Safety Study of Sterile Compound C31510 for Injection to Subjects With Solid Tumors
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
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