Pharmacokinetics, pharmacodynamics and safety of a new Leuprolide acetate 22.5 mg depot formulation, when given as palliative treatment to prostate cancer patients

Italfarmaco S.p.A.0 sites20 target enrollmentJanuary 7, 2007

ConditionsProstate cancer MedDRA version: 8.1Level: LLTClassification code 10007113Term: Cancer of prostate

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prostate cancer
Sponsor: Italfarmaco S.p.A.
Enrollment: 20
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

January 7, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

Italfarmaco S.p.A.

Eligibility Criteria

Inclusion Criteria

•1\.Males \>\= 18 years of age, with histologically proven carcinoma of prostate, who might benefit from medical androgen deprivation therapy;
•2\.life expectancy of at least 1 year;
•3\.World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1, or 2;
•4\.adequate renal function at screening as defined by serum creatinine \<\= 1\.5 times the upper limit of normal (ULN) for the clinical laboratory;
•5\.adequate and stable hepatic function as defined by bilirubin \<\= 1\.5 times the ULN and transaminases (i.e. AST, ALT) \<\= 2\.5 times the ULN for the clinical laboratory at screening;
•6\.ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co\-operate with the Investigator and to comply with the requirements of the entire study;
•7\.signed written informed consent prior to inclusion in the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

•Evidence of brain metastases, taking into account medical history, clinical observations and symptoms; evidence of spinal cord compression, taking into account medical history, clinical observations and symptoms; evidence of severe urinary tract obstruction with threatening urinary retention, taking into account medical history, clinical observations and symptoms; presence of any tumour in the immediate vicinity which could cause cord compression; severe pain from extensive osseous deposits, taking into account medical history, clinical observations and symptoms; testosterone levels less than 1\.5 ng/mL at screening, locally determined at the laboratory of each clinical site; previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g. antibody therapies, tumour\-vaccines), biological response modifiers (e.g. cytokines) within 3 months of baseline; previous hormonal therapy for treatment of prostate cancer, such as LHRH analogues (no wash\-out allowed); previous treatment with androgen receptor blockers, such as Casodex®, Fugerel®, Megace®, Androcur® (no wash\-out allowed); previous orchiectomy, adrenalectomy or hypophysectomy; previous prostatic surgery within 2 weeks of baseline; previous local therapy to the primary tumour with a curative attempt other than surgery within 2 weeks of baseline; any investigational drug within 5 half\-lives of its pharmacological action or 3 months, whichever is longer, before baseline; administration of 5\-?\-reductase inhibitors within 3 months before baseline; OTC or alternative medical therapies which have an estrogenic or anti\-androgenic effect within the 3 months before baseline; haematological parameters outside 20% of the upper or lower limits of normal for the clinical laboratory at screening;
•co\-existent malignancy other than prostate cancer; uncontrolled congestive heart failure, myocardial infarction or a coronary vascular procedure or significant symptomatic cardiovascular disease(s) within 6 months before baseline; resting uncontrolled hypertension: (? 160/100 mmHg) or symptomatic hypotension within 3 months before baseline; venous thrombosis within 6 months of baseline;
•uncontrolled diabetes (patients with uncontrolled diabetes need to compensate the metabolic disorder before treatment with LH\-RH analogues); history of drug and/or alcohol abuse within 6 months of baseline; serious concomitant illness(es) or disease(s) that may interfere with, or put patients at additional risk for, their ability to receive the treatment outlined in the protocol; patients on anticoagulant therapy; blood donations/losses within 2 months of baseline, apart from previous prostatic surgery patients; known hypersensitivity to GnRH, GnRH agonist, including any LHRH analogues, or any excipients of the study formulation
•history of the following prior to the study: immunization (within 4 weeks of baseline); flu shots (within 2 weeks of baseline); anaphylaxis; skin disease which would interfere with injection site evaluation; dermatographism will be documented at screening and followed up while on treatment