FINESSE
Research type
Research Study
Full title
An open, 3-cohort, phase II trial testing oral administration of lucitanib in patients with FGFR1-amplified or non-amplified estrogen receptor positive metastatic breast cancer.
IRAS ID
134041
Contact name
Helen Whitrow
Contact email
Sponsor organisation
Servier Research and Development Ltd
Eudract number
2013-000288-10
Duration of Study in the UK
2 years, 5 months, 1 days
Research summary
This is an early phase study looking at the efficacy and safety of an oral drug, Lucitanib, an inhibitor of FGFR1, in patients with advanced breast cancer. Patients will be tested for FGFR1 amplification and 11q gene amplification prior to stratification, however both amplified and non-amplified patients are eligible for this study.
Response will be assessed by the following parameters
1. Objective response rate (ORR) defined as the proportion of patients for whom a confirmed complete response (CR) or partial response (PR) is observed during the treatment period (confirmed by RECIST criteria).
2. Clinical Benefit Rate (CBR) defined as the proportion of patients for whom a confirmed CR, PR or prolonged stable disease (SD) during treatment for at least 24 weeks from inclusion.
3. Progression Free Survival (PFS)
4. Response durationSafety and pharmacokinetics of lucitanib will also be evaluated.
There are three patient cohorts in this study – (i) FGFR1-amplified, (ii) FGFR1-non amplified with 11q-ampliciation and (iii) FGFR1-non-amplified without 11q-amplification).
The study is designed in two stages. Initially (stage 1), 21 patients will be enrolled in each cohort. If at least 2 patients in a given cohort showed evidence of response (as defined above) then a further 20 patients will be enrolled in this cohort (stage 2).
REC name
London - Chelsea Research Ethics Committee
REC reference
13/LO/1417
Date of REC Opinion
24 Oct 2013
REC opinion
Favourable Opinion