Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
Leukemia
Lymphoma
Multiple Myeloma
Non-Hodgkin Lymphoma
Plasma cell neoplasm
18 Years and older, Male and Female
LOXO-BCL-20001 (primary)
NCI-2021-10661
2021-000060-30
J3N-OX-JZRA
Summary
The purpose of this study is to find out whether the study drug, LOXO-338, is safe and
effective in patients with advanced blood cancer. Patients must have already received
standard therapy. The study may last up to approximately 3 years.
Objectives
This study will be conducted in 2 parts. Part 1 will evaluate LOXO-338 as monotherapy. If
safety and initial evidence of efficacy of LOXO-338 monotherapy are confirmed, part 2 will
evaluate the combination of LOXO-338 with the highly selective, noncovalent Bruton's tyrosine
kinase (BTK) inhibitor, pirtobrutinib (LOXO-305).
Eligibility
- B-cell malignancy.
- Patients must have received prior therapy.
- Patients must have an objective indication for therapy.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
- Anticipated life expectancy of greater than or equal to (=) 12 weeks.
- Adequate bone marrow function.
- Adequate hepatic function.
- Creatinine clearance of = 60 milliliters (mL)/minute.
- Ability to swallow tablets.
- Ability to comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
- Prior treatment-related adverse events (AEs) must have recovered to grade less than or equal to (=) 1 or pretreatment baseline, with the exception of alopecia.
- Men with partners of childbearing potential or women of childbearing potential (WOCBP) must agree to use highly effective birth control.
- WOCBP must not be pregnant.
- Additional Inclusion Criteria for Patients with AL Amyloidosis
- In Part 1 Dose Expansion, patients with AL amyloidosis are eligible based on prior detection of primary systemic light-chain amyloidosis.
- Must have measurable disease of AL amyloidosis.
- Prior local fluorescence in-situ hybridization (FISH) testing results for t(11;14) are required to be submitted prior to enrollment.
Treatment Sites in Georgia
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