Safety Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Pharmacodynamics of Oral MP470, a Multitargeted Tyrosine Kinase Inhibitor, in Patients With Solid Malignancies

Summary

Multicenter, open-label, dose-ranging study in two parts: maximum tolerated dose (MTD) segment (the first 28-day course of MP 470) followed by long-term safety segment. MTD segment: follows standard oncology phase-I design; within-patient dose level adjustments prohibited; each patient participates in one of three stages: 1. Accelerated Titration Stage 2. Dose Escalation/De-Escalation Stage 3. Dose Confirmation Stage

Timeline

Start

2007-05

Primary completion

2008-12

Completion

2008-12

Publications

• Tibes R, Fine G, Choy G, Redkar S, Taverna P, Oganesian A, Sahai A, Azab M, Tolcher AW. A phase I, first-in-human dose-escalation study of amuvatinib, a multi-targeted tyrosine kinase inhibitor, in patients with advanced solid tumors. Cancer Chemother Pharmacol. 2013 Feb;71(2):463-71. doi: 10.1007/s00280-012-2019-3. Epub 2012 Nov 23.

Drugs

Indications