PQR309 and Eribulin in patients with advanced breast cancer:PQR309-007
Research type
Research Study
Full title
An open label, non-randomized, multicenter phase 1/2b study investigating safety and efficacy of PQR309 and eribulin combination in patients with locally advanced or metastatic HER2 negative and triple-negative breast cancer
IRAS ID
193297
Contact name
KATARINA PETROVIC
Contact email
Sponsor organisation
PIQUR Therapeutics AG
Eudract number
2015-004225-14
Duration of Study in the UK
1 years, 7 months, 21 days
Research summary
This study will enroll adult female patients with locally advanced or metastatic breast cancer for whom no other standard therapy is available or who had at least two standard treatments previously.
This study will enroll about 60 patients in several centers in Europe (in Spain and UK)
The main purpose of the escalation part of the study is to find the highest dose of the investigational drug PQR309 in combination with eribulin (Halaven®) that can be given to patients without causing severe side effects.
The results of this part of the study will be used to determine the best dose for future patients.
Depending on how well the patients respond to treatment they could be on this study as long as they are benefiting from the treatment. Each treatment cycle is 21 days in duration. Overall study duration (including enrolling, treatment and evaluation) will range from approximately a minimum of 3 months to a maximum of 2 years.REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0140
Date of REC Opinion
10 May 2016
REC opinion
Further Information Favourable Opinion