A Phase I study of BGB-3111 in B-Cell Lymphoid Malignancies

• Research type

  Research Study

• Full title

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

• IRAS ID

  214078

• Contact name

  Michael Dudley

• Contact email

  michael.dudley@parexel.com

• Sponsor organisation

  BeiGene Aus Pty Ltd

• Eudract number

  2016-003364-39

• Clinicaltrials.gov Identifier

  NCT02343120

• Duration of Study in the UK

  1 years, 5 months, 1 days

• Research summary

  Research Summary
  B-Cell lymphoid malignancy is the term used to describe a group of blood cancers that affect B cells (a type of white blood cell). White blood cells are the cells that make up the immune system. There are many different types of B-Cell lymphoid malignancy and they can be described as either low or high grade. Low grade lymphomas are slow growing while high grade are aggressive (which means they develop and worsen fast). Slow growing lymphomas can generally be kept under control (known as in remission) for many years with the right treatment but are rarely cured. Meanwhile, aggressive lymphomas usually require intensive treatments but there can be good chance of a permanent cure with the right treatment.
  Current treatments vary depending on the type of lymphoma and the grade. Aggressive lymphomas, when identified early, have a cure rate of 70-90%.
  This study is investigating a new drug (called BGB-3111) as a potential treatment for B-cell lymphoid malignancies. BGB-3111 works by inhibiting (blocking the action of) a protein called Bruton’s tyrosine kinase (BTK) which plays a role in the development of B cells. In this study, the developers of BGB-3111 want to see how safe the drug is and the effect that the body has on the drug when it is used in patients with B-cell lymphoid malignancies. This is a phase 1 study which means it is the first time the drug has been used to treat patients with this disease.
  The study is taking place in the UK as well as elsewhere in Europe and in Australia, New Zealand, the USA, and South Korea. The Sponsor (the developers of the drug who are organising this research) is BeiGene Australia Ltd. It is expected around 405 participants will be involved in the study in total.

  Summary of Results
  A plain language lay summary of clinical trial results for BGB-3111-AU-003 is available at: https://eur03.safelinks.protection.outlook.com/?url=http%3A%2F%2Furl6570.hra.nhs.uk%2Fls%2Fclick%3Fupn%3DXv3JSvJ-2B3M71ppf7N9agbbzlYJ0Sdw9UMS3jGCBqtK515lmOeNHeKGkXJk0g8dp-2F-2BxesAKIrzkdOgV2dF7O5Lotw7DD1aovus-2Fw3ig71Fo4-3DlD45_E1aO2-2BZlVOSJJV-2FajQqskegTd6IRomHYTi-2Fbt8SH3YLRL1vNEXsQhqAtv2Cmub2HjKo87wuNs8ceX-2BKeKa9RGf58kYlvC4j-2Bz1TZRwGVIup74tjKw9y9jj4i3sc2PNeOUc0Ilu9PmB2cK4H9vZQRSsd80T1kLiEJCNvH3vmPw2gwPZTk02nBT0-2Batxvdb0Uew2qNWizXS-2FZFKmI5bIs0-2Fg-3D-3D&data=04%7C01%7Capprovals%40hra.nhs.uk%7C49c44652193a4e8d0a3e08da129c70e0%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C637842760359097043%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000&sdata=UOWqElXhTm0AQl5Qw%2FRG4V%2FN%2F37wQf%2FT0tNSjPSFfOQ%3D&reserved=0

• REC name

  North East - York Research Ethics Committee

• REC reference

  17/NE/0109

• Date of REC Opinion

  8 Aug 2017

• REC opinion

  Further Information Favourable Opinion