A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)
NCT ID: NCT04849416
Last Updated: 2025-06-18
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
87 participants
INTERVENTIONAL
2021-05-14
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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LOXO-305
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.
LOXO-305
Administered orally.
Interventions
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LOXO-305
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Loxo Oncology, Inc.
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Wannan Medical College Yijishan Hospital
Wuhu, Anhui, China
Beijing Cancer hospital
Beijing, Beijing Municipality, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Hainan General Hospital
Haikou, Hainan, China
Affiliated Hospital of Hebei University
Baoding, Hebei, China
Xingtai People's Hospital
Xingtai, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
Luoyang Shi, Henan, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Medical University Cancer Hospital - Urumqi
Ürümqi, Xinjiang, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Shanghai East Hospital
Shanghai, , China
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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J2N-MC-JZNJ
Identifier Type: OTHER
Identifier Source: secondary_id
17746
Identifier Type: -
Identifier Source: org_study_id
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