Phase 2 Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy

PRAECIS Pharmaceuticals Inc.7 sites in 1 country22 target enrollmentMay 2004

ConditionsProstate Cancer

DrugsPlenaxis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Prostate Cancer
Sponsor: PRAECIS Pharmaceuticals Inc.
Enrollment: 22
Locations: 7
Primary Endpoint: Clinical adverse events, laboratory abnormalities, and withdrawals due to adverse events
Status: Completed
Last Updated: 19 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

September 2005

Last Updated

19 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

PRAECIS Pharmaceuticals Inc.

Eligibility Criteria

Inclusion Criteria

•Signed informed consent
•Histologically or cytologically confirmed prostate cancer that has progressed within 60 days of the start of screening despite castrate levels of testosterone from treatment with an LHRH agonist. Progression will be defined as one or more of the following: \*A rising PSA, defined as at least two consecutive rises in PSA over a reference value (PSA #1). The first rising PSA (PSA #2) must be taken at least one week after PSA #
•A third PSA (PSA #3) is required to be greater than PSA #2; if not, a fourth PSA (PSA #4) is required to be greater than PSA #2, OR
•The appearance of new metastatic lesions on a bone scan, OR
•Progression of known lesions or the appearance of new metastatic lesions on CT, MRI, chest x-ray, or other radiographic evaluations.
•Subject whose hormonal therapy includes an anti-androgen must have the anti-androgen discontinued prior to the start of screening (at least 6 weeks for bicalutamide and at least 4 weeks otherwise). If there is a reduction in the PSA after anti-androgen withdrawal, the subject must continue to demonstrate progression as defined above after anti- androgen withdrawal to be eligible.
•ECOG Performance Status ≤ 3
•Age ≥ 18 years of age
•Life expectancy ≥ 6 months
•Serum testosterone less than or equal to 50 ng/dL

Exclusion Criteria

•A subject is ineligible to participate in the study if he meets any of the following criteria:
•Prior treatment for prostate cancer with:
•Chemotherapy
•Radiopharmaceutical such as strontium or samarium
•Diethylstilbesterol or another estrogen agonist or antagonist
•Ketoconazole
•Aminoglutethimide
•Current treatment with Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medication
•Currently taking PC SPES
•History of allergy to a LHRH agonist or GnRH antagonist