Phase Ib dose allocation study of oral administration of lucitanib given in combination with fulvestrant in patients with metastatic breast cancer
| ISRCTN | ISRCTN23201971 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23201971 |
| Protocol serial number | CL1-80881-002 |
| Sponsor | Institut de Recherches Internationales Servier (France) |
| Funder | Institut de Recherches Internationales Servier (France) |
- Submission date
- 12/02/2014
- Registration date
- 26/03/2014
- Last edited
- 18/07/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
Prof Mario Campone
Scientific
Scientific
Institut de Cancérologie de l'Ouest René Gauducheau
Département de Cancérologie
Boulevard Jacques Monod
Saint-Herblain
44805
France
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentric open non-comparative phase Ib study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| 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 |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Lucitanib, fulvestrant |
| Primary outcome measure(s) |
1. Maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of lucitanib in combination with fulvestrant, at the end of dose allocation cycles |
| Key secondary outcome measure(s) |
1. Clinical benefit rate (CBR), progression-free survival (PFS) and duration of response over the study |
| Completion date | 06/03/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 46 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 04/04/2014 |
| Date of final enrolment | 25/10/2015 |
Locations
Countries of recruitment
- France
Study participating centres
Institut de Cancérologie de l'Ouest René Gauducheau
Saint-Herblain
44805
France
44805
France
Institut Gustave Roussy
Dept d'oncologie - Cancer du sein
VilleJuif
94805
France
VilleJuif
94805
France
Centre Léon BERARD
Service d'oncolgie
Lyon
69008
France
Lyon
69008
France
Centre Jean Perrin
Clermont Ferrand
63011
France
63011
France
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/07/2022 | 18/07/2022 | Yes | No | |
| Basic results | No | No | |||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/07/2022: Publication reference added.
23/03/2018: Basic results added, publication and dissemination plan and IPD sharing statement updated.
09/03/2017: The overall trial end date was changed from 01/03/2016 to 06/03/2017.
