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

This study has been completed.
Sponsor:
Information provided by:
PRAECIS Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:
NCT00100243
First received: December 27, 2004
Last updated: September 18, 2006
Last verified: September 2006
  Purpose

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).


Condition Intervention Phase
Prostate Cancer
Drug: Plenaxis
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy

Resource links provided by NLM:


Further study details as provided by PRAECIS Pharmaceuticals Inc.:

Primary Outcome Measures:
  • Clinical adverse events, laboratory abnormalities, and withdrawals due to adverse events
  • Serum FSH levels below the lower limit of quantitation (LLOQ) on Days 57 and 85

Estimated Enrollment: 22
Study Start Date: May 2004
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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 #1. 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
  • PSA ≥ 5 ng/mL (if progression is determined from a rise in PSA)
  • WBC greater than or equal to 3,000/mm3
  • Hematocrit ≥ 30%
  • Platelet count greater than or equal to 100,000/mm3
  • Serum creatinine less than or equal to 2 x upper limit of normal (ULN)
  • Bilirubin (direct or total) less than or equal to 2 x ULN
  • SGPT (ALT) and SGOT (AST) less than or equal to 2 x ULN

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
  • Major surgery within 4 weeks
  • Serious medical illnesses, including malnutrition, that in the judgment of the investigator would preclude protocol treatment
  • Significant cardiovascular illness defined as NYHA class III or IV congestive heart failure or unstable angina within 6 months, myocardial infarction within 12 months, deep venous thrombosis within 2 years, or any history of acute pulmonary embolism
  • Active second malignancy other than non-melanoma skin cancer or superficial bladder cancer
  • Any uncontrolled infection, including HIV
  • Any other experimental therapy within 4 weeks prior to study entry
  • QTc > 450 msec on a screening ECG obtained by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00100243

Locations
United States, California
San Diego Center for Urology
La Mesa, California, United States, 91942
United States, Florida
Southwest Florida Urological Associates
Fort Myers, Florida, United States, 33907
Panama City Urological Center
Panama City, Florida, United States, 32405
United States, Ohio
Columbus Urology Research, LLC
Columbus, Ohio, United States, 43214
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97201-3098
United States, Pennsylvania
Urological Associates of Lancaster
Lancaster, Pennsylvania, United States, 17604-3200
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Sponsors and Collaborators
PRAECIS Pharmaceuticals Inc.
Investigators
Study Director: Marc Garnick, MD PRAECIS Pharmaceuticals Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00100243     History of Changes
Other Study ID Numbers: 149-04-01
Study First Received: December 27, 2004
Last Updated: September 18, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by PRAECIS Pharmaceuticals Inc.:
androgen-independent
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Androgens
Abarelix
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Hormone Antagonists

ClinicalTrials.gov processed this record on July 24, 2014