Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-28 @ 1:45 AM
Study NCT ID:
NCT01189903
Status:
UNKNOWN
Last Update Posted:
2014-01-28
First Post:
2010-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C559147', 'term': 'regorafenib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'lastUpdateSubmitDate': '2014-01-26', 'studyFirstSubmitDate': '2010-08-25', 'studyFirstSubmitQcDate': '2010-08-25', 'lastUpdatePostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Asian Colorectal Cancer Patients']}, 'referencesModule': {'references': [{'pmid': '10854137', 'type': 'BACKGROUND', 'citation': 'Goh BC, Fleming GF, Janisch L, Vogelzang NJ, Stadler WM, Ratain MJ. Development of a schedule-dependent population pharmacodynamic model for rhizoxin without quantitation of plasma concentrations. Cancer Chemother Pharmacol. 2000;45(6):489-94. doi: 10.1007/s002800051024.'}, {'pmid': '10430263', 'type': 'BACKGROUND', 'citation': 'Vokes EE, Goh BC, Bertucci D, Vogelzang NJ, Mani S, Ratain MJ. A Phase I study of raltitrexed and paclitaxel given every 3 weeks to patients with solid tumors. Cancer. 1999 Aug 1;86(3):528-32.'}]}, 'descriptionModule': {'briefSummary': '1. Primary Endpoints\n\n * Biomarker data suggestive of regorafenib-mediated inhibition of the RAS-RAF- MEK-ERK signal transduction pathway,of various tyrosine kinase receptors and/or of angiogenesis.\n * Evaluation of potential relationships between biomarker data and clinical activity.\n * Evaluation of a novel biomarker technology (Prometheus COPIA platform)\n2. Secondary Endpoints\n\n * Biomarker data suggestive of regorafenib-mediated effects on circulating rare cells.\n * Comparison of tumor genetic profiles obtained using DNA isolated from plasma, tumor biopsies and circulating tumor cells.\n * Patient safety data\n * Pharmacokinetics of regorafenib\n * Changes in tumor metabolic activity as measured by PET CT scan (optional)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically proven metastatic colorectal adenocarcinoma that is refractory to standard therapy and not amenable to surgery with curative intent.\n* Tumor characteristics:\n\n * At least one lesion that is suitable for a repeated biopsy; eg. subcutaneous nodule, skin lesion, rectal tumor, colonic mass easily reached by colonoscopy, peritoneal masses at least 3cm in maximum diameter that are easily assessable by image guided core biopsy.\n * For liver lesions, more superficially located lesions at least 3cm in maximum dimension with a rim of normal liver tissue, assessable safely by image guided core biopsy as determined by an experienced interventional radiologist.\n* Eastern Cooperative Oncology Group ECOG performance status of 0 or 1 (see Appendix 10.4).\n* Adequate bone marrow function (absolute neutrophil count =1,500/mm3; platelet count =100000/mm3; hemoglobin =9g/dl\n* Adequate liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:\n\n * Total bilirubin \\< 1.5 x the upper limit of normal (ULN).\n * Alanine transaminase (ALT) and aspartate aminotransferase (AST) \\< 2.5 x ULN (\\< 5 x ULN for patients with liver involvement of their cancer).\n * Amylase and lipase \\< 1.5 x the ULN\n * Serum creatinine \\< 1.5 x the ULN.\n * Glomerular filtration rate (GFR) = 30 ml/min/1.73 m2 according to the MDRD (Modified diet in renal disease) abbreviated formula\n* Prothrombin time, international normalized ratio (INR) and partial thromboplastin time less than or equal to 1.2 times the ULN.\n* Male or female at least 21 years of age.\n* A female subject is eligible to enter and participate in the study if she is:\n\n * Non-childbearing potential (ie. physiologically incapable of becoming pregnant) including any women who:\n * Has had a hysterectomy or\n * Has bilateral oophorectomy (ovariectomy) or\n * Has bilateral tubal ligation or\n * Is postmenopausal (demonstrate total cessation of menses for greater than or\n * Childbearing potential, has a negative serum or urine pregnancy test at screening, agrees to one of the following: double barrier contraception or abstinence.\n* Predicted life expectancy of at least 12 weeks.\n* Resting oxygen saturation greater than 92% on room air.\n* Written informed consent.\n* Able to swallow and retain oral medication.\n* Prothrombin time (PT), International Normalized Ratio for PT (PT INR), and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) within normal limits.\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01189903', 'briefTitle': 'Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'National University Hospital, Singapore'}, 'officialTitle': 'Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients', 'orgStudyIdInfo': {'id': 'CR01/18/10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Regorafenib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'state': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Boon Cher Goh, MBBS, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University Hospital, Singapore'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}}}}