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Assessing an Oral Bruton Tyrosine Kinase Inhibitor, DZD9008 in Patients Who Have Non-Hodgkin B-cell Lymphoma (WU-KONG3)

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ClinicalTrials.gov Identifier: NCT04148742
Recruitment Status : Suspended (Clinical development strategy adjustment, non-safety reason)
First Posted : November 1, 2019
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Dizal Pharmaceuticals

Brief Summary:
This study will treat patients with non-Hodgkin B-cell lymphoma who have relapsed from, refractory or intolerant to prior therapy. This study will help understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's B-cell Lymphoma Drug: DZD9008 Phase 1 Phase 2

Detailed Description:
A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients with Non-Hodgkin B-cell Lymphoma. This study includes dose escalation (Part A) and dose expansion (Part B).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Non-Hodgkin B-cell Lymphoma
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: daily dose of DZD9008
daily dose of DZD9008
Drug: DZD9008
Daily dose of DZD9008, except for cycle 0 of Part A, in which a single dose of DZD9008 is administrated. Starting dose of DZD9008 is 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD9008.




Primary Outcome Measures :
  1. Part A: Incidence of Treatment-Emergent Adverse Events [ Time Frame: Through study completion, an average of 1.5 years ]
    Incidence of Treatment-Emergent Adverse Events as Assessed by CTCAE v5.0

  2. Part B: objective response rate (ORR) [ Time Frame: Through study completion, an average of 1.5 years ]

Secondary Outcome Measures :
  1. Maximum Plasma DZD9008 concentration [ Time Frame: up to 16 weeks ]
  2. Plasma DZD9008 concentration- Area Under the Curve [ Time Frame: up to 16 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Aged at least 18 years old.
  • Patients must be willing and able to participate in all required evaluations and procedures.
  • Patients must be able to provide a signed written informed consent.
  • With documented histologically confirmed diagnosis of CLL/SLL, MCL or MZL and have least 1 measurable site of disease. Subjects must have relapsed, or are refractory or intolerant to >= 2 lines of prior therapy, and without preferred alternative treatment as judged by investigator. For Part B, subjects should be either BTK inhibitor treatment naive or intolerant to prior BTK inhibitor within 6 months on treatment.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Predicted life expectancy ≥ 12 weeks.
  • Adequate organ system functions.

Exclusion criteria:

  • Prior malignancy requires active treatment within 2 to 3 years.
  • A life-threatening illness, medical condition or organ system dysfunction.
  • Radiotherapy with a limited field of radiation for palliation within 1 week of the screening.
  • Major surgery within 4 weeks before screening.
  • Prior treatment with any onco-immunotherapy within 4 weeks before screening.
  • Subjects require immediate cytoreduction.
  • Any history of Richter's transformation.
  • Central nervous system (CNS) involvement unless previous treated and asymptomatic.
  • Requires anticoagulation therapy with Warfarin, heparin.
  • Known history of human immunodeficiency virus (HIV); Positive Hepatitis B surface antigen (HbsAg) or positive HCV antibodies; any other uncontrolled active systemic infection.
  • Any of the following cardiac criteria: (1) mean resting corrected QT interval (QTcF) > 470 msec obtained from 3 electrocardiograms (ECGs). (2) prior history of atrial fibrillation. (3) any factors that increase the risk of QTcF prolongation, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age in first degree relatives or any concomitant medication known to prolong the QT interval
  • History of stroke or intracranial haemorrhage.
  • Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
  • Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection.
  • History of hypersensitivity.
  • Receiving (or unable to stop using) medications or herbal supplements known to be potent inhibitors or inducers of CYP3A.
  • Grapefruit, grapefruit juice, and orange marmalade (made with Seville oranges) should be excluded.
  • Women who are pregnant or breast feeding
  • Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements
  • Previous allogenic bone marrow transplant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04148742


Locations
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China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Nanjing, China
Jiangsu Province Hospital - Haematology
Nanjing, China
Sponsors and Collaborators
Dizal Pharmaceuticals
Investigators
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Principal Investigator: Jianyong Li The First Affiliated Hospital with Nanjing Medical University
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Responsible Party: Dizal Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04148742    
Other Study ID Numbers: DZ2019B0001
First Posted: November 1, 2019    Key Record Dates
Last Update Posted: June 11, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin