Condition: Relapsed Hematologic Malignancy · Refractory Hematologic Malignancy · Relapsed Primary Central Nervous System Lymphoma · Sponsor: Curis, Inc.
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 …
This description comes directly from the study's public registry record.
Ahmed Hamdy, MD · 617-503-6500 · clinicaltrials@curis.com
Always discuss trial participation with your own doctor first.
| St. Joseph's Hospital and Medical Center | Phoenix, Arizona, United States | Recruiting |
| Mayo Clinic | Phoenix, Arizona, United States | Completed |
| City of Hope | Duarte, California, United States | Recruiting |
| Providence St. John's Health Center | Santa Monica, California, United States | Recruiting |
| UCLA Department of Medicine - Hematology/Oncology | Santa Monica, California, United States | Withdrawn |
| Smilow Cancer Hospital at Yale-New Haven | New Haven, Connecticut, United States | Completed |
| Mayo Clinic | Jacksonville, Florida, United States | Recruiting |
| Northwestern Memorial Hospital | Chicago, Illinois, United States | Recruiting |
| Dana Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
| Mayo Clinic | Rochester, Minnesota, United States | Recruiting |
| Fred and Pamela Buffett Cancer Center | Omaha, Nebraska, United States | Recruiting |
| Hackensack University Medical Center | Hackensack, New Jersey, United States | Completed |
+ 33 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT03328078