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CompletedLast updated: 5 February 2024

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)

Conditions

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

Cancer

Blood Cancers Haematological

Age

People18+

Phase

I

Trial Acronym

BGB-3111-113

More information

Trial Identifiers

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Trial 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

  1. Histologically or cytologically confirmed CLL/SLL, MCL, WM, or MZL.
  2. Relapsed or refractory disease after at least 1 prior line of systemic therapy. Participants with MZL are required to have failed an anti-CD20 monoclonal antibody-containing chemotherapy regimen.
  3. Baseline Eastern Cooperative Oncology Group performance status of 0 to 1.
  4. Meet protocol guidelines for adequate bone marrow, kidney, liver, and cardiac function.

Exclusion

  1. Requirement of chronic treatment with strong and moderate CYP3A inhibitors or inducers or with drugs that are not allowed to be used in combination with diltiazem, clarithromycin, fluconazole, or voriconazole.
  2. History of stroke or intracranial hemorrhage (within 6 months of treatment start).
  3. Known hypersensitivity or contraindication to zanubrutinib, diltiazem, clarithromycin, fluconazole, or voriconazole.
  4. Prior exposure to zanubrutinib or other Bruton tyrosine kinase inhibitor
  5. Unable to swallow capsules or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • 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.

Exclusion

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

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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