Lintisinib Rollover Study
Research type
Research Study
Full title
A phase II open-label rollover study for subjects that have participated in an Astellas sponsored linsitinib trial
IRAS ID
144079
Contact name
Valentine Macaulay
Contact email
Sponsor organisation
Astellas Pharma Global Development, Inc.
Eudract number
2013-004076-34
Research summary
The study is to provide access to continued treatment for subjects who participated in other Astellas sponsored trials and for whom the investigator feels the subject may benefit from continued treatment.
Participants will receive the same treatment that they are currently receiving, either linsitinib, erlotinib, or paclitaxel and if they are receiving a combination of two of these medication, they will continue to receive the same combination.
In the UK, the parent study OSI-906-103 is conducted. Subjects who have participated in this study, upon meeting the inclusion criteria will be enrolled and assigned to the treatment Arm G [50 mg BID linsitinib plus 100 mg QD erlotinib] of the rollover study.
The primary endpoint of the study is the number of subjects with adverse events. Participants may continue on study until any of the criteria for study drug discontinuation have been met.
Approximately 62 participants will take part in this study in Brazil,Czech Republic, Germany, Poland, Romania, Russia, Singapore, Thailand, UK, and the US.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/0233
Date of REC Opinion
27 Jun 2014
REC opinion
Further Information Favourable Opinion