Advanced Prostate Carcinoma MedDRA version: 19.0 Level: LLT Classification code 10036921 Term: Prostate carcinoma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Leuprolide Mesylate for injectable suspension 50mg
Product Code: LMIS 50 mg
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: LEUPROLIDE MESYLATE
C
Sponsors
Foresee Pharmaceuticals Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion Criteria (1) Males aged = 18 years old (2) Males with histologically confirmed carcinoma of the prostate (3) Subjects who are judged by the attending physician and/or Principal Investigator to be a candidate for androgen ablation therapy (4) Baseline morning serum testosterone level >150 ng/dL (5) ECOG Performance score = 2 (6) Life expectancy of at least 18 months (7) Laboratory values o Absolute neutrophil count = 1,500 cells/µL o Platelets = 100,000 cells/µL o Hemoglobin = 10 gm/dL o Total bilirubin = 1.5 × upper limit of normal (ULN) o AST (SGOT) = 2.5 × ULN o ALT (SGPT) = 2.5 × ULN o Serum creatinine = 1.5 mg/dL o Lipid profile within acceptable range according to investigator's opinion o Serum glucose within acceptable range according to investigator's opinion o HgbA1c within acceptable range according to investigator's opinion o Clinical chemistries (K, Na, Mg, Ca and P) acceptable range according to investigator's opinion o Urinalysis within normal range according to investigator's opinion (8) Agree to use male contraceptive methods during study trial (9) In the Investigator’s opinion, the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the Investigator and to participate in, and to comply with, the requirements of the entire protocol (10) All aspects of the protocol explained and written informed consent obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 123
Exclusion criteria
Exclusion criteria: Main exclusion criteria: (1) Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti-androgen therapy concomitantly, or within 8 weeks prior to Screening Visit, for treatment of carcinoma of the prostate. Radiation for pain control will be allowed during the study. (2) Receipt of any vaccination (including influenza) within 4 weeks of Baseline (3) History of blood donation within 2 months of Baseline (4) History of anaphylaxis to any LH-RH analogues (5) Receipt of any LHRH suppressive therapy within 6 months of Baseline (6) Major surgery, including any prostatic surgery, within 4 weeks of Baseline (7) History and concomitant clinical and radiographic evidence of central nervous system/spinal cord metastases. Subjects at risk for spinal cord compression will be excluded. (8) Clinical evidence of active urinary tract obstruction and subjects at risk for urinary obstruction (9) History of bilateral orchiectomy, adrenalectomy, or hypophysectomy (10) History or presence of hypogonadism, or receipt of exogenous testosterone supplementation within 6 months of Baseline (11) Clinically significant abnormal ECG and/or history of clinically significant cardiovascular disease as judged by the investigator (12) History of drug and/or alcohol abuse within 6 months of Baseline (13) Contraindication to leuprolide or an LHRH agonist as indicated on package labeling (14) Use of 5-alpha reductase inhibitor within the last 6 months of Baseline (15) History or presence of insulin-dependent diabetes mellitus (Type I). Presence of well controlled diabetes mellitus Type II will be allowed if only oral hypoglycemic are required (16) Use of systemic corticosteroids at a dose >10mg/d or anti-androgens (17) Use of any investigational agent within 4 weeks of Baseline (18) Use of any over-the-counter (OTC) medication within 4 weeks of Baseline except for those listed in the permitted Concomitant Treatment section. (19) Uncontrolled intercurrent illness that would jeopardize the subject’s safety, interfere with the objectives of the protocol, or limit the subject’s compliance with study requirements, as determined by the Investigator in consultation with the Sponsor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: 1. Determine the safety and tolerability of LMIS 50 mg for up to 1 year of exposure following 2 subcutaneous doses given at 6 months apart in subjects with advanced prostate carcinoma; 2. Establish the efficacy of LMIS 50 mg for up to 1 year following 2 subcutaneous doses given at 6 months apart in subjects with advanced prostate carcinoma, as determined by the magnitude and duration of suppression of serum testosterone levels; and 3. Evaluate the pharmacokinetic behavior of serum leuprolide following 2 subcutaneous injections of LMIS 50 mg given 6 months apart.;Secondary Objective: Secondary objectives are to characterize the effects of LMIS 50 mg on the ancillary laboratory markers of serum prostate specific antigen (PSA) and luteinizing hormone (LH).;Primary end point(s): Primary Endpoints 1. Determine the safety and tolerability by: • Change in bone pain measurement (by VAS scale) • Change in urinary pain measurement (by VAS scale) • Change in urinary signs and symptoms (by AUA Symptom Score sheet) • Change in vital signs (BP, HR, RR) • Change in physical examinations (including weight) • Assessment for local skin tolerability • Change in lab data, including liver function (AST, ALT, ALP), renal function (BUN, SCr), complete blood count with platelets, clinical chemistries (K, Na, Mg, Ca and P), urinalysis, serum glucose, lipid profile (LDL, HDL, triglycerides) and HgbA1c • Adverse event (AE) reporting • Clinically significant changes in 12-lead resting electrocardiograms (ECGs) per the Investigator 2. Efficacy evaluation • The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (= 50 ng/dL) within 28 days following the first injection of LMIS 50 mg and the percentage of subjects with serum testosterone suppression (= 50 ng/dL) from Day 28 through Day 336 (remaining duration of the study). 3. Evaluation of pharmacokinetics • Pharmacokinetic behavior of leuprolide: full pharmacokinetic p | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints 1. The proportion of subjects exhibiting post-suppression excursions of serum testosterone to >50 ng/dL, either through “breakthrough” (i.e., episodes unrelated to LMIS 50 mg dosing), or through the “acute-on-chronic” phenomenon (i.e., related to the second dose of LMIS 50 mg) 2. Effect of LMIS 50 mg on serum PSA levels 3. Effect of LMIS 50 mg on serum LH levels;Timepoint(s) of evaluation of this end point: 1. The proportion of subjects exhibiting post-suppression excursions of serum testosterone: Visits 2-23 2. Effect of LMIS 50 mg on serum PSA levels: Visits 2-23 3. Effect of LMIS 50 mg on serum LH levels: Visits 2-23 | — |
Countries
Austria, Czech Republic, Germany, Lithuania, Poland, Slovakia, Taiwan, United States
Contacts
Public ContactClinical Trials Information
QPS Austria
Outcome results
None listed