Prostate cancer MedDRA version: 8.1 Level: LLT Classification code 10007113 Term: Cancer of prostate
Conditions
Interventions
Product Name: Leuprolide acetate
Product Code: LF-LH
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: LEUPRORELIN ACETATE
CAS Number: 74381536
Concentration unit
Sponsors
Italfarmaco S.p.A.
Eligibility
Sex/Gender
Male
Inclusion 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part A: preliminary investigation of the safety, pharmacodynamics and pharmacokinetics of a new leuprolide acetate depot 3-month formulation after i.m. or s.c. administration to patients with prostate cancer. Part B: investigation of the safety, pharmacodynamics and pharmacokinetics of a new leuprolide 3-month formulation in patients with prostate cancer after administration of a single dose of 22.5 mg leuprolide acetate by i.m. or s.c. injection (according to the results of study part A, see § 3.2). ;Secondary Objective: -Main testosterone PD parameters (see § 9.2.1). -Serum FSH / LH concentrations, PSA concentrations. -WHO/ECOG performance status (scores) (see Appendix B), bone pain, urinary pain/urinary symptoms. ;Primary end point(s): Part A: - At least seven out of eight patients (i.e. 87.5%) achieving castrate levels of serum testosterone (< 0.5 ng/ml) on study day 28, and maintaining castrate levels of serum testosterone throughout the study up to study day 84 after single i.m. or s.c. injection of leuprolide acetate 22.5 mg. - Leuprolide PK parameters after single i.m. or s.c. injection of leuprolide acetate 22.5 mg. Part B: - Number of patients achieving castrate levels of serum testosterone (< 0.5 ng/ml) on study day 28 and maintaining castrate levels of serum testosterone throughout the study up to day 84 following i.m. or s.c. administration of leuprolide acetate 22.5 mg. - Leuprolide PK parameters after single i.m. or s.c. injection of leuprolide acetate 22.5 mg. | — |
Countries
United Kingdom
Outcome results
None listed