status:
UNKNOWN
Last Update Posted:
2011-06-15
First Post:
2010-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D010954', 'term': 'Plasmacytoma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C555142', 'term': 'silmitasertib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-13', 'studyFirstSubmitDate': '2010-09-09', 'studyFirstSubmitQcDate': '2010-09-09', 'lastUpdatePostDateStruct': {'date': '2011-06-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'One year (assessed at Cycle 1).', 'description': 'Adverse events classified as Dose limiting toxicities. Determination of maximum tolerated dose.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic and pharmacodynamic assessments.', 'timeFrame': 'One year - assessed throughout all cycles of participation', 'description': 'Blood levels of study drug when administered in escalating doses and modulation of biomarkers for CK2.'}, {'measure': 'Assess for efficacy response', 'timeFrame': 'One year (assessed after each cycle)', 'description': 'Response assessments including M-protein levels as detailed by the International Myeloma Working Group Uniform Response Criteria.'}, {'measure': 'Establish the recommended Phase 2 dose', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple myeloma', 'Plasmacytoma'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This Phase 1 study of oral CX-4945 is designed to test the safety, tolerability, and highest safe dose level of this CK2 inhibitor in patients with relapsed or refractory multiple myeloma.', 'detailedDescription': 'Elevated CK2 activity has been associated with malignant transformation and aggressive tumor growth. Over expression of CK2 has been documented in multiple types of cancers, including multiple myeloma, and inhibition of CK2 represents a potential therapeutic strategy to target a specific molecular defect perpetuating many cancers. CX-4945 has demonstrated potent inhibition of CK2 enzymatic activity. This study will evaluate the safety, pharmacokinetics, and pharmacodynamic effects of CX-4945 when administered to patients with multiple myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males or females at least 18 years of age\n* Confirmed relapsed or refractory multiple myeloma after at least two prior lines of therapy.\n* Measureable disease.\n* Karnofsky Performance Status at least 60%\n* Adequate liver and renal function and hematology laboratory values\n* Female patients of child-bearing potential must have a negative pregnancy test.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Treatment with systemic cancer therapy within 21 days before screening.\n* Major surgery within 4 weeks or minor surgery within 2 weeks of the start of study drug.\n* Grade 3 sensory neuropathy or motor neuropathy with pain\n* Concurrent severe or uncontrolled medical disease.\n* Active systemic fungal, bacterial, and/or viral infection.\n* Difficulty with swallowing, or an active malabsorption syndrome.\n* Gastrointestinal diseases including Crohn's disease or hemorrhagic coloproctitis.\n* History of gastric or small bowel surgery.\n* Pregnant or nursing females."}, 'identificationModule': {'nctId': 'NCT01199718', 'briefTitle': 'Study of CX-4945 in Patients With Relapsed or Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cylene Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of CX-4945 Administered Orally to Patients With Relapsed or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'C4-09-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CX-4945', 'description': 'CX-4945 oral formulation', 'interventionNames': ['Drug: CX-4945']}], 'interventions': [{'name': 'CX-4945', 'type': 'DRUG', 'description': 'CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.', 'armGroupLabels': ['CX-4945']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45249', 'city': 'Kettering', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle Owens, RN', 'role': 'CONTACT', 'email': 'michelle.owens@khnetwork.org'}], 'geoPoint': {'lat': 39.6895, 'lon': -84.16883}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Farnoush Abar, MD', 'role': 'CONTACT', 'email': 'abarfa@ohsu.edu'}], 'facility': 'Oregon Health Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97477', 'city': 'Springfield', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jeanne Schaffer, RN', 'role': 'CONTACT', 'email': 'jeanne.schaffer@usoncology.com'}], 'geoPoint': {'lat': 44.04624, 'lon': -123.02203}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jan Kueber, RN', 'role': 'CONTACT', 'email': 'jkueber@ghs.org'}], 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Gabrielle Geho, RN', 'role': 'CONTACT', 'email': 'Gabrielle.Geho@usoncology.com'}], 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '98902', 'city': 'Yakima', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jo Cook', 'role': 'CONTACT', 'email': 'jo.cook@yvmh.org'}], 'geoPoint': {'lat': 46.60207, 'lon': -120.5059}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cylene Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cylene Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Cylene Pharmaceuticals, Inc.'}}}}