NCT00949559

Pharmacodynamics (PD) and Pharmacokinetics (PK) Study of EP-100 in Advanced Solid Tumors

A Phase 1, Multi-center, Open-label, Dose-escalation, Safety, Pharmacodynamic and Pharmacokinetic Study of EP-100 Given Intravenously 3 Out of 4 Weeks in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Esperance Pharmaceuticals Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being done to: * Test the safety of EP-100 and see what effect (good and bad) it has on the patient and their cancer; * Find the highest dose of EP-100 that can be given without causing bad side effects; * Examine how much EP-100 is in the blood at certain times after it is given and how quickly the body gets rid of it; * Observe whether there is any effect of EP-100 on the size and activity of cancer in the patient's body.

Conditions

• Solid Tumors
• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	EP-100	as a single agent administered intravenously twice weekly x 3 with 1 week off (total 28 days)

Timeline

• Start date: 2009-07-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2009-07-30
• Last updated: 2012-04-04

Locations

2 sites across 1 country: United States