Clinical Trials
An Overview
A clinical trial is a research study of potential new medicines conducted in human volunteers to answer specific health questions. The U.S. Food and Drug Administration (FDA) requires a series of carefully conducted clinical trials of all drugs to determine whether they should be approved for wider use in the general population.
The Investigational New Drug Application
An investigational new drug application (“IND”) is required and must be approved by the FDA before the initiation of clinical trials of a new drug compound or biological product in the U.S. The IND generally includes detailed information about product manufacture and control, the results of pre-clinical studies evaluating the safety and efficacy of the drug, and detailed descriptions of planned clinical investigations in humans.
The Phases of Clinical Trials
Clinical trials may be conducted at hospitals and research centers in the U.S. and abroad. They are normally completed in sequential phases (Phases I-IV), although the phases may overlap. Each phase has a different purpose and provides data to help scientists learn more about a particular new or experimental drug.
Phase I trials are concerned primarily with the safety and pharmacokinetics of the investigational drug. Phase II trials are designed primarily to evaluate effectiveness and safety in treating a particular disease or condition. Phase III trials are typically large clinical trials intended to gather detailed information on the safety and effectiveness of a drug. These trials are used to determine whether the drug will effectively treat a disease and to better define its side effects, as well as to generate information for proper labeling of the drug. When data is required from long-term use of a drug following its approval and initial marketing, the FDA can require Phase IV, or post-marketing, studies to be conducted.
Individuals should learn as much as possible about the clinical trials that interest them. For further information on clinical trials, please visit the web site of the U.S. Food and Drug Administration, http://www.fda.gov, or a site sponsored by the U.S. National Institutes of Health, http://www.clinicaltrials.gov.
ArQule's Clinical Trials
ArQule currently has two clinical-stage products.
ARQ 197
ARQ 197 is an orally administered drug that is in Phase 2 clinical testing among patients with multiple types of solid tumors. Initial Phase 2 trials with ARQ 197 are being conducted in patients with MiT (Microphthalmia Transcription Factor) tumors and pancreatic cancer. Additional trials are planned to begin in 2008.
ARQ 501
ARQ 501 is an intravenously administered drug that has completed proof-of-principle Phase 2 clinical trials consisting of monotherapy trials in leiomyosarcoma and head and neck cancer, and a combination therapy trial in pancreatic cancer with gemcitabine. Further development of this compound is subject to a decision by Roche regarding its option to license rights to our E2F-1 program, which includes ARQ 501 and ARQ 171, and a pre-clinical product, ARQ 761.
Patients and Physicians
How Do I Enroll?
Only you and your doctor should decide whether your enrollment in a clinical trial is right for you.
Patients, physicians and other healthcare professionals seeking more information about ArQule’s clinical trials may e-mail arquleclinical@arqule.com or call 1-800-373-7827 within the U.S. and Canada.
These products are investigational and have not been approved by the Food and Drug Administration.