The phase I study evaluated patients with advanced solid tumors who had failed prior treatments with a range of anticancer therapies.
A total of 43 patients have received the combination therapy of ARQ 501 and docetaxel in this trial with different doses of ARQ 501. Promising anti-tumor activity has been observed over the range of doses administered. Of 36 patients evaluable for efficacy, 20 achieved disease stabilization, and evidence of tumor regression was observed in 4 of these patients, 3 of whom had a partial response and 1 of whom had a minor response.
The most common adverse events were anemia, fatigue, hyperbilirubinemia and leucopenia.
“These data confirm the potential of ARQ 501 when used as combination therapy with chemotherapeutic agents,” said Dr Stephen Hill, president and CEO of ArQule.
ARQ 501 is being developed under an alliance with Roche. The company’s phase II clinical program with ARQ 501 consists of three separate trials, including two monotherapy trials, in leiomyosarcoma and head and neck cancer, and one combination therapy trial, with gemcitabine in pancreatic cancer.