BGB-3111 : A Phase IA, Open Label, Multiple Dose, Dose Escalation Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects with Indolent B-Cell Lymphoid Malignancies

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

18 - 75Age 18 - 75

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaChronic Lymphocytic Leukaemia, Diffuse Large Cell Lymphoma, Follicular Lymphoma, B-Cell Non Hodgkin Lymphoma

Trial Overview Read MoreRead more

This phase I trial is investigating a new drug (BGB3111) for the treatment of B-Cell Lymphomas.
 

This trial is treating patients with B-Cell Non Hodgkin Lymphoma.

This is a systemic therapy trial.

You may be excluded from this trial if:

  • You have had certain treatments, surgical procedures or drugs.
  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.

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 Phase IA, Open Label, Multiple Dose, Dose Escalation Study to Investigate the Safety and Pharmacokinetics of the BTK Inhibitor BGB-3111 in Subjects with Indolent B-Cell Lymphoid Malignancies

Commercial Sponsor

BeiGene Australia Pty Ltd

Summary

This is a multicentre, Phase I, open-label, multiple-dose, dose escalation, first-in-human study. It is to be conducted in two sequential parts: dose escalation, followed by safety and schedule expansion. Part 1: Dose Escalation - this will follow a classic “3+3” dose escalation schedule. The starting dose will be 40mg/day (once daily). The period for dose limiting toxicity (DLT) assessment is 21 days from first dose of BGB3111. Evaluation of a cohort of at least three (3) subjects completing DLT assessment at any given dose level is required prior to determining the next dose level and dose regimen for the subsequent cohort. Pharmacodynamic effect of BGB3111 on BTK inhibition will be studied in peripheral blood mononuclear cells (PBMCs) and in bone marrow and lymph nodes if available. The continuous safety evaluation will be performed by the sponsor, the coordinating investigator, and investigators. A Safety Monitoring Committee (SMC) will be established for the determination of dose levels to be administered and dose regimen during dose escalation, and will utilize the data available from the previous dose levels. In the event that a Maximal Tolerated Dose (MTD) is not identified due to paucity of DLTs, the dosing regimen used in the safety and schedule expansion will be based on pharmacodynamic studies of BTK inhibition in PBMCs, bone marrows and lymph nodes (if available). Part 2: Safety and Schedule Expansion – this will evaluate the MTD (or anticipated Phase 2 dose, if no MTD defined) in a further 20 subjects. Subjects will be assigned to the MTD on a once daily schedule, or 50% MTD given twice a day, by alternate allocation. Patients in this part will undergo a lymph node and bone marrow biopsy at screening stage and before their day 3 dose – i.e. either 10-14 or 22-26 hours post dose, depending on assigned schedule for pharmacodynamic studies of BTK inhibition in lymph nodes and bone marrow in addition to that in PBMCs. This study will be considered complete once all patients have either manifested disease progression, ceased BGB3111 due to intolerance, or completed a total of 12 months of BGB3111. Patients in both parts of the study continuing to show clinical benefit at 12 months will be allowed to continue BGB3111 until disease progression or intolerance, on an extension study.

Recruiting Hospitals Read MoreRead more

Monash Medical Centre Haematology Research Unit
Clayton
Ms Anita Cummins
anita.cummins@southernhealth.org.au
03 9594 4044

PCCTU (Parkville cancer clinical trials unit) *
Parkville
Ms Marian Lieschke
marian.lieschke@petermac.org
03 8559 7140

Not Recruiting Hospitals Read MoreRead more

Closed

Austin Hospital
Heidelberg
Ms Samantha Chakar
samantha.chakar@austin.org.au
03 9496 3088