Condition category
Cancer
Date applied
12/02/2014
Date assigned
26/03/2014
Last edited
26/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration and not expected to be available in the future

Trial website

Contact information

Type

Scientific

Primary contact

Prof Mario Campone

ORCID ID

Contact details

Institut de Cancérologie de l'Ouest René Gauducheau
Département de Cancérologie
Boulevard Jacques Monod
Saint-Herblain
44805
France

Additional identifiers

EudraCT 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

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

Multi-centre

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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

Phase

Phase I

Drug names

Lucitanib, fulvestrant

Primary outcome measures

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 trial start date

01/02/2014

Overall trial end date

01/03/2016

Reason abandoned

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

Patient

Age group

Adult

Gender

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

01/02/2014

Recruitment end date

01/03/2016

Locations

Countries of recruitment

France

Trial participating centre

Institut de Cancérologie de l'Ouest René Gauducheau
Saint-Herblain
44805
France

Sponsor information

Organisation

Institut de Recherches Internationales Servier (France)

Sponsor details

50 rue Carnot
Suresnes
92284
France

Sponsor type

Industry

Website

http://www.servier.com/

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes