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

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04849416
• Other study ID #: 17746
• Secondary ID: J2N-MC-JZNJ
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 14, 2021
• Est. completion date: April 19, 2025

Study information

• Verified date: October 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: April 19, 2025
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• LOXO-305
Administered orally.

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Beijing Cancer hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Sichuan Cancer Hospital	Chengdu
China	Southern Medical University Nanfang Hospital	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Hainan Province People's Hospital	Haikou	Hainan
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang Shi	Henan
China	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Shanghai East Hospital	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Institute of hematology&blood disease hospital	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Affiliated Tumor Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	Wuhan Union Hospital	Wuhan	Hubei
China	Wannan Medical College Yijishan Hospital	Wuhu	Anhui
China	Xi'an International Medical Center Hospital	Xi'an	Shaanxi
China	Xingtai People's Hospital	Xingtai	Hebei
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Loxo Oncology, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	Progression Free Survival (PFS)	PFS	Randomization to Objective Progression or Death Due to Any Cause (Estimated as up to 4 Years
Secondary	Overall Survival (OS)	OS	Randomization to Death from Any Cause (Estimated as up to 4 Years)
Secondary	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)
Secondary	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)
Secondary	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)