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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 28, 2019
First Posted Date  ICMJE November 1, 2019
Last Update Posted Date June 11, 2021
Estimated Study Start Date  ICMJE August 2021
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • 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
  • Part B: objective response rate (ORR) [ Time Frame: Through study completion, an average of 1.5 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2019)
  • Maximum Plasma DZD9008 concentration [ Time Frame: up to 16 weeks ]
  • Plasma DZD9008 concentration- Area Under the Curve [ Time Frame: up to 16 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing an Oral Bruton Tyrosine Kinase Inhibitor, DZD9008 in Patients Who Have Non-Hodgkin B-cell Lymphoma (WU-KONG3)
Official Title  ICMJE 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
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.
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Hodgkin's B-cell Lymphoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: daily dose of DZD9008
daily dose of DZD9008
Intervention: Drug: DZD9008
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: October 30, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date July 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04148742
Other Study ID Numbers  ICMJE DZ2019B0001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dizal Pharmaceuticals
Study Sponsor  ICMJE Dizal Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jianyong Li The First Affiliated Hospital with Nanjing Medical University
PRS Account Dizal Pharmaceuticals
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP