A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL
Leukemia
Lymphoma
Non-Hodgkin Lymphoma
18 Years and older, Male and Female
LOXO-BTK-18001 (primary)
NCI-2019-02015
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.
Eligibility
- Histologically confirmed CLL/SLL, WM, or NHL intolerant to either = 2 prior standard of care regimens given in combination or sequentially OR have received 1 prior BTK inhibitor-containing regimen when a BTK inhibitor is approved as first line therapy (Phase 1) OR with prior treatment defined by phase 2 cohort (Phase 2 Patients only).
- Adequate hematologic function (Phase 1 and 1b Patients only).
- Responsive to transfusion support if given for thrombocytopenia or anemia (Phase 1 and 1b Patients only).
- Histologically confirmed relapsed/recurrent CLL in whom venetoclax is appropriate standard salvage treatment; no prior venetoclax is permitted (Phase 1b Arm A Patients only).
- Histologically confirmed relapsed/refractory CLL in whom venetoclax + rituximab is appropriate standard salvage treatment; no prior venetoclax is permitted (Phase 1b Arm B Patients only).
- Eastern Cooperative Oncology Group (ECOG) 0-2.
- Adequate hepatic and renal function.
- Ability to receive study drug therapy orally.
- Willingness of men and women of reproductive potential (defined as following menarche and not postmenopausal [and 2 years of non-therapy-induced amenorrhea] or surgically sterile) to observe conventional and effective birth control.
Treatment Sites in Georgia
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