Study of Oral LOXO-338 in Patients With Advanced Blood Cancers (NCT05024045) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
United States316 participantsStarted 2021-09-30
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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.
Exclusion Criteria:
* Prior to identification of an appropriate RP2D (Dose Expansion) of LOXO-338, a history of known, active or suspected:
* Richter's transformation to diffuse large B-cell…
What they're measuring
1
Part 1 - To determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of oral LOXO-338
Timeframe: Cycle 1 (28 Days)
2
Part 1 - To determine the effect of LOXO-338 on response rates
Timeframe: Estimated up to 2 years
3
Part 2 - To determine the safety and tolerability of LOXO-338 when given in combination with pirtobrutinib