Spots Global Cancer Trial Database for Study of ASTX029 in Subjects With Advanced Solid Tumors
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Trial Identification
Brief Title: Study of ASTX029 in Subjects With Advanced Solid Tumors
Official Title: A Phase 1-2 Study of the Safety, Pharmacokinetics, and Activity of ASTX029 in Subjects With Advanced Solid Tumors
Study ID: NCT03520075
Conditions
Interventions
Study Description
Brief Summary: This study is a first-in-human, open-label, multicenter, Phase 1-2 study to assess the safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of ASTX029 administered orally to subjects with advanced solid malignancies who are not candidates for approved or available therapies.
Detailed Description: ASTX029 is a synthetic small molecule inhibitor of extracellular signal-regulated kinases (ERKs) 1/2. ASTX029 has not been previously evaluated in human subjects. The Phase 1 portion of this study will assess safety and determine the maximum tolerated dose, the recommended Phase 2 dose (RP2D), and the recommended dosing regimen of ASTX029 administered orally. The Phase 2 portion will assess preliminary clinical activity in tumors characterized by gene aberrations in the mitogen-activated protein kinase (MAPK) signal pathway that may confer sensitivity to ASTX029.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope Comprehensive Cancer Center, Duarte, California, United States
University of Southern California Norris Comprehensive Cancer Center Site#114, Los Angeles, California, United States
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute Site# 107, Los Angeles, California, United States
Hoag Memorial Hospital Site#115, Newport Beach, California, United States
University of California Davis Medical Center Site #121, Sacramento, California, United States
California Pacific Medical Center - Sutter Pacific Medical Center Site#117, San Francisco, California, United States
Smilow Cancer Hospital at Yale New Haven Site#105, New Haven, Connecticut, United States
Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
The Sidney Kimmel Comprehensive Cancer Center Site#106, Baltimore, Maryland, United States
Massachusetts General Hospital Site#103, Boston, Massachusetts, United States
Dana Farber Cancer Institute Site#104, Boston, Massachusetts, United States
University of Michigan Rogel Cancer Center Site #113, Ann Arbor, Michigan, United States
Columbia University Irving Medical Center - Herbert Irving Pavilion Site#112, New York, New York, United States
Providence Portland Medical Center Site #118, Portland, Oregon, United States
Oregon Health and Science University Site #122, Portland, Oregon, United States
University of Pennsylvania-Abramson Cancer Center, Philadelphia, Pennsylvania, United States
The University of Texas MD Anderson Cancer Center Site#111, Houston, Texas, United States
START - South Texas Accelerated Research Therapeutics, LLC Site# 101, San Antonio, Texas, United States
Virginia Cancer Specialists Site#102, Fairfax, Virginia, United States
Centre Léon Bérard Service d'Oncologie Médicale Site#202, Lyon, Rhone-Alpes, France
Hôpital de la Timone Site #201, Marseille, , France
Institut Català d'Oncologia Badalona Site#240, Barcelona, , Spain
Hospital Universitari Vall d'Hebrón Servicio de Oncología, Sala coordinación UITM Site#243, Barcelona, , Spain
Hospital Universitari Germans Trias i Pujol, Barcelona, , Spain
Hospital Universitario Dexeus Site#241, Barcelona, , Spain
Clinica Universidad de Navarra Madrid Site #242, Madrid, , Spain
Clínica Universidad de Navarra Site#242, Madrid, , Spain
The Christie NHS Foundation Trust Site#220, Manchester, England, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Site #221, Newcastle Upon Tyne, , United Kingdom
Churchill Hospital Site #224, Oxford, , United Kingdom
Contact Details
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