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 a combination of SU-014813, an oral multi-targeted tyrosine kinase inhibitor, and docetaxel. The study aimed to determine the maximal tolerated dose, evaluate pharmacokinetics, and assess preliminary anti-tumor efficacy. The recommended phase II dose was established as docetaxel 75 mg/m² with SU-014813 50 mg/day. Dose-limiting toxicities included neutropenia, neutropenic fever, fatigue, and diarrhea, while other side effects were fatigue, alopecia, nausea, vomiting, anorexia, rash, hypertension, and hair discoloration. Two patients (8%) achieved partial response, and 7 patients (29%) had disease stabilization for over 6 months, resulting in a clinical benefit rate of 37.5%. The regimen showed particular promise in patients with melanoma and sunitinib-refractory gastrointestinal stromal tumors, warranting further development.