PCYC-1145-LT Rollover study for ibrutinib
Research type
Research Study
Full title
Extended treatment protocol for subjects continuing to benefit from ibrutinib after completion of ibrutinib clinical trials.
IRAS ID
229453
Contact name
Graham Collins
Contact email
Sponsor organisation
Pharmacyclics Switzerland GmbH
Eudract number
2016-004356-30
Duration of Study in the UK
years, months, days
Research summary
This is a multicentre, open-label study that provides access to the medication ibrutinib to participants who have completed previous ibrutinib studies, are still benefiting from taking ibrutinib and have no access to ibrutinib to treat their underlying disease in their region.
Participants who are enrolled in the study will receive oral ibrutinib at the same dose and schedule that they were receiving in the previous parent ibrutinib study. Treatment with ibrutinib may continue as long as the participant gets benefit and until ibrutinib becomes commercially available.
The main purpose of the study is to provide ibrutinib to participants who are benefiting from it whilst continuing to monitor the effectiveness (how well the medication works) and safety of ibrutinib to participants (such as side-effects). Once enrolled on the study participants will be provided with enough ibrutinib to cover approximately 3 months of treatment or until their next treatment visit. Participants will be assessed by their Treating Doctor at the treatment visits to ask about side-effects, discuss further intake of ibrutinib and provide enough of the medication until their next treatment visit. 30 days after taking their last dose of ibrutinib or prior to the start of a different therapy for their underlying disease, participants will be assessed by their Treating Doctor again to check side-effects and collect unused ibrutinib medication. After this, participants may be contacted by their Treating Doctor if there are any unresolved side-effects.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
17/NE/0205
Date of REC Opinion
3 Jul 2017
REC opinion
Favourable Opinion