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

  1. 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).
  2. Adequate hematologic function (Phase 1 and 1b Patients only).
  3. Responsive to transfusion support if given for thrombocytopenia or anemia (Phase 1 and 1b Patients only).
  4. Histologically confirmed relapsed/recurrent CLL in whom venetoclax is appropriate standard salvage treatment; no prior venetoclax is permitted (Phase 1b Arm A Patients only).
  5. 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).
  6. Eastern Cooperative Oncology Group (ECOG) 0-2.
  7. Adequate hepatic and renal function.
  8. Ability to receive study drug therapy orally.
  9. 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

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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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.