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

Primary Purpose

Leukemia, Lymphoid, Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell

Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
LOXO-305
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia, Lymphoid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wannan Medical College Yijishan Hospital
  • Beijing Cancer hospital
  • Sun Yat-sen University Cancer Center
  • Southern Medical University Nanfang Hospital
  • Hainan Province People's Hospital
  • Affiliated Hospital of Hebei University
  • Xingtai People's Hospital
  • Harbin Medical University Cancer Hospital
  • The First Affiliated Hospital of Henan University of Science &Technology
  • Henan Cancer Hospital
  • Wuhan Union Hospital
  • Xiangya Hospital Central South University
  • Hunan Cancer Hospital
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
  • The First Affiliated Hospital of Soochow University
  • The First Hospital of Jilin University
  • Xi'an International Medical Center Hospital
  • Institute of hematology&blood disease hospital
  • Tianjin Medical University Cancer Institute and Hospital
  • Affiliated Tumor Hospital of Xinjiang Medical University
  • Zhejiang Cancer Hospital
  • Sichuan Cancer Hospital
  • Shanghai East Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LOXO-305

Arm Description

LOXO-305 administered orally.

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
ORR as assessed by an Independent Review Committee (IRC)

Secondary Outcome Measures

ORR: Percentage of Participants Who Achieve CR or PR
ORR as assessed by the Investigator
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
Duration of Response (DOR)
DOR as assessed by the Investigator and IRC
Progression Free Survival (PFS)
PFS
Overall Survival (OS)
OS
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
PK: Maximum Concentration (Cmax) of LOXO-305
PK: Cmax of LOXO-305
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

Full Information

First Posted
April 16, 2021
Last Updated
October 17, 2023
Sponsor
Eli Lilly and Company
Collaborators
Loxo Oncology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04849416
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
April 10, 2023 (Actual)
Study Completion Date
April 19, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
Collaborators
Loxo Oncology, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LOXO-305
Arm Type
Experimental
Arm Description
LOXO-305 administered orally.
Intervention Type
Drug
Intervention Name(s)
LOXO-305
Other Intervention Name(s)
LY3527727, Pirtobrutinib
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
ORR as assessed by an Independent Review Committee (IRC)
Time Frame
Randomization through Measured Progressive Disease (Estimated as up to 4 Years)
Secondary Outcome Measure Information:
Title
ORR: Percentage of Participants Who Achieve CR or PR
Description
ORR as assessed by the Investigator
Time Frame
Randomization through Measured Progressive Disease (Estimated as up to 4 Years)
Title
Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD)
Description
BOR as assessed by the Investigator and IRC
Time Frame
Randomization to Date of Objective Disease Progression (Estimated as up to 4 Years)
Title
Duration of Response (DOR)
Description
DOR as assessed by the Investigator and IRC
Time Frame
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)
Title
Progression Free Survival (PFS)
Description
PFS
Time Frame
Randomization to Objective Progression or Death Due to Any Cause (Estimated as up to 4 Years
Title
Overall Survival (OS)
Description
OS
Time Frame
Randomization to Death from Any Cause (Estimated as up to 4 Years)
Title
7. Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve from Time Zero to last (AUC[0-t) of LOXO-305
Description
PK: AUC(0-t) of LOXO-305
Time Frame
Cycle 1 Day 1 Predose through Cycle 4 Day 1 Postdose (Cycle = 28 Days)
Title
PK: Maximum Concentration (Cmax) of LOXO-305
Description
PK: Cmax of LOXO-305
Time Frame
Cycle 1 Day 1 Predose through Cycle 4 Day 1 Postdose (Cycle = 28 Days)
Title
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)
Description
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
Time Frame
Baseline through End of Treatment (Estimated as up to 3 Years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Wannan Medical College Yijishan Hospital
City
Wuhu
State/Province
Anhui
ZIP/Postal Code
241001
Country
China
Facility Name
Beijing Cancer hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Southern Medical University Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Hainan Province People's Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570100
Country
China
Facility Name
Affiliated Hospital of Hebei University
City
Baoding
State/Province
Hebei
ZIP/Postal Code
071030
Country
China
Facility Name
Xingtai People's Hospital
City
Xingtai
State/Province
Hebei
ZIP/Postal Code
054031
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
The First Affiliated Hospital of Henan University of Science &Technology
City
Luoyang Shi
State/Province
Henan
ZIP/Postal Code
471003
Country
China
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Facility Name
Wuhan Union Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Facility Name
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215066
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Xi'an International Medical Center Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710126
Country
China
Facility Name
Institute of hematology&blood disease hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Affiliated Tumor Hospital of Xinjiang Medical University
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
830002
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Sichuan Cancer Hospital
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Shanghai East Hospital
City
Shanghai
ZIP/Postal Code
200120
Country
China

12. IPD Sharing Statement

Plan to Share 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 URL
http://vivli.org/

Learn more about this trial

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

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