Phase 1b, Escalating Dose Study of AVL-292, a Bruton's Tyrosine Kinase (Btk) Inhibitor, as Monotherapy in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia
Bruton's tyrosine kinase (Btk) is non-receptor tyrosine kinase with restricted cellular
expression largely limited to B-lymphocytes, monocytes, and mast cells or basophils. Btk is
a critical component of the B cell receptor (BCR) signaling network and is crucial for B
cell development. Investigation has revealed that some B cell lymphomas and CLL depend on
BCR signaling, suggesting that interruption of such signaling could be a promising
therapeutic opportunity in B-NHL, CLL and WM.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety, tolerability,and dose limiting toxicities will be determined using AEs,PE,ophthalmologic examinations,clinical laboratory tests,vital signs, ECGs and echocardiograms/MUGA scans.
with in the first 28 days after initiation of once daily oral dosing
No
United States: Food and Drug Administration
AVL-292-003
NCT01351935
June 2011
June 2014
Name | Location |
---|---|
University of Rochester Medical Center | Rochester, New York 14642 |
Mayo Clinic | Jacksonville, Florida 32224 |
Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
Northwestern University | Chicago, Illinois 60611 |
Cleveland Clinic | Cleveland, Ohio 44195 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
Clearview Cancer Institute | Huntsville, Alabama 35805 |
Horizon Oncology Center | Lafayette, Indiana 47905 |
University of Texas Health Science Center, San Antonio | San Antonio, Texas 78229 |
University of Arizona (SPORE) | Tucson, Arizona 85719 |
Mount Sinai School of Medicine & Mount Sinai Graduate School of biological Sciences | New York, New York 10029 |
US Oncology Research: Willamette Valley Cancer Institute and Research Center | Springfield, Oregon 97477 |