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

October 10, 2022 updated by: Beijing InnoCare Pharma Tech Co., Ltd.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 102206
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)
  • Subjects meet the following laboratory parameters:

    1. 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
    2. Total bilirubin ≤ 1.5× ULN; AST or ALT ≤ 2× ULN; Creatinine ≤ 1.5× ULN; Amylase ≤ ULN and Lipase ≤ ULN
    3. International normalized ratio (INR) ≤ 1.5 ULN
  • Life expectancy ≥ 3 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
  • 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%
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ICP-022
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to 3 years
The efficacy measured by overall response rate (ORR) in Part II according to the 2014 International Working Group NHL
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria in Part I
Time Frame: Up to 3 years
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
Up to 3 years
Area under the concentration time curve up to the time "t" (AUC(0-t))
Time Frame: up to 4 weeks
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.
up to 4 weeks
Maximum plasma drug concentrations (Cmax)
Time Frame: up to 4 weeks
Individual plasma concentrations of ICP-022 will be measured and Cmax will be calculated with noncompartmental analysis using WinNonlin.
up to 4 weeks
Time of maximum plasma drug concentrations (Tmax)
Time Frame: up to 4 weeks
Time of maximum plasma drug concentrations (Tmax) of ICP-022 will be recorded.
up to 4 weeks
Apparent half-life for designated elimination phases (t½)
Time Frame: up to 4 weeks
Apparent half-life for designated elimination phases (t½) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.
up to 4 weeks
Area under the concentration time curve up to the last data point above LOQ (AUC(last))
Time Frame: up to 4 weeks
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.
up to 4 weeks
Progressioin free survival (PFS)
Time Frame: Up to 3 years
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.
Up to 3 years
Duration of Response (DR)
Time Frame: Up to 3 years
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.
Up to 3 years
Overall survival (OS)
Time Frame: Up to 3 years
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.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 7, 2019

First Posted (ACTUAL)

January 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 12, 2022

Last Update Submitted That Met QC Criteria

October 10, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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