Spots Global Cancer Trial Database for A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study to Assess Naporafenib (ERAS-254) Administered With Trametinib in Patients With RAS Q61X Mutations
Official Title: An Open-label Study to Assess the Safety and Efficacy of Naporafenib (ERAS-254) Administered With Trametinib in Previously Treated Patients With Locally Advanced Unresectable or Metastatic Solid Tumor Malignancies With RAS Q61X Mutations
Study ID: NCT05907304
Conditions
Study Description
Brief Summary: To evaluate the efficacy of naporafenib administered with trametinib in patients with rat sarcoma viral oncogene (RAS) Q61X solid tumors * To evaluate the safety and tolerability of naporafenib administered with trametinib in patients with RAS Q61X solid tumors * To characterize the pharmacokinetic (PK) profile of naporafenib and trametinib when administered to patients with RAS Q61X solid tumors
Detailed Description: SEACRAFT-1 is an open-label study to assess the safety and efficacy of naporafenib administered with trametinib in previously treated patients with locally advanced unresectable or metastatic RAS Q61X solid tumor malignancies. The study will enroll a total of approximately 100 adult patients; a sub-study will enroll approximately 15 adolescent patients ≥12 and \<18 years for a total sample size of approximately 115. Patients with a locally advanced unresectable or metastatic solid tumor malignancy that is not responsive to standard therapies or for which there is no standard therapy are eligible. Patients with primary central nervous system (CNS) tumors are not eligible. Documentation of a RAS Q61X mutation in tumor tissue prior to the first dose of study treatment is required.
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Alabama, United States
University of California, San Francisco, San Francisco, California, United States
Florida Cancer Specialists - St. Petersburg, Saint Petersburg, Florida, United States
Florida Cancer Specialists - Sarasota, Sarasota, Florida, United States
Emory University School of Medicine, Atlanta, Georgia, United States
Henry Ford Health System, Detroit, Michigan, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Comprehensive Cancer Center of Nevada (CCCN), Las Vegas, Nevada, United States
Oregon Health & Science University, Portland, Oregon, United States
SCRI Oncology Partners (formerly Tennessee Oncology), Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Inova Schar Cancer Institute, Fairfax, Virginia, United States
NEXT Virginia, Fairfax, Virginia, United States
University of Wisconsin, Madison, Wisconsin, United States
Macquarie University, Macquarie Park, New South Wales, Australia
St. Vincent's Hospital, Melbourne, Victoria, Australia
Linear Clinical Research, LTD, Perth, , Australia
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
London Regional Cancer Center, London, Ontario, Canada
The Ottawa Hospital, Ottawa, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Princess Margaret Cancer Center, Toronto, Ontario, Canada
Inje University Haeundae Paik Hospital, Busan, Busan Gwang'yeogsi, Korea, Republic of
Samsung Medical Center, Seoul, Seoul Teugbyeolsi, Korea, Republic of
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Hospital Bundang, Gyeonggi-do, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
The Catholic University Hospital, Seoul, , Korea, Republic of
Sarah Cannon Research Institute - HCA Healthcare, City Of London, London, United Kingdom
Beatson West of Scotland Cancer Center, Glasgow, , United Kingdom
Queen's Medical Center, Nottingham, , United Kingdom
Contact Details
Name: Joyce Antal, MS
Affiliation: Clinical Development
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
