A Study to Evaluate ICP-022 in Patients With R/R Marginal Zone Lymphoma (MZL)

NCT03797456 | Completed Phase 2

• 1 other identifier: ICP-CL-00104
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 32

Brief Summary

The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022. Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with R/R MZL will be evaluated in approximately 110 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.

Conditions

MZL

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  The efficacy measured by overall response rate (ORR) in Part II according to the 2014 International Working Group NHL

  Up to 3 years

Secondary Outcomes (9)

• Occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria in Part I

  Up to 3 years

• Progressioin free survival (PFS)

  Up to 3 years

• Duration of Response (DR)

  Up to 3 years

• Overall survival (OS)

  Up to 3 years

• Area under the concentration time curve up to the time "t" (AUC(0-t))

  up to 4 weeks

Study Arms (1)

ICP-022

EXPERIMENTAL

Drug: ICP-022

Interventions

ICP-022 DRUG

ICP-022 (tablets, 50 mg) is given orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.

ICP-022

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between 18 and 75 years old
• Histologically confirmed marginal zone lymphoma (MZL), and at least one measurable tumor of greater than 1.5 centimeter outside of the spleen
• Subjects with refractory or relapsed MZL who has received at least 1 but no more than 4 prior therapies for MZL
• ECOG performance status of 0-2
• Documented failure to achieve at least partial response (PR) or documented disease progression after response to the most recent treatment regimen
• Subjects who have indications for treatment (threatened end-organ function, bulky disease \>5cm, symptoms, steady progression, wish to treat)
• Subjects meet the following laboratory parameters:
• Absolute neutrophil count (ANC) ≥ 1.5×109/L Platelet count ≥ 75×109/L, independent of growth factor support within 7 days of the first dose with study drug, Hemoglobin ≥ 75 g/L; ANC ≥ 1.0×109/L, Platelet count ≥ 50×109/L, Hemoglobin ≥ 50 g/L; if bone marrow involvement
• Total bilirubin ≤ 1.5× ULN; AST or ALT ≤ 2× ULN; Creatinine ≤ 1.5× ULN; Amylase ≤ ULN and Lipase ≤ ULN
• International normalized ratio (INR) ≤ 1.5 ULN
• Life expectancy ≥ 3 months
• Able to provide signed written informed consent

You may not qualify if:

• History of other active malignancies within 5 years of study entry, unless cured without evidence of relapse or metastasis
• Current or history of lymphoma involved central nervous system
• Prior corticosteroids (at dosages equivalent to prednisone \> 20 mg/day) given with anti-neoplastic intent within 7 days, prior chemotherapy, targeted therapy, radiation therapy, or antibody-based therapies or anti-cancer TCM within 4 weeks of the start of study drug
• Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (except for alopecia)
• Current clinically significant cardiovascular disease including:
• Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) \< 50%
• Primary cardiomyopathy
• Clinical significant QTc prolong history or QTc\>470ms (female) QTc\>450ms (male)
• Uncontrolled hypertension
• Known active bleeding within 2 months of screening or currently taking anticoagulant/antiplatelet drugs
• Urine protein ≥ 2+ and quantitation ≥ 2g/24hours
• History of deep vein thrombosis or pulmonary embolism
• Toxicity must be recovered to ≤ Grade 1 from prior anti-cancer therapy
• Disease significantly affecting gastrointestinal function such as dysphagia, chronic diarrhea, intestinal obstruction, or resection of the stomach
• Prior organ or hematopoietic stem cell transplant

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (32)

Anhui Provincial Hospital

Hefei, Anhui, 230002, China

Location

Anhui Cancer Hospital

Hefei, Anhui, 230031, China

Location

Chinese People's Liberation Army General Hospital Fifth Medical Center

Beijing, Beijing Municipality, 100039, China

Location

Peking university People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 102206, China

Location

Union Hospital Affiliated to Fujian Medical University

Fuzhou, Fujian, 350001, China

Location

The Second Hospital of Lanzhou University

Lanzhou, Gansu, 730030, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510062, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 519041, China

Location

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550004, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, 150081, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210029, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Jiangxi Cancer Hospital

Nanchang, Jiangxi, 330029, China

Location

First Hospital of Jilin University

Changchun, Jilin, 130061, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250063, China

Location

Cancer Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

Hematology Hospital, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

Location

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Zhejiang University Medical School affiliated to the first Hospital

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Study Officials

• Jun Zhu, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 9, 2019
• Study Start: April 1, 2019
• Primary Completion: December 27, 2023
• Study Completion: February 6, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (32)