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)

简要总结

主要结局

次要结局

• 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))