CA-4948-101: Open-Label, Dose Escalation and Expansion Trial of Emavusertib (CA-4948) in Relapsed or Refractory Primary Central Nervous System Lymphoma (R/R PCNSL)
Start Date
12/28/2017
Completion Date
10/1/2026
Summary
This is a multi-center, open-label study to evaluate the safety, pharmacokinetics (PK), and anti-cancer activity of oral administration of emavusertib alone or in combination with ibrutinib in adult participants with relapsed or refractory (R/R) hematologic malignancies. This trial will be completed in four parts. In Part A1, emavusertib will be evaluated first in a dose escalating monotherapy setting to establish the safety and tolerability (complete). In Part A2, emavusertib will be evaluated in combination with ibrutinib at 560 milligrams (mg) once daily (QD) or 420 mg QD as indicated by disease (Part A2 complete). Part B will comprise 2 cohorts to assess safety and efficacy of emavusertib in combination with ibrutinib in participants with R/R primary central nervous system lymphoma (PCNSL) who have directly progressed on a bruton tyrosine kinase inhibitor (BTKi). In this part of the study, emavusertib will be dosed at 100 mg or 200 mg twice daily (BID) in combination with ibrutinib in 28-day treatment cycles. Part C will comprise 3 treatment arms in the second-line setting to assess the efficacy and safety of emavusertib monotherapy, ibrutinib monotherapy, and emavusertib in combination with ibrutinib in participants with R/R PCNSL who are naïve to BTKi treatment. In this part of the study, eligible second-line participants with R/R PCNSL who are naïve to BTKi treatment will be randomized 1:1:1 to 1 of 3 treatment arms: (1) emavusertib 200 mg BID, (2) ibrutinib 560 mg QD, or (3) emavusertib 200 mg BID in combination with ibrutinib 560 mg QD.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Emavusertib
Ibrutinib
Conditions
Locations
St. Joseph's Hospital and Medical Center
Phoenix, Arizona 85013
United States
Mayo Clinic
Phoenix, Arizona 85054
United States
City of Hope
Duarte, California 91010
United States
Providence St. John's Health Center
Santa Monica, California 90404
United States
UCLA Department of Medicine - Hematology/Oncology
Santa Monica, California 90404
United States
Smilow Cancer Hospital at Yale-New Haven
New Haven, Connecticut 06510
United States
Mayo Clinic
Jacksonville, Florida 32224
United States
Northwestern Memorial Hospital
Chicago, Illinois 60611
United States
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Fred and Pamela Buffett Cancer Center
Omaha, Nebraska 68198
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Roswell Park Comprehensive Cancer Center
Buffalo, New York 14263
United States
Mt Sinai
New York, New York 10029
United States
Columbia University Irving Medical Center
New York, New York 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Duke University Medical Center, Duke Cancer Center
Durham, North Carolina 27710
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Providence Neurological Specialties West
Portland, Oregon 97225
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
UPMC Hilman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
University of Tennessee Medical Center
Knoxville, Tennessee 37920
United States
UT Southwestern Medical Center
Dallas, Texas 75235
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah 84112
United States
Swedish Cancer Institute
Seattle, Washington 98104
United States
University of Washington Medical Center
Seattle, Washington 98195
United States
Všeobecná fakultní nemocnice v Praze
Prague,
Czechia
Institut Bergonie
Bordeaux,
France
Hopital de la Timone
Marseille,
France
Hospital Pitie Salpetriere
Paris,
France
Institut Curie Hospital
Paris,
France
Hematology Department Soroka UMC / Heanatology Department
Beersheba,
Israel
Rambam Medical Center
Haifa,
Israel
Hadassah Medical Center / Ein-Carem
Jerusalem,
Israel
Università di Torino Croce e Carle
Cuneo,
Italy
SODc Ematologia Azienda Ospedaliera Universitaria Careggi
Florence,
Italy
IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Meldola,
Italy
IRCCS San Raffaele Scientific Institute
Milan,
Italy
Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz
Gdansk,
Poland
Oddzial Kliniczny Hematologii
Krakow,
Poland
NarodowyInstytutu Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytutu Badawczy
Warsaw,
Poland
University Hospital Vall d'Hebron
Barcelona,
Spain
MD Anderson Cancer Center Madrid
Madrid,
Spain
Hospital Universitario Virgen del Rocio
Seville,
Spain