A Study to Evaluate ICP-022 in Patients With R/R Mantle Cell Lymphoma (MCL)

NCT03494179 | Unknown Phase 1

• 1 other identifier: ICP-CL-00102
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 31

Brief Summary

The phase I/II clinical study is to investigate the safety, tolerability and pharmacokinetics/ pharmacodynamics of ICP-022.

Conditions

Mantle Cell Lymphoma

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 (10)

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

  Up to 3 years

• time to progression (TTP)

  Up to 3 years

• progression free survival (PFS)

  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 (2)

High Dose of ICP-022

EXPERIMENTAL

Two regimens of ICP-022 (High dose QD and low dose BID) are designed for study Part I to determine RP2D which will be used in Part II to further evaluate the preliminary anti-tumor effects of ICP-022 in Chinese subjects with R/R MCL.

Drug: ICP-022

Low Dose of ICP-022

EXPERIMENTAL

Two regimens of ICP-022 (High dose QD and low dose BID) are designed for study Part I to determine RP2D which will be used in Part II to further evaluate the preliminary anti-tumor effects of ICP-022 in Chinese subjects with R/R MCL.

Drug: ICP-022

Interventions

ICP-022 DRUG

The drug product is a white, round, uncoated tablet.

High Dose of ICP-022; Low Dose of 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 mantle cell lymphoma (MCL), with either t(11;14) by cytogenetics and/or cyclin D1 overexpression by immunohistochemistry (IHC)
• Subjects with refractory or relapsed mantle cell lymphoma who has received at least 1 but no more than 4 prior therapies for MCL
• At least one measurable tumor of greater than 1.5 centimeter in long axis by contrast-enhanced CT/MRI
• 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 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 ≥ 80 g/L; ANC ≥ 1.0×109/L, Platelet count ≥ 50×109/L if bone marrow involvement
• Total bilirubin ≤ 2× ULN; AST or ALT ≤ 2.5 ULN; Creatinine clearance ≥ 30ml/min; Amylase ≤ ULN and Lipase ≤ ULN
• International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (APTT) ≤ 1.5 ULN
• Life expectancy ≥ 4 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
• 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
• Disease significantly affecting gastrointestinal function such as dysphagia, chronic diarrhea, intestinal obstruction, or resection of the stomach
• Allogeneic stem cell transplant within 6 months prior to first dose of study drug or related active infection
• Major surgery within 6 weeks of screening, except for diagnostic test or vascular access setup

Sponsors & Collaborators

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

Study Sites (31)

Anhui Province Cancer Hospital

Hefei, Anhui, 230009, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 102206, China

Location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Guangzhou First People's Hospital

Guangzhou, Guangdong, 510180, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, 450003, China

Location

Henan Tumor Hospital

Zhengzhou, Henan, 450008, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, 210029, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130012, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The First Hospital of China Medical University

Shenyang, Liaojing, 110001, China

Location

The Second Hospital of Dalian Medical University

Dalian, Liaoning, 116044, China

Location

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110042, China

Location

Qilu Hosptial of Shandong University

Jinan, Shandong, 250012, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266071, China

Location

Zhongshan Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Xin Hua Hospital Affiated to Shanghai Jiao Tong University School of Medicin

Shanghai, Shanghai Municipality, 200092, China

Location

West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The First Affiliated Hospital of Zhengjiang University

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location

Related Publications (1)

• Deng LJ, Zhou KS, Liu LH, Zhang MZ, Li ZM, Ji CY, Xu W, Liu T, Xu B, Wang X, Gao SJ, Zhang HL, Hu Y, Li Y, Cheng Y, Yang HY, Cao JN, Zhu ZM, Hu JD, Zhang W, Jing HM, Ding KY, Zhang XY, Zhao RB, Zhang B, Tian YM, Song YP, Song YQ, Zhu J. Orelabrutinib for the treatment of relapsed or refractory MCL: a phase 1/2, open-label, multicenter, single-arm study. Blood Adv. 2023 Aug 22;7(16):4349-4357. doi: 10.1182/bloodadvances.2022009168.

  PMID: 37078706 DERIVED

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jun Zhu, PhD

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 11, 2018
• Study Start: April 2, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-05

Locations

CN (31)