Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-28 @ 3:10 AM
Study NCT ID:
NCT01339104
Status:
COMPLETED
Last Update Posted:
2014-10-01
First Post:
2011-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Label Regorafenib Study to Evaluate Cardiovascular Safety Parameters, Tolerability, and Anti-tumor Activity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C559147', 'term': 'regorafenib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-30', 'studyFirstSubmitDate': '2011-04-19', 'studyFirstSubmitQcDate': '2011-04-19', 'lastUpdatePostDateStruct': {'date': '2014-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of regorafenib on cardiovascular safety parameters measured by change in QT\\QTc on the ECG in patients with advanced solid tumors', 'timeFrame': 'After 8 weeks'}, {'measure': 'Effect on Left Ventricular Ejection Fraction (LVEF)', 'timeFrame': '12 weeks post Cycle 1'}], 'secondaryOutcomes': [{'measure': 'Decrease in tumor size based on investigator assessed RECIST criteria', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiovascular safety'], 'conditions': ['Neoplasms']}, 'referencesModule': {'references': [{'pmid': '26281907', 'type': 'DERIVED', 'citation': "Jones RL, Bendell JC, Smith DC, Diefenbach K, Lettieri J, Boix O, Lockhart AC, O'Bryant C, Moore KN. A phase I open-label trial evaluating the cardiovascular safety of regorafenib in patients with advanced cancer. Cancer Chemother Pharmacol. 2015 Oct;76(4):777-84. doi: 10.1007/s00280-015-2827-3. Epub 2015 Aug 18."}]}, 'descriptionModule': {'briefSummary': 'Open label Phase I study of Regorafenib to evaluate cardiovascular safety, tolerability and anti-tumor activity in patients with advanced solid tumors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects \\>/= 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1\n* Adequate bone marrow, liver, and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to dosing:\n\n * Hemoglobin (Hb) \\>/= 9.0 g/dL, Absolute neutrophil count (ANC) \\>/= 1500/mm³, Platelet \\>/= 100,000/mm³, Total bilirubin \\</= 1.5 times upper limit of normal (ULN), Alkaline phosphatase \\</= 4 x ULN\n * Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) \\</= 2.5 times ULN (\\</= 5.0 x ULN for subjects with liver involvement of their cancer), International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) \\< 1.5 x ULN, Serum creatinine \\</= 1.5 times ULN and glomerular filtration rate (GFR) \\>/= 30 ml/min/1.73 m² according to the MDRD (Modified Diet in Renal Disease) abbreviated formula, Lipase \\</= 1.5 x ULN\n * Left Ventricular Ejection Fraction (LVEF) \\>/= 50 % as assessed at the Baseline Multigated Acquisition (MUGA) scan\n * QTc (Q-T corrected) \\</= 470 msec at Screening\n* Having advanced, refractory disease\n* Life expectancy of at least 3 months\n* Recovery from any previous drug/procedure-related toxicity to Common Toxicological Criteria (CTC) Grade 0 or 1 levels (except alopecia), or to baseline preceding the prior treatment.\n\nExclusion Criteria:\n\n* History of cardiac disease: congestive heart failure \\> New York Heart Association (NYHA) Class II; active coronary artery disease (unstable angina \\[anginal symptoms at rest\\] or new-onset angina \\[began within the last 3 months\\] or myocardial infarction within the past 6 months).\n* Uncontrolled hypertension (failure of diastolic blood pressure to fall below 90 mmHg, despite the use of \\>/= 3 antihypertensive drugs or systolic blood pressure greater than 150 mmHg)\n* History of or known human immunodeficiency virus (HIV) infection or active hepatitis B or C.\n* Subjects with serious non-healing wound, ulcer, or bone fracture\n* Subjects with arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the 6 months before start of study medication\n* Persistent proteinuria of CTC Grade 3 or higher (\\> 3.5 g/24 hours, measured by urine protein/creatinine ratio on a random urine sample)\n* Symptomatic metastatic brain or meningeal tumors unless the subject is \\> 6 months from definitive therapy, has no evidence of tumor growth on an imaging study within 2 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry\n* Clinically significant bleeding (CTC AE Grade 3 or higher) within 30 days before start of study medication.\n* Subjects with seizure disorder requiring anticonvulsant medication\n* History of organ allograft'}, 'identificationModule': {'nctId': 'NCT01339104', 'briefTitle': 'Open Label Regorafenib Study to Evaluate Cardiovascular Safety Parameters, Tolerability, and Anti-tumor Activity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'An Open-label, Non-randomized Phase I Study of Regorafenib (BAY73-4506) to Evaluate Cardiovascular Safety Parameters, Tolerability, Pharmacokinetics, and Anti-tumor Activity in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': '14814'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Regorafenib', 'interventionNames': ['Drug: Regorafenib (Stivarga, BAY73-4506)']}], 'interventions': [{'name': 'Regorafenib (Stivarga, BAY73-4506)', 'type': 'DRUG', 'description': 'All subjects will receive regorafenib administered from Day 1 -21 at a dose of 160 mg od (4 x 40 mg tablets) followed by a 7 days break in repeating cycles of 28 days. The drug is to be taken in the morning with approximately 240 mL of water after having a low fat breakfast. Holter ECGs with triplicate measurements will automatically be obtained at specified timepoints over 24 hours on days -1 and Cycle 1, Day 21. PK samples will be drawn on Cycle 1, Day 21. PK timepoints are time-matched with Holter ECG timepoints. 24 hour urine will be collected beginning on Cycle 1, Day 21. MUGA scans will be done at screening, Cycle 2 Day 21 (after 42 doses of BAY73-4506), then every 3 cycles starting in Cycle 5, and at end of treatment.', 'armGroupLabels': ['Regorafenib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80010', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}