NCT01251562

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

A Phase 1 Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Sterile Compound c31510 for Injection Administered Intravenously to Subjects With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: BPGbio · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	Sterile Compound C31510 for Injection	During the treatment period, subjects in each initial dose level cohort will have a single 4-hour IV infusion of C31510 at the assigned dose level of their particular cohort, three times per week for 26 days (on Day 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26) followed by a 28-day follow up period that will be counted from the first dose given on Day 1. In the absence of unacceptable toxicity or disease progression during the treatment period, those subjects may receive similar 28-day repeat treatment cycles of 3 times per week for up to 1 year, at the discretion of the investigator.

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-08-01
• Completion: 2014-05-01
• First posted: 2010-12-02
• Last updated: 2025-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study