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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's Lymphoma (NHL)

Status
Active
Cancer Type
Leukemia
Lymphoma
Non-Hodgkin Lymphoma
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03740529
Protocol IDs
LOXO-BTK-18001 (primary)
NCI-2019-02015
Study Sponsor
Loxo Oncology, Inc.

Summary

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

Objectives

This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, patients will be enrolled using an accelerated titration design. The starting dose of LOXO-305 in oral tablet form is 25 mg/day (e.g., 25 mg once daily [QD]). Once the MTD and/or RP2D is identified, patients will be enrolled to one of six phase 2 dose expansion cohorts depending on tumor histology, tumor genotype, and prior treatment history. Cycle length will be 28 days.
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