A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL

Active:	No
Cancer Type:	Leukemia Lymphoma Non-Hodgkin Lymphoma	NCT ID:	NCT03740529
Trial Phases:	Phase I Phase II	Protocol IDs:	LOXO-BTK-18001 (primary) NCI-2019-02015
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Loxo Oncology, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT03740529

Summary

This is an open-label, multi-center Phase 1/2 study of oral LOXO-305 (pirtobrutinib) in
patients with CLL/SLL and NHL who have failed or are intolerant to standard of care.

Objectives

This study includes 3 parts: Phase 1 (pirtobrutinib monotherapy dose escalation and dose
expansion), Phase 1b (pirtobrutinib combination therapy dose expansion), and Phase 2
(pirtobrutinib monotherapy dose expansion). In Phase 1, patients will be enrolled using
an accelerated titration design. The starting dose of pirtobrutinib in oral tablet form
is 25 mg/day (e.g., 25 mg once daily [QD]). Once the MTD and/or RP2D is identified in
Phase 1 dose escalation, enrollment will continue to Phase 1 dose expansion and can
commence to Phase 1b (Arms A and B). For Phase 2, patients will be enrolled to one of
seven Phase 2 dose expansion cohorts depending on tumor histology and prior treatment
history. Cycle length will be 28 days.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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