Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00955292
Status:
TERMINATED
Last Update Posted:
2009-08-10
First Post:
2009-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose-escalation Study of Quarfloxin in Patients With Advanced Solid Tumors or Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C545184', 'term': 'CX 3543'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Modified dose schedule presented no advantage over previously studied schedule', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-07', 'studyFirstSubmitDate': '2009-08-07', 'studyFirstSubmitQcDate': '2009-08-07', 'lastUpdatePostDateStruct': {'date': '2009-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum tolerated dose (MTD) and Dose limiting toxicity (DLT)', 'timeFrame': 'Cycle 1'}, {'measure': 'Recommended Phase 2 dose', 'timeFrame': 'Cycle 1'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) in humans of intravenously administered quarfloxin', 'timeFrame': 'One month'}, {'measure': 'Evaluation of antitumor activity of quarfloxin by objective radiologic assessment', 'timeFrame': 'Every 2 months'}, {'measure': 'Pharmacodynamic evaluation of antitumor activity', 'timeFrame': 'Monthly'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Solid Tumors', 'Lymphoma', 'G-Quadruplex'], 'conditions': ['Advanced Solid Tumors', 'Lymphoma']}, 'descriptionModule': {'briefSummary': 'This phase 1 study of quarfloxin (CX-3543) is designed to test the safety, tolerability, and highest safe dose of this drug when administered intravenously weekly for three weeks of a four week cycle in patients with advanced solid tumors.', 'detailedDescription': 'Quarfloxin is a first-in-class small-molecule targeted cancer therapeutic derived from the validated fluoroquinolone class of drugs. Quarfloxin was rationally designed to target a G-quadruplex (QPLX) DNA structure and disrupt protein-DNA interactions essential to cancer cells. The QPLX targeted by quarfloxin forms within ribosomal DNA (rDNA) and the QPLX is bound by the nucleolin protein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with histologically confirmed solid tumors or lymphomas.\n* Tumor progression after receiving standard/approved chemotherapy or where there is no approved therapy.\n* One or more tumors measurable on radiograph or CT scan, or evaluable disease (e.g., malignant ascites).\n* Karnofsky performance status of greater than or equal to 70.\n* Life expectancy of at least 3 months.\n* Age at least 18 years.\n* Patients must have central IV access, or agree to the insertion of a central IV line.\n* Normal oxygen saturation by pulse oximetry on room air\n* A negative pregnancy test (if female).\n* Acceptable liver function as evaluated by laboratory results\n* Acceptable renal function as evaluated by laboratory results\n* Acceptable hematologic status as evaluated by laboratory results\n* No clinically significant urinalysis abnormalities\n* Acceptable coagulation status as evaluated by laboratory results\n* Fertile men and women must use effective contraceptive methods during the study.\n\nExclusion Criteria:\n\n* Seizure disorders requiring anticonvulsant therapy.\n* Known brain metastases (unless previously treated and well controlled for a period of greater than or equal to 3 months).\n* Severe chronic obstructive pulmonary disease with hypoxemia, or an uncorrectable pulmonary compromise.\n* Major surgery, other than diagnostic surgery, within 4 weeks prior to the first dose of test drug.\n* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.\n* Pregnant or nursing women.\n* Treatment with radiation therapy, surgery, chemotherapy, or investigational therapy within one month prior to study entry (6 weeks for nitrosoureas or Mitomycin C).\n* Unwillingness or inability to comply with procedures required in this protocol.\n* Known infection with HIV, hepatitis B, or hepatitis C.\n* Clinically significant bleeding event within the last 3 months, unrelated to trauma, or underlying condition that would be expected to result in a bleeding diathesis.\n* Patients who are currently receiving any other investigational agent.\n* Patients who have exhibited allergic reactions to a similar structural compound (e.g., fluoroquinolones, biological agent or formulation.'}, 'identificationModule': {'nctId': 'NCT00955292', 'briefTitle': 'Dose-escalation Study of Quarfloxin in Patients With Advanced Solid Tumors or Lymphomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cylene Pharmaceuticals'}, 'officialTitle': 'A Phase I, Multicenter, Open-label, Dose-Escalation, Safety, Pharmacokinetic and Pharmacodynamic Study of Quarfloxin Administered Intravenously Weekly for Three Weeks of a Four Week Cycle in Patients With Advanced Solid Tumors or Lymphomas', 'orgStudyIdInfo': {'id': 'C3-07-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Quarfloxin', 'interventionNames': ['Drug: Quarfloxin']}], 'interventions': [{'name': 'Quarfloxin', 'type': 'DRUG', 'otherNames': ['CX-3543', 'Quarfloxacin'], 'description': 'Escalating doses of quarfloxin administered intravenously for 24 hours once weekly for three weeks every four weeks', 'armGroupLabels': ['Quarfloxin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cylene Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'C. Padgett', 'oldOrganization': 'Cylene Pharmaceuticals'}}}}