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 (FINESSE)

Servier

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: lucitanib

Study type: Interventional

Funder types: Other

Identifiers

NCT02053636

2013-000288-10 (EudraCT Number)

BIG 2-13 (Other Identifier)

CL2-80881-001

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

lucitanib

Experimental group

Description:

Hard gelatine capsules of 2,5, 5 and 10 mg or film coated tablets of 5 and 7,5 mg. 5 to 10 mg orally on a daily basis until unacceptable toxicity according to the investigator, disease progression or withdrawal of consent

Treatment:

Drug: lucitanib