A Study to Evaluate ICP-022 in Patients With CLL/ SLL

NCT03493217 | Unknown Phase 1

• 1 other identifier: ICP-CL-00103
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 25

Brief Summary

The phase I/II clinical study is to investigate the safety, tolerability and efficacy of ICP-022 in R/R CLL/SLL patients.

Conditions

CLL/SLL

Outcome Measures

Primary Outcomes (1)

• 1.Objective response rate (ORR)

  The efficacy measured by overall response rate (ORR) in Part II. Efficacy was evaluated by researchers according to IWCLL2008standard and update standard (Hallek, 2012), which was defined as complete remission (CR) of CLLsubjects, complete remission with incomplete bone marrow recovery (CRi), or partial remission (PR),including nodular partial remission (nPR) and partial remission with lymphocytosis (pr-l).SLL subjectsachieved complete response (CR) or partial response (PR).

  Up to 3 years

Secondary Outcomes (6)

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

  Up to 3 years

• TTR

  Up to 3 years

• TTP

  Up to 3 years

• PFS

  Up to 3 years

• DOR

  Up to 3 years

Study Arms (1)

ICP-022

EXPERIMENTAL

Two regimens of ICP-022 (High and low dose QD) are designed for study Part I to determine RP2D. The RP2D determined will be used in Part II to further evaluate the preliminary efficacy of ICP-022 in Chinese subjects with R/R CLL/SLL.

Drug: ICP-022

Interventions

ICP-022 DRUG

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

ICP-022

Eligibility Criteria

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

You may qualify if:

• Men and women with the age more than 18 years
• Subjects with confirmed diagnosis of CLL/SLL following IWCLL2008 criteria
• Refractory or relapsed CLL/SLL who have received at least one prior therapy
• At least two measurable tumors 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.There are medicalrecords confirming that the disease has not responded to the mostrecent treatment (complete and partial remission) or that thedisease has progressed after remission
• Subjects who meet the following laboratory parameters:
• Absolute neutrophil count (ANC) ≥ 0.75×109/L, Platelet count ≥ 50×109/L independent of growth factor support within 7 days of the first dose of study drug
• Total bilirubin ≤ 2× ULN (unless due to Gilbert's syndrome); AST or ALT ≤ 2.5 ULN; Creatinine ≤ 1.5 ULN; Amylase ≤ 1.5 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
• Any history of Richter's transformation
• 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 be recovered to ≤ Grade 1 from prior anti-cancer therapy (except 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
• Subjects with active bleeding within 2 months of study start 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
• Prior allogeneic stem cell transplant within 6 months prior to first dose of study drug or related active infection

Sponsors & Collaborators

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

Study Sites (25)

Anhui Province Cancer Hospital

Hefei, Anhui, 230009, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, 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

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 second affiliated hospital of dalian medical university

Dalian, Liaoning, 116044, China

Location

Qilu Hosptial of Shandong University

Jinan, Shandong, 250012, China

Location

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

Xinhua hospital affiliated to medical college of Shanghai jiao tong university

Shanghai, Shanghai Municipality, 200025, China

Location

West China Hospital,Sichuan University

Chengdu, Sichuan, 610041, China

Location

The Chinese Academy of Medical Sciences Hematology Hospital

Tianjin, Tianjin Municipality, 300020, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location

Second affiliated hospital of medical college of zhejiang university

Hangzhou, Zhejiang, China

Location

Study Officials

• Jianyong Li, MD

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 10, 2018
• Study Start: April 17, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (25)