Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-28 @ 10:35 PM
Study NCT ID:
NCT01466504
Status:
TERMINATED
Last Update Posted:
2013-04-15
First Post:
2011-10-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'C565799', 'term': 'Ectrodactyly, Ectodermal Dysplasia, and Cleft Lip-Palate Syndrome 3'}, {'id': 'D005076', 'term': 'Exanthema'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'skin biopsies will be performed using a 4mm biopsy punch. Participants will undero 2 skin biopsies - one prior to starting sorafenib or regorafenib, the other once rash develops. If a rash does not develop within 84 days a biopsy of normal skin will be done.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Accrual did not meet expectations. Over nearly 2 years just 4 subjects were treated on study. The goal of 30 subjects was not attainable.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-04-11', 'studyFirstSubmitDate': '2011-10-31', 'studyFirstSubmitQcDate': '2011-11-07', 'lastUpdatePostDateStruct': {'date': '2013-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'p63 expression levels', 'timeFrame': 'Week 12', 'description': 'Tissue collection is done within 7 days prior to treatment and when rash develops. If no rash develops, normal skin will be biopsied at week twelve of treatment.'}], 'secondaryOutcomes': [{'measure': 'Tumor response', 'timeFrame': 'Week 12', 'description': 'Sorafenib and regorafenib potentially interfere with p63 expression and keratinocyte differentiation and skin remodeling. The extent of interference may indicate extent of tumor response.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['P63', 'Sorafenib', 'Regorafenib', 'rash', 'skin toxicity', 'RCC', 'HCC', 'colorectal carcinoma'], 'conditions': ['Renal Cell Carcinoma', 'Hepatocellular Carcinoma', 'Colorectal Carcinoma']}, 'descriptionModule': {'briefSummary': 'Skin toxicity is a frequently observed side effect in the era of "molecularly targeted therapies". Skin toxicity following administration of protein kinase inhibitors such as sorafenib, regorafenib, lapatinib, sunitinib, and others can be debilitating to the patient, resulting in dose reduction and discontinuation of treatment. The mechanisms of skin toxicity induced by targeted chemotherapy, such as sorafenib or regorafenib, are poorly understood. Further research is warranted to better understand the pathophysiology of drug-related skin toxicity in this setting and develop correction strategies. This study tests the hypothesis that sorafenib and regorafenib interfere with p63 expression and keratinocyte differentiation and skin remodeling.\n\nEligible study participants will be evaluated clinically for evidence of skin toxicity during their visits to the outpatient Oncology clinics. Study participants will undergo skin biopsies before sorafenib or regorafenib treatment is initiated and once rash develops or 12 weeks into treatment with sorafenib or regorafenib. Skin biopsies will be performed in Oncology clinics by the study investigators and clinic support staff.\n\nStudy participants will undergo both skin biopsies regardless of whether they develop a rash. In patients who develop a rash the most representative lesion will be biopsied. A normal appearing area of skin will be biopsied in participants who do not develop a rash.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cancer diagnosis of Renal Cell Carcinoma (RCC) or Hepatocellular Carcinoma (HCC) or Colorectal Carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, 18 years old or older.\n2. Histologically or cytologically confirmed diagnosis of a solid tumor (RCC, HCC, or colorectal cancer).\n3. Participants are planning to initiate treatment with either sorafenib or regorafenib as a single chemotherapeutic agent\n4. Able to swallow and retain oral medication and does not have any clinically relevant, active gastrointestinal disease or other condition that may significantly alter absorption, distribution, metabolism, or excretion of drugs.\n5. Be able to provide written informed consent.\n\nExclusion Criteria\n\n1. Patients who are or will be receiving other chemotherapeutic or molecularly targeted agents in addition to sorafenib or regorafenib\n2. Concurrent moderate or severe chronic inflammatory skin condition (eczema, psoriasis)\n3. Concurrent blistering skin disorder of any severity (such as pemphigus, bullous pemphigoid)\n4. Connective tissue disorders with skin involvement (systemic lupus erythematosus, scleroderma, dermatomyositis, etc.)\n5. Patients manifesting an allergic skin reaction (such as urticaria) or skin reaction as a complication of prior chemotherapy\n6. Patients with skin lesions of infectious or non-infectious cause, precluding skin biopsy\n7. Patients not willing to undergo skin biopsy\n8. Patients who are pregnant or planning to become pregnant during their participation in the study.\n9. Chemotherapy, targeted therapy, or biological therapy within two weeks of start of treatment.\n10. Ability to give informed consent is compromised by cognitive and/or decisional impairment.'}, 'identificationModule': {'nctId': 'NCT01466504', 'briefTitle': 'Effect of Sorafenib or Regorafenib on P63 Expression and Keratinocyte Differentiation in Human Skin', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'A Study of the Effect of Sorafenib or Regorafenib on p63 Expression and Keratinocyte Differentiation in Human Skin', 'orgStudyIdInfo': {'id': 'D11004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'skin punch biopsy', 'type': 'PROCEDURE', 'description': 'Skin biopsy prior to sorafenib or regorafenib treatment and when rash appears or 12 weeks into treatment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center, Norris Cotton Cancer Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}, {'zip': '05009', 'city': 'White River Junction', 'state': 'Vermont', 'country': 'United States', 'facility': 'White River Junction VA Medical Center', 'geoPoint': {'lat': 43.64896, 'lon': -72.31926}}], 'overallOfficials': [{'name': 'Alexey V Danilov, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}