Overview

A Phase II Trial Testing Oral Administration of Lucitanib in Patients With Fibroblast Growth Factor Receptor (FGFR)1-amplified or Non-amplified Estrogen Receptor Positive Metastatic Breast Cancer

Status:
Completed
Trial end date:
2017-04-04
Target enrollment:
0
Participant gender:
Female
Summary
The aim of the study is to evaluate the objective response rate (ORR) of single agent lucitanib in metastatic breast cancer patients with FGFR1-amplified, FGFR1-non amplified with 11q amplification, or FGFR1-non amplified without 11q amplification.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institut de Recherches Internationales Servier
Servier
Collaborator:
Breast International Group
Treatments:
Estrogens
Criteria
Inclusion Criteria:

- Histologically confirmed breast adenocarcinoma.

- Presence of an accessible metastatic lesion for biopsy or at least one archived
metastatic tumour sample.

- Prior first-line systemic therapy in the metastatic setting.

- Demonstrated progression of disease by radiological or clinical assessment.

- Female patient, aged ≥18 years old.

- Estimated life expectancy >3 months.

- Normal Left ventricular function

- Adequate haematological, hepatic and renal functions.

- For women with childbearing potential, a negative pregnancy test prior to initiation
of the study drug and willingness to use an effective contraception.

- Ability to swallow oral capsules or tablets.

Exclusion Criteria:

- More than two lines of chemotherapy with or without targeted therapy in the metastatic
setting.

- Previous treatment with bevacizumab within 3 months of first dose of Investigational
Medicinal Product.

- Active central nervous system metastases, cerebral oedema, and/or progressive growth.

- Patients with impaired cardiac function.

- Uncontrolled arterial hypertension

- Patients with history of thrombotic disorders or hereditary risk factors of
thromboembolic events

- Serum potassium level below Lower Limit of Normal

- Uncontrolled hypothyroidism.

- Pregnant or breastfeeding women.