BX44273 - Ipatasertib OLE study

• Research type

  Research Study

• Full title

  AN OPEN LABEL, MULTICENTER EXTENSION STUDY IN PATIENTS PREVIOUSLY ENROLLED IN A GENENTECH AND/OR F. HOFFMAN-LA ROCHE SPONSORED STUDY

• IRAS ID

  1007290

• Contact name

  Rachel Tedds

• Contact email

  welwyn.uk_ethics@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche Ltd

• Eudract number

  2022-003414-36

• Research summary

  This is an open-label, multicentre, extension study to provide continued treatment with Roche IMP(s) monotherapy or in combination with other agent(s) or comparator agent(s) for eligible patients with cancer who were previously enrolled and treated in a Genentech or Roche-sponsored study (the parent study) and who do not have access to the study treatment locally.

  This study will allow eligible participants to continue to receive parent study allocated treatment during and after roll-over from the parent-study. Patients without access to commercially available comparator treatment may enter this extension study.

  Participant data from this extension study can potentially be pooled with data from the parent study at a later date.

  The number of participants and sites is hard to predict as more parent studies may be added during the course of the study.

  The study is currently anticipated to end around the end of November 2033.

  The study is sponsored by F. Hoffmann- La Roche
  
  Research Summary; Version 1 dated 20-Apr-2023

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  23/LO/0467

• Date of REC Opinion

  22 Aug 2023

• REC opinion

  Further Information Favourable Opinion