Spots Global Cancer Trial Database for Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas
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Trial Identification
Brief Title: Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas
Official Title: Phase 1-2 Study of the Safety, Pharmacokinetics, and Preliminary Activity of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas
Study ID: NCT02503423
Interventions
Study Description
Brief Summary: This is an open-label, dose-escalation Phase 1/2 study to assess the safety of ASTX660, determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), and recommended dosing regimen, and to obtain preliminary efficacy, pharmacokinetic (PK), and target engagement data, in subjects with advanced solid tumors or lymphoma for whom standard life-prolonging measures are not available.
Detailed Description: ASTX660 is a synthetic small molecule dual antagonist of cellular inhibitor of apoptosis protein (cIAP) 1 and X-linked inhibitor of apoptosis protein (XIAP) that has been shown to have potent proapoptotic and tumor growth inhibitory activity in nonclinical models. The Phase 1 portion of the study (completed) will determine the MTD, RP2D, and recommended dosing regimen. The Phase 2 portion will evaluate activity in selected tumor types. Subjects will continue to receive their assigned treatment throughout the study until the occurrence of disease progression, death, or unacceptable treatment-related toxicity, or until the study is closed by the sponsor.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
HonorHealth Research Institute, Scottsdale, Arizona, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Cedars-Sinai Medical Center, Los Angeles, California, United States
UC Davis Medical Center, Sacramento, California, United States
Simlow Cancer Hospital at Yale, New Haven, Connecticut, United States
Emory University winship Cancer Institute, Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois, United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Dartmouth-Hitchcock Medical Center (DHMC), Lebanon, New Hampshire, United States
Summit Medical Group - Florham Park Campus/Atlantic Health, Florham Park, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
New York University Langone Medical Center, New York, New York, United States
New York Presbyterian Hospital Columbia University Medical Center, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Rochester Skin Lymphoma Medical Group, Rochester, New York, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
The Ohio State University and Wexner Medical Center, James Cancer Hospital, Columbus, Ohio, United States
University of Oklahoma Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Oregon Health and Science University, Portland, Oregon, United States
West Penn Hospital, Pittsburgh, Pennsylvania, United States
Hollings Cancer Center, Charleston, South Carolina, United States
Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
MD Anderson Cancer Center, Houston, Texas, United States
CliniCore Texas, Houston, Texas, United States
START- South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States
Virgina Commonwealth University, Richmond, Virginia, United States
University of Washington, Seattle Cancer Care Alliance, Seattle, Washington, United States
Centre Hospitalier Universitaire Universite Catholique de Louvain - Site Godinne, Yvoir, Namur, Belgium
Universitair Ziekenhuis Gent, Gent, Oost-Vlaanderen, Belgium
Intitut Jules Boredt, Bruxelles, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
British Columbia Cancer Agency, Vancouver, British Columbia, Canada
Cancer Care Manitoba, Winnipeg, Manitoba, Canada
Nova Scotia Health Athority-Qeii HSC, Halifax, Nova Scotia, Canada
Sunnybrook Hospital, Toronto, Ontario, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montréal, Quebec, Canada
Gustave Roussy Cancer Campus (IGR), Villejuif, Cedex, France
Centre Hospitalier Lyon Sud, Pierre-Bénite, Lyon, France
Institut Bergonié, Unicancer, Bordeaux, , France
Centre Antoine Lacassagne, Oncologie Médicale, Nice, , France
Centre Henri Becquerel, Hematology, Rouen, , France
Institut Universitaire du Cancer - Oncopôle, Department d'Hématologie, Toulouse Cedex 9, , France
CRU de Tours - Hôpital Bretonneau, Hématologie -Thérapy Cellulaire, Tours, , France
Semmelweis Egyetem - I. sz. Belgyógyászati Klinika, Budapest, , Hungary
Debreceni Egyetem Klinikai Központ, Debrecen, , Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak És Egyetemi Oktatókórház, Nyíregyháza, , Hungary
Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi, Bologna, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia, , Italy
Instituto Europeo di Oncologia, Milan, , Italy
Azienda Socio Santaria Territoriale Monza- Osperdale San Gerado, Monza, , Italy
Institut Catala d'Oncologia, Girona, Giona, Spain
imCORE - Clínica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital Universitario Fundacion Jimenez Diaz Preview, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
University Hospitals of Leicester NHS Trust, Leicester, East Midlands, United Kingdom
University Hospital Southhampton NHS Foundation Trust - Somers Cancer Research, Southampton, Hampshire, United Kingdom
Churchill Hospital, Oxford University Hospital NHS Trust, Oxford, Oxfordshire, United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital, Birmingham, , United Kingdom
Beatson Cancer Center and University of Glasgow, Glasgow, , United Kingdom
University College London Hospitals NHS Foundation Trust, London, , United Kingdom
Guy's and Saint Thomas' NHS Foundation Trust, London, , United Kingdom
The Christie NHS Foundation Trust, Christie Hospital, Manchester, , United Kingdom
Contact Details
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