Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
CL1-80881-002
Study information
Scientific title
Phase Ib dose allocation study of oral administration of lucitanib given in combination with fulvestrant in patients with oestrogen receptor-positive and FGFR1-amplified or non-amplified metastatic breast cancer
Acronym
Study hypothesis
To establish the safety profile and the recommended Phase II dose of lucitanib in combination with fulvestrant
Ethics approval(s)
Ethics approval was obtained before recruitment of the first participants
Study design
Multicentric open non-comparative phase Ib study
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
FGFR1-amplified or non-amplified estrogen receptor positive metastatic breast cancer
Intervention
1. Capsules containing 5, 10 or 15 mg of lucitanib taken orally on a daily basis, treatment duration at the investigator's discretion
2. Concomitant intramuscular injection of fulvestrant 500 mg on a monthly basis
The study is composed of two successive parts: the dose allocation (Continual Reassessment Method) and the dose expansion part.
For the dose allocation cohorts, a minimum of three patients will be enrolled at the initial dose level of 10 mg once per day in combination with fulvestrant. Patients will be included by groups of three. A minimum of nine patients will be included at the Maximal Tolerated Dose. Intra-patient dose-escalation will be considered in the patient's best interest.
For the dose expansion part, two cohorts of 14 patients will be treated with the lucitanib Recommended Dose defined in the dose allocation part of this study in combination with fulvestrant given on a monthly basis.
In both parts, each patient will receive the combination of lucitanib with fulvestrant until unacceptable toxicity according to the investigator, disease progression or patient withdrawal. The maximum number of cycles is at the discretion of the investigator.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase I
Drug/device/biological/vaccine name(s)
Lucitanib, fulvestrant
Primary outcome measure
1. Maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of lucitanib in combination with fulvestrant, at the end of dose allocation cycles
2. Safety profile of lucitanib in combination with fulvestrant at each visit
Secondary outcome measures
1. Clinical benefit rate (CBR), progression-free survival (PFS) and duration of response over the study
2. Pharmacokinetic and pharmacodynamic profile of lucitanib in combination with fulvestrant at each cycle
Overall study start date
01/02/2014
Overall study end date
06/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Menopausal women aged 18 years old or over
2. Histologically confirmed breast adenocarcinoma
3. Relapsing during or after treatment with fulvestrant
4. Tumour progression at study entry demonstrated by radiological assessment
5. Adequate haematological, hepatic and renal functions
Participant type(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
Female
Target number of participants
46
Participant exclusion criteria
1. Previously treated with more than three chemotherapy regimen in the metastatic/advanced setting
2. Previous treatment with bevacizumab within 3 months before the first day of lucitanib administration
3. Active central nervous system metastases, cerebral oedema, and/or progressive growth
4. Patients with impaired cardiac function
5. Serum potassium level below lower limit of normal
6. Uncontrolled hypothyroidism
7. Pregnant or breastfeeding women
8. Patient with any other concomitant severe and/or uncontrolled medical condition that would, in the investigators' opinion, contraindicate patient participation in the clinical study
Recruitment start date
04/04/2014
Recruitment end date
25/10/2015
Locations
Countries of recruitment
France
Study participating centre
Institut de Cancérologie de l'Ouest René Gauducheau
Saint-Herblain
44805
France
Study participating centre
Institut Gustave Roussy
Dept d'oncologie - Cancer du sein
VilleJuif
94805
France
Study participating centre
Centre Léon BERARD
Service d'oncolgie
Lyon
69008
France
Study participating centre
Centre Jean Perrin
Clermont Ferrand
63011
France
Sponsor information
Organisation
Institut de Recherches Internationales Servier (France)
Sponsor details
50 rue Carnot
Suresnes
92284
France
Sponsor type
Industry
Website
ROR
Funders
Funder type
Industry
Funder name
Institut de Recherches Internationales Servier (France)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Summary results will be published on www.clinicaltrials.servier.com within 12 months after the end of the study
Intention to publish date
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study will be available upon request from www.clinicaltrials.servier.com after the Marketing Authorisation has been granted.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | No | No | |||
| Results article | 18/07/2022 | 18/07/2022 | Yes | No |