Spots Global Cancer Trial Database for A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL
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 of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL
Official Title: A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)
Study ID: NCT03740529
Study Description
Brief Summary: This is an open-label, multi-center Phase 1/2 study of oral LOXO-305 (pirtobrutinib) in patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.
Detailed Description: This study includes 3 parts: Phase 1 (pirtobrutinib monotherapy dose escalation and dose expansion), Phase 1b (pirtobrutinib combination therapy dose expansion), and Phase 2 (pirtobrutinib monotherapy dose expansion). In Phase 1, patients will be enrolled using an accelerated titration design. The starting dose of pirtobrutinib in oral tablet form is 25 mg/day (e.g., 25 mg once daily \[QD\]). Once the MTD and/or RP2D is identified in Phase 1 dose escalation, enrollment will continue to Phase 1 dose expansion and can commence to Phase 1b (Arms A and B). For Phase 2, patients will be enrolled to one of seven Phase 2 dose expansion cohorts depending on tumor histology and prior treatment history. Cycle length will be 28 days.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Clinic of Scottsdale, Scottsdale, Arizona, United States
Scripps Coastal Medical Center, San Diego, California, United States
University of California San Francisco, Medical Center at Paranassus, San Francisco, California, United States
Smilow Cancer Hospital at Yale-New Haven, New Haven, Connecticut, United States
Mayo Clinic-Jacksonville, Jacksonville, Florida, United States
Florida Cancer Specialists ORLANDO/DDU, Lake Mary, Florida, United States
Sylvester Comprehensive Cancer Center, Miami, Florida, United States
Florida Cancer Specialists, Sarasota, Florida, United States
Emory Clinic, Atlanta, Georgia, United States
Northwestern University, Chicago, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Mayo Clinic, Rochester, Minnesota, United States
University of Nebraska Medical Center, Omaha, Nebraska, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Northwell Health, New Hyde Park, New York, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Durham VA Medical Center, Durham, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Hospital, Columbus, Ohio, United States
University of Pennsylvania Hospital, Philadelphia, Pennsylvania, United States
Sarah Cannon Research Institute SCRI, Nashville, Tennessee, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Swedish Medical Center, Seattle, Washington, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
Flinders Medical Centre, Bedford Park, South Australia, Australia
Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia
Linear Clinical Research, Nedlands, Western Australia, Australia
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu, Nantes Cedex 1, , France
IRCCS - AOU di Bologna, Bologna, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
Nagoya Medical Center, Nagoya, Aichi, Japan
Hokkaido University Hospital, Sapporo, Hokkaido, Japan
Tokai University Hospital- Isehara Campus, Isehara, Kanagawa, Japan
Kochi Medical School Hospital, Nankoku, Kochi, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
National Cancer Center Hospital, Chuo Ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Kyoto Furitsu Medical University Hospital, Kyoto, , Japan
Okayama University Hospital, Okayama, , Japan
Kindai University Hospital, Osakasayama-Shi, , Japan
Samsung Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Pratia MCM Krakow, Krakow, , Poland
Instytut Hermatologii I Transfuzjologii, Warszawa, , Poland
Karolinska Institutet, Solna, AB, Sweden
Ospedale Regionale Bellinzona e Valli, Bellinzona, Ticino, Switzerland
St James's University Hospital, Leeds, , United Kingdom
Churchill Hospital, Oxford, , United Kingdom
Derriford Hospital, Plymouth, , United Kingdom
Contact Details
Name: Donald Tsai, MD, PhD
Affiliation: Loxo Oncology
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:
