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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04849416
• Collaborator: Loxo Oncology, Inc. (Industry)
• Enrollment: 126
• Locations: 23
• Arm: 1
• Anticipated Duration (Months): 47.2
• Patients Per Site: 5.5
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
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	Drug: LOXO-305	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 126 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: May 14, 2021
• Anticipated Primary Completion Date: Jun 30, 2023
• Anticipated Study Completion Date: Apr 19, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Overall Response Rate (ORR) [Randomization through Measured Progressive Disease (Estimated as up to 4 Years)]

   ORR as assessed by an Independent Review Committee (IRC)

Secondary Outcome Measures

1. ORR: Percentage of Participants Who Achieve CR or PR [Randomization through Measured Progressive Disease (Estimated as up to 4 Years)]

   ORR as assessed by the Investigator

2. Best Overall Response (BOR): Percentage of Participants with CR, PR, Stable Disease (SD), or Progressive Disease (PD) [Randomization to Date of Objective Disease Progression (Estimated as up to 4 Years)]

   BOR as assessed by the Investigator and IRC

3. Duration of Response (DOR) [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)]

   DOR as assessed by the Investigator and IRC

4. Progression Free Survival (PFS) [Randomization to Objective Progression or Death Due to Any Cause (Estimated as up to 4 Years]

   PFS

5. Overall Survival (OS) [Randomization to Death from Any Cause (Estimated as up to 4 Years)]

   OS

6. 7. Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve from Time Zero to last (AUC[0-t) of LOXO-305 [Cycle 1 Day 1 Predose through Cycle 4 Day 1 Postdose (Cycle = 28 Days)]

   PK: AUC(0-t) of LOXO-305

7. PK: Maximum Concentration (Cmax) of LOXO-305 [Cycle 1 Day 1 Predose through Cycle 4 Day 1 Postdose (Cycle = 28 Days)]

   PK: Cmax of LOXO-305

8. 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) [Baseline through End of Treatment (Estimated as up to 3 Years)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yijishan Hospital, Wannan Medical College	Wuhu	Anhui	China	241000
2	Beijing Cancer hospital	Beijing	Beijing	China	100142
3	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510060
4	Southern Medical University Nanfang Hospital	Guangzhou	Guangdong	China	510515
5	Hainan Province People's Hospital	Haikou	Hainan	China	570100
6	Affiliated Hospital of Hebei University	Baoding	Hebei	China	071030
7	Xingtai People's Hospital	Xingtai	Hebei	China	054031
8	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang	China	150081
9	The First Affiliated Hospital of Henan University of Science &Technology	Luoyang	Henan	China	471003
10	Henan Cancer Hospital	Zhengzhou	Henan	China	450008
11	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei	China	430022
12	Xiangya Hospital Central South University	Changsha	Hunan	China	410008
13	Hunan Cancer Hospital	Changsha	Hunan	China	410013
14	Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu	China	210000
15	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China	215006
16	The First Hospital of Jilin University	Changchun	Jilin	China	130021
17	Xi'an International Medical Center Hospital	Xi'an	Shaanxi	China	710126
18	Shanghai East Hospital	Shanghai	Shanghai	China	200120
19	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin	China
20	Affiliated Tumor Hospital of Xinjiang Medical University	Urumqi	Xinjiang	China	830002
21	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022
22	Sichuan Cancer Hospital	Chengdu		China	610041
23	Blood Institute of the Chinese Academy of Medical science	Tianjin		China	300020

Sponsors and Collaborators

• Eli Lilly and Company
• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04849416
• Other Study ID Numbers: 17746; J2N-MC-JZNJ
• First Posted: Apr 19, 2021
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 4, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Leukemia, Lymphoid; Lymphoma, Large B-Cell, Diffuse; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, B-Cell, Marginal Zone

Study Results

No Results Posted as of Aug 19, 2022