NCT01456182

Phase 1B- Open Label Dose-Ranging Study of Oral AFX-2 in Adults With Chronic Lymphocytic Leukemia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Afexa Life Sciences Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will assess the tolerability and safety of AFX-2 over a range of five dose levels in adults with low-, intermediate- or high-risk Chronic Lymphocytic Leukemia (CLL). The trial will also determine the impact of dose on quality of life indices and on biological and immune responses, and will assess if there is a maximum tolerated dose and/or dose-limiting toxicity in this study population.

Conditions

• Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Type	Name	Description
DRUG	AFX-2	Dose level 1
DRUG	AFX-2	Dose level 2
DRUG	AFX-2	Dose level 3
DRUG	AFX-2	Dose level 4
DRUG	AFX-2	Dose level 5

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-03-01
• Completion: 2013-05-01
• First posted: 2011-10-20
• Last updated: 2012-01-25

Locations

3 sites across 1 country: United States