Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

BGB-3111-113 : A Drug-Drug Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-Cell Malignancies

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaB-Cell Non Hodgkin Lymphoma,Chronic Lymphocytic Leukaemia,Diffuse Large Cell Lymphoma,Follicular Lymphoma,Mantle Cell Lymphoma

Trial Overview Read MoreRead more

This phase I trial is trying to understand how the body reacts to a targeted therapy drug (zanubrutinib) with administered in combination with enzyme inhibitors (cytochrome P450 A) in people with B-Cell malignancies.
 

This trial is treating patients with B-cell malignancies (lymphoma).

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Drug-Drug Interaction Study of Zanubrutinib With Moderate and Strong CYP3A Inhibitors in Patients With B-Cell Malignancies

Commercial Sponsor

BeiGene Australia Pty Ltd

Summary

This is a randomised trial with two experimental arms. In Experimental Arm one, participants will receive zanzubrutinib in combination with moderate Cytochrome P450 A (CYP3A) inhibitors. Cycle 1 (28 days): Zanubrutinib 80 mg twice daily (BID) + fluconazole (days 4 - 10), zanubrutinib 320 mg once daily (QD) (days 13 - 19), zanubrutinib 80 mg BID + diltiazem (days 20 - 26) Cycles 2 - 6 (28 days each): zanubrutinib 160 mg BID or 320 mg QD. Zanubrutinib: 80 mg capsules administered at a dose and frequency as specified in the treatment arm. Fluconazole: 400 mg administered as 2 x 200 mg capsules once daily (QD). Diltiazem:180 mg capsule administered once daily (QD) In Experimental Arm two, participants will receive zanubrutinib + strong CYP3A. Cycle 1 (28 days): Zanubrutinib 80 mg QD + voriconazole (days 4 - 10), zanubrutinib 320 mg QD (days 13 - 19), zanubrutinib 80 mg QD + clarithromycin (days 20 - 26) Cycles 2 - 6 (28 days each): zanubrutinib 160 mg BID or 320 mg QD. Zanubrutinib: 80 mg capsules administered at a dose and frequency as specified in the treatment arm. Voriconazole: 200 mg capsules administered twice daily (BID). Clarithromycin: 250 mg capsules administered twice daily (BID)

Recruiting Hospitals Read MoreRead more

Monash Health Haematology Research Unit
Clayton
Ms Anita Cummins
anita.cummins@monashhealth.org
03 9594 4044

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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