Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Bita Fakhri (ucsf)

Description

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.

Official Title

A Phase 1/2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)

Details

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.

Keywords

Chronic Lymphocytic Leukemia, Waldenstrom Macroglobulinemia, Mantle Cell Lymphoma, Marginal Zone Lymphoma, B-cell Lymphoma, Small Lymphocytic Lymphoma, Loxo, LOXO-305, BTK, Bruton's tyrosine kinase, CLL, SLL, NHL, C481S, C481, Ibrutinib, Acalabrutinib, Zanubrutinib, BGB-3111, GS-4059, ONO-4059, Tirabrutinib, Non-Hodgkin Lymphoma, BTK Intolerant, C481S Mutation, DLBCL (Diffuse Large B-cell lymphoma), Follicular Lymphoma, PI3KD, Idelalisib, Umbralisib, BCL2, Venetoclax, Rituximab, Primary CNS Lymphoma, Richter's Transformation, Lymphoma, Leukemia, Lymphoid Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell, Mantle-Cell Lymphoma, Lymphoma, B-Cell, Marginal Zone, Pirtobrutinib

Eligibility

Locations

  • University of California San Francisco, Medical Center at Paranassus
    San Francisco California 94117 United States
  • Scripps Coastal Medical Center
    San Diego California 92103 United States

Lead Scientist at University of California Health

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Loxo Oncology, Inc.
ID
NCT03740529
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
Expecting 860 study participants
Last Updated