Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy
Completed
PRAECIS Pharmaceuticals Inc.
Phase 2
2004-05-01
This is a Phase 2, open-label study in subjects with androgen-independent prostate cancer who
have progressed following treatment with an LHRH agonist. Up to 22 subjects will be enrolled.
Enrollment will be monitored to ensure that not all subjects are enrolled based on rising
prostate specific antigen (PSA) criterion only.
Subjects will be treated with abarelix (Plenaxis) 100 mg intramuscularly (IM) every 2 weeks
for 12 weeks (total dose of 600 mg).
Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV
commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated
population of patients receiving Plenaxis®. The purpose of the study is to estimate the
incidence of immediate-onset systemic allergic reactions in the indicated population
receiving Plenaxis® and to determine whether the hazard rate changes over time.
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