Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 11:20 PM
Study NCT ID:
NCT04566393
Status:
AVAILABLE
Last Update Posted:
2024-09-23
First Post:
2020-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Expanded Access to Ulixertinib (BVD-523) in Patients with Advanced MAPK Pathway-Altered Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D001749', 'term': 'Urinary Bladder Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System 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': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000618314', 'term': 'ulixertinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True}, 'nPtrsToThisExpAccNctId': 1}, 'statusModule': {'overallStatus': 'AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2020-09-17', 'studyFirstSubmitQcDate': '2020-09-21', 'lastUpdatePostDateStruct': {'date': '2024-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-28', 'type': 'ACTUAL'}}, 'conditionsModule': {'conditions': ['Pancreatic Cancer', 'Small Bowel Cancer', 'Colorectal Cancer', 'Melanoma', 'Non Small Cell Lung Cancer', 'Thyroid Cancer', 'Bladder Cancer', 'Head and Neck Cancer', 'Gastric Cancer', 'Esophageal Cancer', 'Cholangiocarcinoma', 'Ovarian Cancer', 'Hepatocellular Carcinoma', 'Glioblastoma', 'MAPK Gene Mutation', 'KRAS Activating Mutation', 'BRAF Gene Mutation', 'NRAS Gene Mutation', 'HRAS Gene Mutation', 'MEK Mutation', 'ERK Mutation']}, 'descriptionModule': {'briefSummary': 'The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who have incomplete response to or have exhausted available therapies.\n\nUlixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agent(s), conditionally approved by the drug manufacturer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Main Inclusion Criterion:\n\n 1\\. Patient has a MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations.\n* Other Inclusion Criteria:\n\n 1. In the opinion of the treating physician, the patient has exhausted or has inadequate response to available anti-cancer treatments.\n 2. In the opinion of the treating physician, the patient has adequate organ function to tolerate ulixertinib as defined in section 6.1\n 3. Male or female patients aged ≥ 12 years.\n 4. Patient must be able to swallow and retain orally administered medication.\n\n Note: Ulixertinib is primarily absorbed in the duodenum and therefore patients with any prior stomach or duodenal resection should be evaluated with that understanding.\n 5. For females, evidence of post-menopausal status or negative urinary or serum pregnancy test for pre-menopausal patients.\n 6. Highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration. In patients under the age of 18, who are not sexually active, abstinence is an acceptable form.\n 7. Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant\n 8. Ability to understand a written informed consent document, and the willingness to sign it. Assent will be obtained when appropriate based on the patient's age.\n\nExclusion Criteria:\n\n1. Patient is already participating in or qualifies for and is able to enroll in a clinical trial of ulixertinib (BVD-523).\n2. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting ulixertinib treatment, whichever is shorter.\n3. Patient has received radiotherapy within 14 days prior to the first dose of ulixertinib treatment other than for the allowable treatment of symptomatic bone metastasis.\n4. A history of current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)\n5. Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with ulixertinib due to safety concerns.\n6. Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with ulixertinib.\n7. Known hypersensitivity to ulixertinib or any component in its formulation.\n8. Patients taking prohibited medications as described in current Investigator's Brochure.\n\n Note: Patients who require treatment with Drugs that are strong inhibitors or inducers of CYP1A2, CYP2D6, and CYP3A4 (see Appendix 3) were excluded from the FIH study of ulixertinib and should be discussed with xCures to review if any potential benefits outweigh the potential risks.\n9. Patient is actively breastfeeding.\n10. Prior stomach or duodenal resection that in the opinion of the treating physician would affect the breakdown and absorption of ulixertinib."