NCT04849416CompletedPhase 2
A Phase 2 Study of Oral LOXO-305 in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) or Non-Hodgkin Lymphoma (NHL)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 87
- Locations
- 22
- Primary Endpoint
- Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee
Study Overview
Brief Summary
A study of the safety, side effects, and effectiveness of LOXO-305 in Chinese adults with lymphoma or chronic leukemia who have already had standard of care treatment. Participation could last up to four years.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with histologically confirmed B-cell malignancy including:
- •Mantle cell lymphoma (MCL) treated with a prior Bruton's tyrosine kinase (BTK) inhibitor containing regimen;
- •CLL/SLL treated with a prior BTK inhibitor containing regimen;
- •Other types of B-cell NHL
- •All participants must have disease requiring treatment, for CLL/SLL participants, at least 1 indication for treatment consistent with IWCLL 2018 criteria is required
- •Eastern Cooperative Oncology Group 0-2
- •Adequate hematologic status, coagulation, hepatic and renal function
Exclusion Criteria
- •Lack of adequate wash-out period for investigational agent or anticancer therapy, major surgery, and radiotherapy prior to the first dose of study treatment
- •Participants requiring therapeutic anticoagulation with warfarin
- •Known central nervous system (CNS) involvement by systemic lymphoma. Primary CNS lymphoma is excluded
- •Significant cardiovascular disease
- •Prolongation of the QT interval
- •Test positive for human immunodeficiency virus (HIV)
- •Current treatment with certain strong cytochrome P450 3A4 (CYP450 3A4) inhibitors or inducers and/or strong p-glycoprotein (P-gp) inhibitors
- •Pregnancy or lactation
- •Active second malignancy
- •Prior treatment with LOXO-305
- •Known hypersensitivity to any component or excipient of LOXO-305
Arms & Interventions
LOXO-305
Experimental
Participants received 200 mg of LOXO-305 administered orally once daily (QD) on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
Intervention: LOXO-305 (Drug)
Outcomes
Primary Outcomes
Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee
Time Frame: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)
ORR was assessed by an Independent Review Committee (IRC). It was estimated based on the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). Two-sided 95% CI was calculated using the exact binomial distribution. PAS consisted of participants with Central histologically confirmed non-blastoid MCL, with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, measurable disease at baseline as assessed using Lugano criteria, and have received at least 1 dose of study drug.
Secondary Outcomes
- PAS ORR: ORR Assessed by Investigator(Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks))
- PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)(Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks))
- PAS: Duration of Response (DOR)(Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 100 Weeks))
- PAS: Progression Free Survival (PFS)(Date of First Dose to Progressive Disease or Death from Any Cause (Up to 100 weeks))
- PK: Maximum Concentration (Cmax) of LOXO-305(Cycle 1 Day 1: Predose, 1, 2, 4, 8, 12, 24 hours(h) postdose; Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 2 Day 1: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 4 Day 1: Predose, 1, 2, 4, 8 h postdose.)
- PAS: Overall Survival (OS)(Date of First Dose to Date of Death from Any Cause (Up to 100 weeks))
- Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration(AUC[0-tlast] of LOXO-305(Cycle 1 Day 1: Predose, 1, 2, 4, 8, 12, 24 hours(h) postdose; Cycle 1 Day 8: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 2 Day 1: Predose, 1, 2, 4, 8, 24 h postdose; Cycle 4 Day 1: Predose, 1, 2, 4, 8 h postdose.)
- PAS: Change From Baseline in Disease-Related Symptoms and Health-Related Quality of Life (HRQoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(Baseline, 7 Days After Treatment Discontinuation (Up To 100 Weeks))
Investigators
Study Sites (22)
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