A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)

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)

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 Overview

• Status: Active, not recruiting
• Conditions: Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
• Intervention / Treatment: Drug: LOXO-305

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Chengdu, China, 610041
    • Sichuan Cancer Hospital
  • Shanghai, China, 200120
    • Shanghai East Hospital
  • Anhui
    • Wuhu, Anhui, China, 241001
      • Wannan Medical College Yijishan Hospital
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Center
    • Guangzhou, Guangdong, China, 510515
      • Southern Medical University Nanfang Hospital
  • Hainan
    • Haikou, Hainan, China, 570100
      • Hainan Province People's Hospital
  • Hebei
    • Baoding, Hebei, China, 071030
      • Affiliated Hospital of Hebei University
    • Xingtai, Hebei, China, 054031
      • Xingtai People's Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin medical university cancer hospital
  • Henan
    • Luoyang Shi, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science &Technology
    • Zhengzhou, Henan, China, 450008
      • Henan Cancer Hospital
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer hospital
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
    • Suzhou, Jiangsu, China, 215066
      • The First Affiliated Hospital of Soochow University
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710126
      • Xi'an International Medical Center Hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University Cancer Institute and Hospital
    • Tianjin, Tianjin, China, 300020
      • Institute of hematology&blood disease hospital
  • Xinjiang
    • Urumqi, Xinjiang, China, 830002
      • Affiliated Tumor Hospital of Xinjiang Medical University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LOXO-305; LOXO-305 administered orally.	Drug: LOXO-305; Administered orally.; Other Names: LY3527727; Pirtobrutinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Response Rate (ORR)	ORR as assessed by an Independent Review Committee (IRC)	Randomization through Measured Progressive Disease (Estimated as up to 4 Years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR: Percentage of Participants Who Achieve CR or PR	ORR as assessed by the Investigator	Randomization through Measured Progressive Disease (Estimated as up to 4 Years)
Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)	BOR as assessed by the Investigator and IRC	Randomization to Date of Objective Disease Progression (Estimated as up to 4 Years)
Duration of Response (DOR)	DOR as assessed by the Investigator and IRC	Date of Partial Response (PR) or Better (PR with lymphocytosis or better for CLL/SLL, minor response or better for Waldenström macroglobulinemia) to Date of Disease Progression or Death Due to Any Cause (Estimated as up to 4 Years)
Progression Free Survival (PFS)	PFS	Randomization to Objective Progression or Death Due to Any Cause (Estimated as up to 4 Years
Overall Survival (OS)	OS	Randomization to Death from Any Cause (Estimated as up to 4 Years)
7. Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve from Time Zero to last (AUC[0-t) of LOXO-305	PK: AUC(0-t) of LOXO-305	Cycle 1 Day 1 Predose through Cycle 4 Day 1 Postdose (Cycle = 28 Days)
PK: Maximum Concentration (Cmax) of LOXO-305	PK: Cmax of LOXO-305	Cycle 1 Day 1 Predose through Cycle 4 Day 1 Postdose (Cycle = 28 Days)
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)	Five physical function items identified in the EORTC-QLQ-C30 questionnaire (also known as the EORTC IL 19 questionnaire), will be measured. Raw scores for these items range from 0-20, with the highest score indicating worst function	Baseline through End of Treatment (Estimated as up to 3 Years)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Collaborators: Loxo Oncology, Inc.
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2021
• Primary Completion (Actual): April 10, 2023
• Study Completion (Estimated): April 19, 2025

Study Registration Dates

• First Submitted: April 16, 2021
• First Submitted That Met QC Criteria: April 16, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Disease Attributes; Leukemia, B-Cell; Chronic Disease; Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse; Leukemia; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Pirtobrutinib
• Other Study ID Numbers: 17746; J2N-MC-JZNJ (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting
• IPD Sharing Access Criteria: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes