Spots Global Cancer Trial Database for Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
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Trial Identification
Brief Title: Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
Official Title: A Phase 1 Study of Oral LOXO-338, a Selective BCL-2 Inhibitor, in Patients With Advanced Hematologic Malignancies
Study ID: NCT05024045
Study Description
Brief Summary: The purpose of this study is to find out whether the study drug, LOXO-338, is safe and effective in patients with advanced blood cancer. Patients must have already received standard therapy. The study may last up to approximately 3 years.
Detailed Description: This study will be conducted in 2 parts. Part 1 will evaluate LOXO-338 as monotherapy. If safety and initial evidence of efficacy of LOXO-338 monotherapy are confirmed, part 2 will evaluate the combination of LOXO-338 with the highly selective, noncovalent Bruton's tyrosine kinase (BTK) inhibitor, pirtobrutinib (LOXO-305).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Arizona Cancer Center, Tucson, Arizona, United States
City of Hope National Medical Center, Duarte, California, United States
University of California San Francisco, Medical Center at Paranassus, San Francisco, California, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Emory University, Atlanta, Georgia, United States
Indiana Blood & Marrow Transplantation (IBMT), Indianapolis, Indiana, United States
University of Kansas Medical Center, Westwood, Kansas, United States
Tufts Medical Center, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Swedish Medical Center, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
L'Institut Universitaire du Cancer de Toulouse Oncopole, Toulouse, Cedex 9, France
Centre Hospitalier Lyon Sud, Pierre-Bénite, Cedex, France
CHRU de Montpellier-Hopital St Eloi, Montpellier Cedex 5, , France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu, Nantes, , France
Institut Curie, Paris, , France
Centre hospitalier universitaire de Haut Leveque, Pessac Cedex, , France
IRCCS - AOU di Bologna, Bologna, , Italy
Centrum Medyczne Pratia Poznan, Skorzewo, Poznan, Poland
Pratia MCM Krakow, Krakow, , Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy, Warszawa, , Poland
Contact Details
Name: James Pauff, MD; PhD
Affiliation: Loxo Oncology, Inc.
Role: STUDY_DIRECTOR
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