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CLL/SLLPhase 1/2NCT03493217

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

A Phase 1/2 study testing ICP-022 in people with CLL/SLL, run by Beijing InnoCare Pharma Tech Co., Ltd. at 25 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
CLL/SLL
What is being tested?
ICP-022
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
25 sitesChina
Study dates
17 Apr 2018to 31 Dec 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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:
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  • 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.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Jilin Cancer Hospital

    Changchun, Jilin, 130012

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • West China Hospital,Sichuan University

    Chengdu, Sichuan, 610041

  • The second affiliated hospital of dalian medical university

    Dalian, Liaoning, 116044

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052

  • Second affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang

  • Anhui Province Cancer Hospital

    Hefei, Anhui, 230009

  • Qilu Hosptial of Shandong University

    Jinan, Shandong, 250012

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Xinhua hospital affiliated to medical college of Shanghai jiao tong university

    Shanghai, Shanghai Municipality, 200025

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • The Chinese Academy of Medical Sciences Hematology Hospital

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022

  • Tongji Hospital

    Wuhan, Hubei, 430030

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • Henan Tumor Hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

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)

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

Read the 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.

Conditions
CLL/SLL
Being tested
ICP-022

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICP-022Drug

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

Study groups in NCT03493217
Study groupRoleWhat they receive
ICP-022ExperimentalTwo 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.
Receives: Drug: ICP-022

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 3 years

Secondary outcomes (6)

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

    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

    Measured: Up to 3 years

  2. TTR

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

    Measured: Up to 3 years

  3. TTP

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

    Measured: Up to 3 years

  4. PFS

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

    Measured: Up to 3 years

  5. DOR

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

    Measured: Up to 3 years

  6. OS

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

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2018
  2. Study start17 Apr 2018
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Dec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03493217
Sponsor's protocol ID
ICP-CL-00103
Status last verified
Jun 2022
First submitted
19 Mar 2018
Last updated
6 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing ICP-022 in people with CLL/SLL, run by Beijing InnoCare Pharma Tech Co., Ltd. at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1.Objective response rate (ORR) (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03493217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.

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