Spots Global Cancer Trial Database for Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations
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Trial Identification
Brief Title: Study of Ulixertinib for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations
Official Title: A Two-Part, Phase II, Multi-center Study of the ERK Inhibitor Ulixertinib (BVD-523) for Patients With Advanced Malignancies Harboring MEK or Atypical BRAF Alterations
Study ID: NCT04488003
Study Description
Brief Summary: This BVD-523-ABC study builds on the safety and clinical activity experience of previous studies that have evaluated ulixertinib as a novel targeted cancer treatment in cohorts of patients with specific genetic alterations and tumor histologies that result in aberrant MAPK pathway signaling. Early clinical data have demonstrated anti-tumor activity with ulixertinib treatment and have identified specific groups of patients for whom additional development is warranted.
Detailed Description: This multi-center, phase II study will be conducted in two parts and assess the clinical benefit, safety, pharmacokinetics, and pharmacodynamics of ulixertinib (BVD-523) in patients with advanced malignancies. Part A (tumor histology agnostic) will be open label and enroll patients to one of six groups based on their tumor alteration. * Group 1: Patients with tumors, other than colorectal cancer (CRC), having a BRAF alteration that results in an amino acid change at positions G469, L485, or L597. * Group 2: Patients with tumors, other than CRC, having a defined Class 2 BRAF alteration (see Appendix 2 of protocol). * Group 3: Patients with tumors, other than CRC, having an atypical BRAF alteration (non V600) that is not specified in Group 1 or Group 2. * Group 4: Patients with CRC having any atypical BRAF alteration. * Group 5: Patients with tumors, other than CRC, harboring alterations in MEK1/2. * Group 6: Patients with CRC harboring alterations in MEK1/2. Part B (tumor histology specific) will randomly enroll patients with one of up to three specified tumor histologies to receive either ulixertinib or the physician's choice of treatment in a 2:1 ratio. Tumors must harbor a specified MEK or atypical BRAF alteration. If a patient progresses on physician's choice of treatment, crossover to the ulixertinib arm is permitted.The specific histologies to be included in this part will be selected based on available data and discussion with the clinical investigators, the medical monitor, and the sponsor.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic, Phoenix, Arizona, United States
Hoag Memorial Hospital Presbyterian, Newport Beach, California, United States
Christiana Care Health Services / Helen F. Graham Cancer Center, Newark, Delaware, United States
Johns Hopkins Sibley Memorial Hospital, Washington, District of Columbia, United States
University of Florida, Gainesville, Florida, United States
Mayo Clinic, Jacksonville, Florida, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Metro-Minnesota Community Oncology Research Consortium (MMCORC), Saint Louis Park, Minnesota, United States
Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States
Montefiore Medical Center, Bronx, New York, United States
Columbia University Irving Medical Center, New York, New York, United States
Duke University Medical Center / Duke Cancer Institute, Durham, North Carolina, United States
Kettering Cancer Center, Kettering, Ohio, United States
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Avera Cancer Institute, Sioux Falls, South Dakota, United States
Tennessee Oncology, PLLC - Sarah Cannon (SCRI), Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
University of Washington/Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Wisconsin Clinical Science Center, Madison, Wisconsin, United States
Marshfield Medical Center, Marshfield, Wisconsin, United States
Contact Details
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