The purpose of this study is to determine the dose that can be safely given to see what effect it may have on your cancer and to determine how the drug is distributed in the body.
A Phase 1, sequential dose escalation followed by cohort expansion study of CAL-101, an oral inhibitor of PI3K delta, in patients with relapsed or refractory CLL, select B-cell NHL and AML.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
192
CAL-101 50, 100, 150, 200, 350 mg capsules BID for 28 days CAL-101 150, 300 mg QD for 28 days CAL-101 150 mg BID 3 weeks on 1 week off for 28 days
Stanford Cancer Center
Palo Alto, California, United States
The Sidney Kimmel Comprehensive Cancer Center at John Hopkins
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
To evaluate the safety of CAL-101 and determine the dose limiting toxicity in patients with hematologic malignancies.
Time frame: 28 days
To evaluate the pharmacokinetic parameters, pharmacodynamic effects and clinical response rate following CAL-101 treatment in patients with hematologic malignancies.
Time frame: 28 Days
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Washington University School of Medicine
St Louis, Missouri, United States
Weill Medical College of Cornell
New York, New York, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
University of Wisconsin
Madison, Wisconsin, United States