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RecruitingLast updated:15 August 2023

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

Clinical summary

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)

Age

People18+

Phase

I

Trial Acronym

BGB-3111-113

More information

Trial Identifiers

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Commercial Sponsor

BeiGene Australia Pty Ltd

Scientific Title

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

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.

Exclusion

  • 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.
Message

Clinical trials have complex eligibility criteria.

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