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news.Aveo Pharmaceuticals, a biotechnology company, has initiated a Phase Ib/IIa clinical trial in breast cancer, expanding on the broad development program for its lead product candidate, the novel, oral triple VEGF receptor inhibitor AV-951.
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This is the third cancer indication being explored by Aveo for the potential combined use of AV-951 with leading targeted agents or chemotherapeutic regimens.
The company has launched the Phase Ib portion of this new open-label study at leading cancer institutions in the US and EU, to evaluate the combined daily dose of escalating, sequential doses of oral AV-951 with standard weekly intravenous administration of paclitaxel in patients with advanced breast cancer.
Safety, tolerability and maximum tolerated dose (MTD) will be observed as the primary outcomes of the Phase Ib portion of this Phase Ib/IIa trial in approximately 20 patients with progressive disease. Once MTD is determined, the subsequent Phase IIa portion of the trial will evaluate clinical activity of a combined AV-951/paclitaxel treatment regimen in 25-50 patients with metastatic breast cancer and no prior exposure to chemotherapy or VEGF-targeted therapies.
In parallel with this Phase Ib/IIa combination trial, Aveo will study global and targeted gene expression patterns in all patients to evaluate biomarkers for response and patient selection.
Tuan Ha-Ngoc, president and CEO of Aveo, said: This Phase Ib/IIa clinical trial of oral AV-951 in combination with paclitaxel is a strong addition to our development program for AV-951, led by our Phase II monotherapy study in renal cell carcinoma, as well as our ongoing combination therapy trials in renal and colorectal cancer.