Title: A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL
Study Director: Nora Ku, MD, LOXO Oncology, South San Francisco, California
Description: This trial is a multicenter, open-label, phase 1/2 study of oral LOXO-305 in patients with chronic lymphocytic leukemia/small lymphocytic leukemia and non-Hodgkin lymphoma who are either intolerant to or for whom standard of care therapy has failed. This study includes two phases: dose escalation (phase 1) and dose expansion (phase 2). During phase 1 of the trial, patients will be enrolled using an accelerated titration design. The starting dose of LOXO-305 in oral tablet form is 25 mg/day. Once the maximum tolerated dose and/or highest dose with acceptable toxicity is identified, patients will be enrolled to 1 of 6 phase 2 dose expansion cohorts depending on tumor histology, tumor genotype, and prior treatment history. The cycle length will be 28 days.
Status: This study is open and recruiting patients as of November 16, 2018.
This study is sponsored by Loxo Oncology, Inc.
Clinicaltrials.gov. A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL. NCT03740529. https://clinicaltrials.gov/ct2/show/NCT03740529. Accessed June 24, 2019.