PTC299 and Hormonal Agent for Treatment of Metastatic Breast Cancer
Status:
Completed
Trial end date:
2012-03-01
Target enrollment:
Participant gender:
Summary
Formation of new blood vessels (angiogenesis) is important for tumor growth in metastatic
breast cancer. It is known that tumors make a protein called vascular endothelial growth
factor (VEGF) and there are higher levels of VEGF in the tumors and blood of many women with
metastatic breast cancer. VEGF stimulates the formation of blood vessels that supply the
tumor with nutrients and oxygen. PTC299 is an oral drug that has been shown to decrease
production of VEGF in animal models of human cancer. In these animal models, oral PTC299
administration decreases VEGF levels in the tumor and in the bloodstream, decreases blood
vessel numbers in the tumor, and significantly slows or halts tumor growth. Safety studies in
research animals indicate good tolerability at doses and drug levels that are higher than
those planned for the clinical studies. Results from Phase 1a studies in healthy volunteers
indicate that PTC299 achieves levels of PTC299 in the bloodstream that are known to be active
in animal models of human cancer. This Phase 1b study is designed to test the hypothesis that
PTC299 will be tolerable and will show evidence of VEGF reduction and antitumor activity when
administered orally in combination with anastrozole (Arimidex®), letrozole (Femara®), or
exemestane (Aromasin®) to women with metastatic breast cancer.