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