Clinical Trials

Clinical trials are the structured studies that examine the performance of investigational drugs in patients.

Clinical trials are listed on the U.S. Government website created to give the public access to information at www.clinicaltrials.gov.

Astex has the following actively recruiting clinical trials:

 

Phases of Clinical Trials

Phase 1 clinical trials

  • Generally involve 20 to 40 volunteers or patients and typically take approximately 1 to 2 years to complete
  • Cancer trials usually involve heavily pretreated patients who may have a wide variety of tumor types
  • Designed to evaluate a drug’s safety profile and to assess the optimal safe dosage range
  • May evaluate how a drug is absorbed, distributed, metabolized and excreted from the body
  • May be expanded to phase 1b trials that test the research compound in combination with other agents to define the combined safety and dosing parameters

Phase 2 clinical trials

  • Conducted in patients who have the specific targeted disease
  • The primary purpose of these trials is to demonstrate preliminary efficacy of the drug in the target patient population
  • Studies typically take a few years to complete
  • Once trial data are obtained, showing that a specific dose and schedule has clinical efficacy that appears to be superior to other treatments, advancement to phase 3 can begin

Phase 3 clinical trials

  • Typically large, involving several hundred or even thousands of patients
  • Typically compare an investigational agent with a control product or the standard of care, which could be a product or treatment already approved for use in that disease
  • Are designed to demonstrate statistically the benefits of the new drug over current therapies
  • Form the basis of marketing approval submissions to the FDA and equivalent regulatory bodies worldwide