Safety Study of Sterile Compound C31510 for Injection to Subjects With Solid Tumors

Summary

The primary objective of this clinical study is as follows: • To determine the MTD and to assess the safety and tolerability of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors The secondary objective of this study is as follows: • To evaluate plasma PK and estimate renal elimination of C31510 administered as a single 4-hour IV infusion (up to nine different dosages) in subjects with solid tumors The exploratory objectives of this study are as follows: * To evaluate the pharmacodynamic correlates of C31510 activity in plasma and peripheral blood cells * To radiographically evaluate the effects of C31510 on tumors. In selected subjects, the effects on vascular permeability will be assessed by digital contrast enhanced (DCE)-magnetic resonance imaging (MRI) * To evaluate tumor response (preliminary antitumor activity) after repeat administration of C31510 * Long-term safety and tolerability of C31510 after repeat administration

Timeline

Start

2011-01

Primary completion

2012-08

Completion

2014-05

Drugs

Indications