}, 'identificationModule': {'nctId': 'NCT04566393', 'briefTitle': 'Expanded Access to Ulixertinib (BVD-523) in Patients with Advanced MAPK Pathway-Altered Malignancies', 'organization': {'class': 'INDUSTRY', 'fullName': 'xCures'}, 'officialTitle': 'Expanded Access to Ulixertinib (BVD-523) in Patients with Advanced MAPK Pathway-Altered Malignancies', 'orgStudyIdInfo': {'id': 'ULI-EAP-100'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ulixertinib (BVD-523)', 'type': 'DRUG', 'description': 'Ulixertinib (BVD-523) is an oral, first-in-class ERK1/2 inhibitor'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Louis B Nabors, MD', 'role': 'CONTACT'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35805', 'city': 'Huntsville', 'state': 'Alabama', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Marshall Schreeder, MD', 'role': 'CONTACT'}], 'facility': 'Clearview Cancer Institute', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '36604', 'city': 'Mobile', 'state': 'Alabama', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Jose Galeas, MD', 'role': 'CONTACT'}], 'facility': 'Infirmary Cancer Care', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '93420', 'city': 'Arroyo Grande', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'David Palchak, MD', 'role': 'CONTACT'}], 'facility': 'PCR Oncology', 'geoPoint': {'lat': 35.11859, 'lon': -120.59073}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Michael Demeure, MD', 'role': 'CONTACT'}], 'facility': 'Hoag Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '94105', 'city': 'San Francisco', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'facility': 'xCures Inc.', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Naveed Wagle, MD', 'role': 'CONTACT'}], 'facility': "Providence Saint John's Health Center", 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Benjamin A Weinberg, MD', 'role': 'CONTACT'}], 'facility': 'MedStar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Jennifer E. Tseng, MD', 'role': 'CONTACT'}], 'facility': 'Orlando Health', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '52403', 'city': 'Cedar Rapids', 'state': 'Iowa', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Bharat Jenigiri, MD', 'role': 'CONTACT'}], 'facility': 'Unity Point Health - St. Lukes Hospital', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Joshua Lukenbill, DO', 'role': 'CONTACT'}], 'facility': 'Iowa Oncology Research Association', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '70809', 'city': 'Baton Rouge', 'state': 'Louisiana', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Jon Olson, MD', 'role': 'CONTACT'}], 'facility': 'Mary Bird Perkins Cancer Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '48314', 'city': 'Sterling Heights', 'state': 'Michigan', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Mohammad Mobayed, MD', 'role': 'CONTACT'}], 'facility': 'Oakland Macomb Cancer Specialists', 'geoPoint': {'lat': 42.58031, 'lon': -83.0302}}, {'zip': '68510', 'city': 'Lincoln', 'state': 'Nebraska', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Nathan B. Green, DO', 'role': 'CONTACT'}], 'facility': 'Cancer Partners of Nebraska', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '08822', 'city': 'Flemington', 'state': 'New Jersey', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Waqas Rehman, MD', 'role': 'CONTACT'}], 'facility': 'Hunterdon Hematology Oncology', 'geoPoint': {'lat': 40.51233, 'lon': -74.85933}}, {'zip': '07740', 'city': 'Long Branch', 'state': 'New Jersey', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Seth Cohen, MD', 'role': 'CONTACT'}], 'facility': 'Monmouth Medical Center', 'geoPoint': {'lat': 40.30428, 'lon': -73.99236}}, {'zip': '08056', 'city': 'Mickleton', 'state': 'New Jersey', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Carl J. Minniti Jr., MD', 'role': 'CONTACT'}], 'facility': 'The Minniti Center for Medical Oncology and Hematology', 'geoPoint': {'lat': 39.79011, 'lon': -75.23768}}, {'zip': '07901', 'city': 'Summit', 'state': 'New Jersey', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Bonni Guerin, MD', 'role': 'CONTACT'}], 'facility': 'Atlantic Health System/Overlook Medical Center', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}, {'zip': '11206', 'city': 'Brooklyn', 'state': 'New York', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Azriel Hirschfeld, MD', 'role': 'CONTACT'}], 'facility': 'Hirschfeld Oncology', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11794', 'city': 'Stony Brook', 'state': 'New York', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'MInsig Choi, MD', 'role': 'CONTACT'}], 'facility': 'Stony Brook Cancer Center', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Manish Bhandari, MD', 'role': 'CONTACT'}], 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '18103', 'city': 'Allentown', 'state': 'Pennsylvania', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Suresh Nair, MD', 'role': 'CONTACT'}], 'facility': 'Lehigh Valley Health Network', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'status': 'AVAILABLE', 'country': 'United States', 'contacts': [{'name': 'Frank Senecal, MD', 'role': 'CONTACT'}], 'facility': 'Northwest Medical Specialties', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'centralContacts': [{'name': 'xCures Clinical Operations', 'role': 'CONTACT', 'email': 'expandedaccess@xcures.com', 'phone': '(707) 641-4475'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'xCures', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Cancer Commons', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}