- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00598312
Safety and Efficacy Study of Leuprolide Acetate for Injectable Suspension 22.5 MG in the Treatment of Prostate Cancer
September 2, 2010 updated by: Oakwood Laboratories, LLC
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
201
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ohio
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Oakwood Village, Ohio, United States, 44146
- Oakwood Laboratories, LLC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The percentage of responders who attain and maintain castrate levels of serum testosterone
Time Frame: From Day 28 to Day 168.
|
From Day 28 to Day 168.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety as shown through laboratory parameters
Time Frame: Day 0 - Day 168
|
Hematology, chemistry and urinalysis
|
Day 0 - Day 168
|
Leuprolide serum profiles following administration study drug product.
Time Frame: Day 0 - Day 168
|
Leuprolide levels (ng/dL) measured at designated time points to determine a pharmacokinetic profile for the product.
|
Day 0 - Day 168
|
Safety as shown through reported adverse events
Time Frame: Day 0 -168
|
Day 0 -168
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Saltzstein, MD, Urology San Antonio Research PA
- Study Chair: James Page, MD, Oakwood Laboratories, LLC
- Study Director: Beth Glasgow, Oakwood Laboratories, LLC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
August 1, 2008
Study Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
January 10, 2008
First Submitted That Met QC Criteria
January 10, 2008
First Posted (Estimate)
January 21, 2008
Study Record Updates
Last Update Posted (Estimate)
September 8, 2010
Last Update Submitted That Met QC Criteria
September 2, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OL-01110
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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