A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia)
- Conditions
- Leukemia, LymphoidLymphoma, Non-HodgkinLymphoma, Mantle-CellLymphoma, Large B-Cell, DiffuseLymphoma, B-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell
- Interventions
- Registration Number
- NCT04849416
- Lead Sponsor
- Eli Lilly and Company
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 87
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LOXO-305 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.
- Primary Outcome Measures
Name Time Method Primary Analysis Set (PAS): Overall Response Rate (ORR) Assessed by Independent Review Committee Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks) ORR was assessed by an Independent Review Committee (IRC). It was estimated based on the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). Two-sided 95% CI was calculated using the exact binomial distribution. PAS consisted of participants with Central histologically confirmed non-blastoid MCL, with no CNS metastases and treated with prior chemoimmunotherapy and BTK inhibitor-containing regimen, measurable disease at baseline as assessed using Lugano criteria, and have received at least 1 dose of study drug.
- Secondary Outcome Measures
Name Time Method PAS ORR: ORR Assessed by Investigator Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks) ORR was assessed by the Investigator. It was estimated based on the percentage of participants with BOR of CR or PR. Two-sided 95% CI was calculated using the exact binomial distribution.
PAS Best Overall Response (BOR): Percentage of Participants With CR, PR, Stable Disease (SD), Progressive Disease (PD) or Not Evaluable (NE) Date of First Dose to Date of Disease Progression or Subsequent Anti-cancer Therapy (up to 100 Weeks) BOR was assessed by the IRC and Investigator. Best overall assessment categories include (in descending order of extent of response): CR, PR, SD, PD, and NE. Two-sided 95% CI was calculated using the exact binomial distribution.
PAS: Duration of Response (DOR) Date of CR or PR to Date of Disease Progression or Death Due to Any Cause (Up to 100 Weeks) DOR was assessed by the Investigator and IRC. DOR is defined as the number of months from the date of the first documented response to the date of PD or death, whichever occurs earlier. Participants who are alive and without documented PD as of data analysis cutoff date will be censored.
PAS: Progression Free Survival (PFS) Date of First Dose to Progressive Disease or Death from Any Cause (Up to 100 weeks) PFS was assessed by the IRC and Investigator. PFS is defined as the number of months from the date of the first dose of study drug to the earlier of documented PD or death due to any cause. Participants who are alive and without documented PD as of data analysis cutoff date were censored.
PK: Maximum Concentration (Cmax) of LOXO-305 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. PK: Cmax of LOXO-305
PAS: Overall Survival (OS) Date of First Dose to Date of Death from Any Cause (Up to 100 weeks) OS is defined as the number of months elapsed between the date of the first dose of study drug and the date of death from any cause. Participants who are alive or lost to follow-up as of the data cutoff date will be censored.
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Time Zero to Last Quantifiable Concentration(AUC[0-tlast] of LOXO-305 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. PK: AUC\[0-tlast\] of LOXO-305
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) Baseline, 7 Days After Treatment Discontinuation (Up To 100 Weeks) EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures global health status, 5 functional domains (physical, role, cognitive, emotional, and social) and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation, diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, scores range from 0 to 100 with higher scores representing a better level of functioning. For symptoms scales, scores range from 0 to 100 with higher scores representing a greater degree of symptoms.
Trial Locations
- Locations (22)
Beijing Cancer hospital
🇨🇳Beijing, Beijing, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
Xingtai People's Hospital
🇨🇳Xingtai, Hebei, 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 Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Wannan Medical College Yijishan Hospital
🇨🇳Wuhu, Anhui, China
Tianjin Medical University Cancer Institute and Hospital
🇨🇳Tianjin, Tianjin, China
Southern Medical University Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
Xi'an International Medical Center Hospital
🇨🇳Xi'an, Shaanxi, China
Xinjiang Medical University Cancer Hospital - Urumqi
🇨🇳Urumqi, Xinjiang, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Harbin Medical University Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Henan University of Science &Technology
🇨🇳Luoyang Shi, Henan, China
Sichuan Cancer Hospital
🇨🇳Chengdu, Sichuan, China
Institute of hematology&blood disease hospital
🇨🇳Tianjin, Tianjin, China
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China
Affiliated Hospital of Hebei University
🇨🇳Baoding, Hebei, China
The First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Zhejiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
Shanghai East Hospital
🇨🇳Shanghai, China