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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


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.


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


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

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