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Kinase Inhibitor

LOXO-305 for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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.

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Non-Hodgkin's Lymphoma
Lymphoma
Diffuse Large B-Cell Lymphoma
Mantle Cell Lymphoma
MALT Lymphoma
Chronic B-Cell Leukemia
Marginal Zone Lymphoma
Lymphoid Leukemia
B-Cell Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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.

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee

Secondary study objectives

PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)

PAS ORR: ORR Assessed by Investigator

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)

+5 more

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT05176314

Petechiae

Headache

100%

80%

60%

40%

20%

Study treatment Arm

200 mg Pirtobrutinib QD (Days 7-12)

20 mg Rosuvastatin (Day 1)

200 mg Pirtobrutinib QD (Days 14-17)

20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 13)

20 mg Rosuvastatin + 200 mg Pirtobrutinib (Day 6)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: LOXO-305Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LOXO-305

2021

Completed Phase 1

~60

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