Safety and Pharmacokinetics of XL647 Administered Orally to Subjects With Solid Tumors

Summary

The primary objective of this study is as follows: * To evaluate the safety and tolerability of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors. The secondary objectives of this study are as follows: * To evaluate the plasma pharmacokinetics of XL647 administered orally as a single dose and as repeat doses in subjects with solid tumors, * To estimate renal elimination of XL647 administered orally as a single dose in subjects with solid tumors. The exploratory objective of this study is as follows: * To assess the pharmacodynamic effects of XL647 administration in plasma and peripheral blood cells. In addition, subjects may be eligible to enter a Treatment Extension Period. The following information will be obtained from this part of the study: * Long-term safety and tolerability of XL647 after repeat administration, * Tumor response after repeat administration of XL647.

Timeline

Start

2004-06

Primary completion

2007-07

Completion

2007-11

Publications

• Background Das M, Padda SK, Frymoyer A, Molina J, Adjei A, Lensing JL, Miles D, Sikic BI, Wakelee HA. A safety, tolerability, and pharmacokinetic analysis of two phase I studies of multitargeted small molecule tyrosine kinase inhibitor XL647 with an intermittent and continuous dosing schedule in patients with advanced solid malignancies. Cancer Chemother Pharmacol. 2018 Sep;82(3):541-550. doi: 10.1007/s00280-018-3646-0. Epub 2018 Jul 20.

Drugs

Indications