A Phase 1/2 Study of Oral LOXO-305 in Patients withPreviously Treated Chronic Lymphocytic Leukemia/SmallLymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin’sLymphoma (NHL)

Protocol: 
AAAS3311
Phase: 
I/II

A Phase 1/2 Study of Oral LOXO-305 in Patients withPreviously Treated Chronic Lymphocytic Leukemia/SmallLymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin’sLymphoma (NHL)

This research study is being done to test the safety of an investigational
treatment called LOXO-305. LOXO-305 is an investigational drug that may
treat certain cancers like leukemias and lymphomas, including the one you
have been diagnosed with.

These cancers are dependent on or “addicted to” a protein made by the
cancers called “BTK”. LOXO-305 is a “BTK inhibitor”—it is designed to block
both normal and mutated forms of BTK in these cancers, including cancers
against which available BTK inhibitors (e.g. ibrutinib, acalabrutinib) have
stopped working.

The purpose of this research study includes the following.
• To determine whether LOXO-305 is safe
• To identify the dose of LOXO-305 that should be used in future studies
• To identify the highest tolerable dose of LOXO-305
• To evaluate how the body absorbs and processes different doses of LOXO-305
by measuring the levels of LOXO-305 in the blood at different times. This
is called pharmacokinetics (PK) testing.
• To determine how well your cancer responds to treatment with LOXO-305
• To determine how long any benefits from treatment with LOXO-305 last

Are you Eligible? (Inclusion Criteria)

1. Does you have histologically confirmed CLL/SLL or NHL failed or
intolerant to standard of
care therapies?
2. Have you recieved >= 2 prior lines of therapy?
3. Are you at least 18 years of age?
4. Do you have the ability to swallow tablets and comply with outpatient
treatment,
laboratory monitoring, and required clinic visits for the duration of study
participation?

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States