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

NCT01456182 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2012-01-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Afexa Life Sciences Inc

    lead INDUSTRY

Principal Investigators

  • Leslie R Ellis, MD · Wake Forest University Health Sciences Center

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2013-03-31
Completion
2013-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456182 on ClinicalTrials.gov