Clinical trial NCT04849416: A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Leukemia, Lymphoid
Lymphoma, Non-Hodgkin
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, B-Cell
Lymphoma, B-Cell, Marginal Zone
Leukemia, Lymphocytic, Chronic, B-Cell
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Loxo Oncology, Inc.
First posted: 2021-04-19
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee
timeFrame: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)
Secondary outcomes:
measure: PAS ORR: ORR Assessed by Investigator
timeFrame: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)
measure: PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE)
timeFrame: Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks)
measure: PAS: Duration of Response (DOR)
timeFrame: Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 100 Weeks)
measure: PAS: Progression Free Survival (PFS)
timeFrame: Date of First Dose to Progressive Disease or Death from Any Cause (Up to 100 weeks)
measure: PAS: Overall Survival (OS)
timeFrame: Date of First Dose to Date of Death from Any Cause (Up to 100 weeks)
measure: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration(AUC[0-tlast] of LOXO-305
timeFrame: 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.
measure: PK: Maximum Concentration (Cmax) of LOXO-305
timeFrame: 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.
measure: 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)
timeFrame: Baseline, 7 Days After Treatment Discontinuation (Up To 100 Weeks)
Other outcomes:
Locations:
city: Wuhu
country: China
facility: Wannan Medical College Yijishan Hospital
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer hospital
state: Beijing
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Baoding
country: China
facility: Affiliated Hospital of Hebei University
state: Hebei
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Luoyang Shi
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Xi'an
country: China
facility: Xi'an International Medical Center Hospital
state: Shaanxi
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Tianjin
country: China
facility: Institute of hematology&blood disease hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Urumqi
country: China
facility: Xinjiang Medical University Cancer Hospital - Urumqi
state: Xinjiang
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Shanghai
country: China
facility: Shanghai East Hospital
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: