DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Safety and Efficacy Study of Leuprolide Acetate for Injectable Suspension 22.5 MG in the Treatment of Prostate Cancer

Information source: Oakwood Laboratories, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostate Cancer

Intervention: Leuprolide Acetate for Injectable Suspension (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Oakwood Laboratories, LLC

Official(s) and/or principal investigator(s):
Daniel Saltzstein, MD, Principal Investigator, Affiliation: Urology San Antonio Research PA
James Page, MD, Study Chair, Affiliation: Oakwood Laboratories, LLC
Beth Glasgow, Study Director, Affiliation: Oakwood Laboratories, LLC

Summary

The purpose of the study is to demonstrate the safety and efficacy of Leuprolide Acetate for Injectable Suspension 22. 5 mg in reducing serum testosterone to castrate levels in patients with prostate cancer.

Clinical Details

Official title: A Phase 3, Open-Label, Multi-Center, Safety And Efficacy Study of Oakwood Laboratories' Leuprolide Acetate For Injectable Suspension 22.5 mg In Patients With Prostate Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The percentage of responders who attain and maintain castrate levels of serum testosterone

Secondary outcome:

Safety as shown through laboratory parameters

Leuprolide serum profiles following administration study drug product.

Safety as shown through reported adverse events

Detailed description: This study is an open-label, multi-center study in which a minimum of 165 patients will receive one (1) of three (3) lots of Oakwood Laboratories' Leuprolide Acetate for Injectable Suspension 22. 5 mg for two cycles. A subset of patients (minimum of 12) will be assigned to each lot (A, B or C) and will have additional blood sampling to characterize leuprolide release kinetics for each dose administered.

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Reads, understands and is able and willing to sign informed consent form

- Males greater than or equal to age 45

- Histologically and cytologically documented prostate carcinoma

- Candidate for initial hormone therapy - inclusive of patients beginning neoadjuvant

or intermittent therapy, being treated locally for advanced disease, or patients beginning therapy for failure of prior local therapy

- Patients who have had prior LHRH therapy in an adjuvant or neoadjuvant setting,

providing that the last date of effective therapy was greater than 6 months prior to screening

- ECOG 0-2

- Morning serum testosterone level > 150 ng/dL

- Standard screening labs within 2x ULN (AST, ALT, bilirubin and serum creatinine)

- Hemoglobin > 10 g/dL

- Life expectancy of >1yr.

- Willing to complete both cycles and all procedures of the study

Exclusion Criteria:

- Any prior (except for prior LHRH therapy in an adjuvant or neoadjuvant setting) or

current definitive therapy for prostate cancer, including chemotherapy, immunotherapy, tumor-vaccines,biological response modifiers, or estrogens

- Patients who have undergone any prostatic surgery within 4 weeks of Baseline

- Patients who have undergone orchiectomy, adrenalectomy, or hypophysectomy

- Patients that are currently hospitalized or require frequent hospitalization

- Prior resistance to LHRH therapy, either neoadjuvant or adjuvant.

- Patients with evidence of spinal cord compression, ureteral obstruction or clinically

significant bladder outlet obstruction

- Participation in any investigational drug, biologic, or device study within five

half-lives of its physiological action or three months prior to enrollment, whichever was longer

- Patients anticipated to need concomitant hormonal, anti-androgen, radio-, chemo-,

immuno- or surgical therapy for prostate cancer while on study

- History of recent drug and/or alcohol abuse within 6 months of screening

- History of HIV, HCV or HBV infection

- History of hypersensitivity or known allergy to LHRH agonists or antagonists

- Concurrent use of daily corticosteroids or other agents known to modify serum

androgen within 12 weeks of screening visit

- Patients on other anti-androgens such as flutamide, nilutamide or bicalutamide

- History of other cancer with the exception of non-metastatic basal or squamous cell

carcinoma of the skin

- Patients receiving any type of 5-alpha reductase inhibitor such as Proscar, Propecia,

or Avodart within the past 3 months

- Patients who have experienced a myocardial infarction, unstable or uncontrolled

cardiovascular disease or a coronary vascular procedure within 6 months of Baseline

- Patients who have experienced venous thrombosis within 6 months of Baseline

- Patients with other serious intercurrent illness(es) or disease(s)that might

interfere with, or put them at additional risk for, their ability to receive the treatment outlined in the protocol

- Patients who have a history of the following: Immunization within 4 weeks of

Baseline; Flu shots within 2 weeks of Baseline; Donation or receipt of blood or blood products within 2 months of Baseline; Anaphylaxis

- Patients who have received Oakwood's leuprolide acetate formulation previously.

Locations and Contacts

Oakwood Laboratories, LLC, Oakwood Village, Ohio 44146, United States
Additional Information

Starting date: April 2007
Last updated: September 2, 2010

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017