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MZLPhase 2NCT03797456

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

A Phase 2 study testing ICP-022 in people with MZL, run by Beijing InnoCare Pharma Tech Co., Ltd. at 32 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
MZL
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
111 participants
Where
32 sitesChina
Study dates
1 Apr 2019to 6 Feb 2024
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

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
  • 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%
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  • 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
  • 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 or BCR pathway inhibitor (PI3K or Syk) and BCL-2 inhibitor
  • Suitable and ready for allogeneic stem cell transplant
  • Inability to comply with study procedures
  • Drug abuser or alcoholics
  • Lactating or pregnant women, or women who will not 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

32 sites in 1 country.

32 sites in 1 country

China32 sites

  • Chinese People's Liberation Army General Hospital Fifth Medical Center

    Beijing, Beijing Municipality, 100039

  • Peking university People's Hospital

    Beijing, Beijing Municipality, 100044

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 102206

  • First Hospital of Jilin University

    Changchun, Jilin, 130061

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044

  • Union Hospital Affiliated to Fujian Medical University

    Fuzhou, Fujian, 350001

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510062

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 519041

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550004

  • Zhejiang University Medical School affiliated to the first Hospital

    Hangzhou, Zhejiang, 310003

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Affiliated Cancer Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

  • Anhui Provincial Hospital

    Hefei, Anhui, 230002

  • Anhui Cancer Hospital

    Hefei, Anhui, 230031

  • Shandong Provincial Hospital

    Jinan, Shandong, 250021

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250063

  • The Second Hospital of Lanzhou University

    Lanzhou, Gansu, 730030

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

  • Jiangsu Provincial People's Hospital

    Nanjing, Jiangsu, 210029

  • Cancer Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Hematology Hospital, Chinese Academy of Medical Sciences

    Tianjin, Tianjin Municipality, 300020

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300060

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

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430030

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

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 Marginal Zone Lymphoma (MZL)

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
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

    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.

Study groups in NCT03797456
Study groupRoleWhat they receive
ICP-022ExperimentalNot described
Receives: Drug: ICP-022

What is being measured

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

  1. Overall Response Rate (ORR)

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

    Measured: Up to 3 years

Secondary outcomes (9)

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

    The safety 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. Progressioin free survival (PFS)

    Progression free survival (PFS) is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.

    Measured: Up to 3 years

  3. Duration of Response (DR)

    Duration of response as defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date.

    Measured: Up to 3 years

  4. Overall survival (OS)

    Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.

    Measured: Up to 3 years

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

    Area under the concentration time curve up to the time "t" (AUC(0-t)) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.

    Measured: up to 4 weeks

  6. Maximum plasma drug concentrations (Cmax)

    Individual plasma concentrations of ICP-022 will be measured and Cmax will be calculated with noncompartmental analysis using WinNonlin.

    Measured: up to 4 weeks

  7. Time of maximum plasma drug concentrations (Tmax)

    Time of maximum plasma drug concentrations (Tmax) of ICP-022 will be recorded.

    Measured: up to 4 weeks

  8. Apparent half-life for designated elimination phases (t½)

    Apparent half-life for designated elimination phases (t½) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.

    Measured: up to 4 weeks

  9. Area under the concentration time curve up to the last data point above LOQ (AUC(last))

    Area under the concentration time curve up to the last data point above LOQ (AUC(last)) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.

    Measured: up to 4 weeks

Timeline

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

  1. First posted9 Jan 2019
  2. Study start1 Apr 2019
  3. Primary completion27 Dec 2023
  4. Study completion6 Feb 2024

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03797456
Sponsor's protocol ID
ICP-CL-00104
Status last verified
Apr 2024
First submitted
7 Jan 2019
Last updated
18 Apr 2024
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 2 study testing ICP-022 in people with MZL, run by Beijing InnoCare Pharma Tech Co., Ltd. at 32 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 24 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: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall 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 NCT03797456.

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 18 Apr 2024.

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