Phase IIb trial of ozarelix — a new LHRH receptor antagonist


According to a corporate media release, a company called Spectrum Pharmaceuticals has initiated enrollment of an additional 150 patients into a Phase IIb trial of a new LHRH receptor antagonist called ozarelix (a drug with a similar mechanism of action to degarelix or Firmagon) for the treatment of advanced forms of prostate cancer.

This trial is an international, multi-center, randomized, open-label study designed to assess the safety and efficacy of monthly dosing with ozarelix (administered subcutaneously) compared to treatment with a depot formulation of goserelin acetate. Two patients will be randomized to receive ozarelix for each patient randomized to receive goserelin acetate.

Patients will be followed for a total of 84 days, and the primary outcome will be the percentage of patients who achieve a serum testosterone level ≤ 50 ng/dl from day 28 through day 84. Additional details about the trial can be found on the ClinicalTrials.gov web site (but the information on the relevant page appears to need to be updated).

2 Responses

  1. If you learn of trial sites, let us know. I tried to access what you provided but internet said unable to connect.

  2. Chuck: Sorry … technical issue; links now updated.

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