Clinical Trials Overview

Pharmacyclics is conducting a comprehensive clinical program for the development of our pipeline molecules (summarized in table below).

If you are a health care provider interested in having a patient participate in our clinical trials, please visit www.clinicaltrials.gov to find clinical trial site(s) in your area.

If you are a patient who is interested in getting on our clinical trials, please speak to your health care provider and visit the NIH clinical trials website to find a clinical trial site in your area.

Information on all Pharmacyclics studies, including descriptions of studies, enrollment status, participating study centers, and appropriate contact information can be found on the National Institutes of Health (NIH) website: www.clinicaltrials.gov, or information on each individual trial can be accessed by the links provided in the table below:

Currently, Pharmacyclics does not have an expanded access program for any of our pipeline molecules. Access to our molecules is only available to patients enrolled in a clinical trial. For information on Pharmacyclics clinical trials and to find clinical trial sites in your area, please visit the NIH Clinical Trials website.

PHASE I TRIALS: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.

PHASE II TRIALS: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.

PHASE III TRIALS: Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.

PHASE IV TRIALS: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

Source: ClinicalTrials.gov; Retrieved on April 20, 2011 from http://clinicaltrials.gov/ct2/info/glossary#phasel