Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

All Drugs and Chemicals

Androgens

Abarelix

Hormones

Hormone Antagonists

Plenaxis

Marc Garnick, MD

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).

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

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

PRAECIS Pharmaceuticals Inc.

Immune System Diseases

Hypersensitivity

Gerald Riedel, PhD

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.

This is a postmarketing patient safety study in the FDA indicated population of patients receiving Plenaxis®. On a quarterly basis, patients enrolled in the Plenaxis® Experience Study will have their charts audited to record the number of immediate-onset systemic allergic reactions that may occur while receiving Plenaxis®. The study will close when 2,000 patients have been enrolled. If immediate onset allergic reactions occur, patients may be eligible to enroll in a second protocol (skin testing in patients who experience an immediate onset allergic reaction). Collection of all immediate-onset systemic allergic reactions will continue for each patient enrolled in the study until the patient discontinues Plenaxis® for any reason, the patient withdraws consent to continue in the study or the patient is lost to follow-up.

The Plenaxis® Experience Study

Incidence of Immediate Onset Systemic Allergic Reactions in Patients Treated With Plenaxis®

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy	NCT00100243	Prostate Cancer	Plenaxis	18 Years -	PRAECIS Pharmaceuticals Inc.
The Plenaxis® Experience Study	NCT00103623	Prostate Cancer	Plenaxis	18 Years -	PRAECIS Pharmaceuticals Inc.

Spots Global Cancer Trial Database for plenaxis

Every month we try and update this database with for plenaxis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for plenaxis

Every month we try and update this database with for plenaxis cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for plenaxis cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.