Clovis Oncology has started dosing in its open-label, randomised, multi-centre Phase II trial of lucitanib in patients with FGF-aberrant, advanced breast cancer.
Lucitanib is an oral, potent inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors 1 and 2 (FGFR1-2), vascular endothelial growth factor receptors 1 through 3 (VEGFR1-3) and platelet-derived growth factor receptors alpha and beta (PDGFR a-ß).
Around 160 patients with FGFR1 or 11q-amplified, advanced breast cancer will be enrolled in the Phase II trial, which will assess the lucitanib dosing strategy, by comparing the progression-free survival of patients receiving 10mg or 15mg daily.
The trial is also designed to evaluate overall response rate, duration of response, safety, tolerability, and pharmacokinetics of lucitanib.
Vanderbilt-Ingram Cancer Center associate director for Clinical Research, director of the Center for Cancer Targeted Therapies, and director of the Breast Cancer Program Carlos Arteaga said: "Early lucitanib data are encouraging, and suggest that determination of genetic alterations in the FGF pathway may be important to identify the patients most likely to benefit from lucitanib treatment.
"This study will further explore two doses of lucitanib in patients with FGF-aberrant breast cancer, a population which possesses these genetic alterations, and for whom new treatment options are needed."
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The Phase II trial is part of a global development programme for lucitanib in breast cancer, which includes the Servier-sponsored FINESSE trial of lucitanib monotherapy being conducted in Europe, Canada and Australia as well as the Servier-sponsored INES trial evaluating lucitanib in combination with fulvestrant after failure of endocrine therapy.
In addition, a Clovis-sponsored Phase II trial assessing lucitanib in patients with FGFR1-amplified, squamous non-small cell lung cancer is scheduled to be initiated shortly.
Clovis Oncology president and CEO Patrick Mahaffy said: "We are pleased to move forward with our study of lucitanib in patients with FGF-aberrant breast cancer, which complements the Servier programmes already underway.
"The Phase 1/2a data presented to date are compelling and we look forward to confirming the optimal dose and schedule of lucitanib in this study."
The company said that by targeting the FGFR, VEGFR and PDGFR receptors, lucitanib also can inhibit the development of blood vessels that are required by the tumour to grow and spread.