Phase I Safety and Pharmacokinetic Study of SU-014813 in Combination with Docetaxel in Patients with Advanced Solid Tumors

    May 2011 in “ European Journal of Cancer ”
    Maja J.A. de Jonge, Herlinde Dumez, Jos Kitzen, Benoit Beuselinck, Jaap Verweij, Ronan Courtney, Andrea Battista, Nicoletta Brega, Patrick Schöffski
    TLDR The drug combination was safe and showed promise in treating advanced tumors.
    In this Phase I study, 25 patients with advanced solid tumors were treated with SU-014813 and docetaxel to determine the maximal tolerated dose, evaluate pharmacokinetics, and assess anti-tumor efficacy. The recommended phase II dose was 75 mg/m² of docetaxel with 50 mg/day of SU-014813. Dose-limiting toxicities included neutropenia, neutropenic fever, fatigue, and diarrhea. Common side effects were fatigue, alopecia, nausea, vomiting, anorexia, rash, hypertension, and hair discoloration. The clinical benefit rate was 37.5%, with 2 patients achieving partial responses and 7 patients having stable disease for over 6 months. The combination showed manageable safety and promising anti-tumor activity, particularly in melanoma and sunitinib-refractory gastrointestinal stromal tumors, warranting further development.
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