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

Sponsor
Beijing InnoCare Pharma Tech Co., Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03493217
Collaborator
(none)
100
Enrollment
25
Locations
1
Arm
56.5
Anticipated Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

Part I: Safety evaluation -2 regimens of ICP-022 (High and low dose QD) are designed for safety assessment. The recommended dose of phase II clinical study will be determined according to the Part I results.

Part II: Dose expansion -Anti-tumor effects of ICP-022 in Chinese patients with R/R CLL/SLL will be evaluated in approximately 80 subjects. The recommended Phase 2 dose will be used in the Part II.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-label Study to Evaluate the Safety and Efficacy of ICP-022 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
Actual Study Start Date :
Apr 17, 2018
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: ICP-022

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

Outcome Measures

Primary Outcome Measures

  1. 1.Objective response rate (ORR) [Up to 3 years]

    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).

Secondary Outcome Measures

  1. Occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria [Up to 3 years]

    The safety and tolerability of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria in Part I

  2. TTR [Up to 3 years]

    The efficacy measured by time to response (TTR) in Part II

  3. TTP [Up to 3 years]

    The efficacy measured by time to progression (TTP) in Part II

  4. PFS [Up to 3 years]

    The efficacy measured by progression free survival (PFS) in Part II

  5. DOR [Up to 3 years]

    The efficacy measured by duration of response (DOR) in Part II

  6. OS [Up to 3 years]

    The efficacy measured by overall survival (OS) in Part II

Eligibility Criteria

Criteria

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

  • 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

Exclusion Criteria:

  • 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

  • Prior organ or allogeneic hematopoietic stem cell transplant within 6 months prior to first dose of study drug

  • Major surgery within 6 weeks of screening, except for diagnostic test or vascular access setup

  • Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection

  • Any history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, severe lung function impairment

  • Prior exposure to a BTK inhibitor or PI3K, SYK, bcl-2 inhibitors

  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment

  • Any mental or cognitive disorder, unable to understand and comply with the requirements of the study

  • Drug abuser or alcoholics

  • Lactating or pregnant women, or women who will not agree to use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children

  • Requires treatment with moderate or strong cytochrome P450 family 3, subfamily A (CYP3A) inhibitors or strong CYP3A inducers.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anhui Province Cancer Hospital Hefei Anhui China 230009
2 Peking University People's Hospital Beijing Beijing China 100044
3 Peking University Third Hospital Beijing Beijing China 100191
4 Peking Union Medical College Hospital Beijing Beijing China 100730
5 Fujian Medical University Union Hospital Fuzhou Fujian China 350001
6 The First Affiliated Hospital of Xiamen University Xiamen Fujian China 361003
7 Sun Yat-sen University Cancer Center Guangzhou Guangdong China 510060
8 Guangzhou First People's Hospital Guangzhou Guangdong China 510180
9 The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei China 050011
10 Henan Provincial People's Hospital Zhengzhou Henan China 450003
11 Henan Tumor Hospital Zhengzhou Henan China 450008
12 Wuhan Union Hospital Wuhan Hubei China 430022
13 Tongji Hospital Wuhan Hubei China 430030
14 Jiangsu Province Hospital Nanjing Jiangsu China 210029
15 Jilin Cancer Hospital Chang Chun Jilin China 130012
16 The First Hospital of Jilin University Changchun Jilin China 130021
17 The second affiliated hospital of dalian medical university Dalian Liaoning China 116044
18 Qilu Hosptial of Shandong University Jinan Shandong China 250012
19 Shandong Provincial Hospital Jinan Shandong China 250021
20 Xinhua hospital affiliated to medical college of Shanghai jiao tong university Shanghai Shanghai China 200025
21 West China Hospital,Sichuan University Chengdu Sichuan China 610041
22 The Chinese Academy of Medical Sciences Hematology Hospital Tianjin Tianjin China 300020
23 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China 300060
24 The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou Zhejiang China 310052
25 Second affiliated hospital of medical college of zhejiang university Hangzhou Zhejiang China

Sponsors and Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

Investigators

  • Principal Investigator: Jianyong Li, MD, The First Affiliated Hospital with Nanjing Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Beijing InnoCare Pharma Tech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03493217
Other Study ID Numbers:
  • ICP-CL-00103
First Posted:
Apr 10, 2018
Last Update Posted:
Jul 6, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 6, 2022