NCT00385775

Study of XIAP Antisense for Advanced Cancers

A Phase I Trial of AEG35156 Administered by 2-Hour Intravenous Infusion in Patients With Advanced Cancers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Aegera Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to find the maximum tolerated dose, safety and toxicity profile, and to identify any dose limiting toxicities of AEG35156 administered in 2-hour infusions to patients with advanced cancers.

Detailed description

This is a Phase I study, single-arm, open-label, dose escalation study to establish the recommended dose and activity of AEG35156 administered as a 2-hour daily infusion over 3 days initially followed by weekly 2-hour intravenous infusions in patients with advanced cancers. Subjects eligible for study entry must have proven advanced or metastatic cancer refactory to conventional treatment or for which no conventional therapy exists. The starting dose will be a fixed dose of 60 mg/day with escalation by steps of 50 to 100% in successive cohorts. Approximately of 30 patients will be entered in the study to determine the maximum tolerated dose.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	AEG35156	weekly IV solution infused over 2 hrs

Timeline

• Start date: 2006-06-01
• Primary completion: 2008-10-01
• Completion: 2008-11-01
• First posted: 2006-10-11
• Last updated: 2008-08-21

Locations

1 site across 1 country: United Kingdom