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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
NCT 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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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