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.