Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg

Study Overview
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Brief Summary
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This is a safety extension of up to 12 months of additional treatment with LMIS 50 mg after the subject has completed 12 months of treatment under Protocol FP01C-13-001 and remain eligible for continued treatment with androgen deprivation therapy. Subjects participating in Protocol FP01C-13-001-EX will be followed for safety only.

Detailed Description
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This is a multi-center, open-label, single-arm safety extension study. After completing 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 (with last dose under Protocol FP01C-13-001 approximately 6 months prior to Day 0 or Protocol FP01C-13-001-EX) and providing a written informed consent, subjects will be screened against baseline inclusion/exclusion criteria necessary for study eligibility. Eligible subjects will receive LMIS 50 mg from the prefilled syringes (without dilution or other mixing) in up to two single subcutaneous injections given 6 months apart.

Official Title
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An Open-Label, Single-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma - SAFETY EXTENSION

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: LMIS 50 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Complete 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001. If a subject wishes to enter the Extension study after more than 28 days following his end of study visit for Protocol FP01C-13-001, his serum testosterone level should be repeated at the screening visit to confirm that his castrate-level testosterone has been maintained. Laboratory values Absolute neutrophil count ≥ 1,500 cells/µL Platelets≥100,000 cells/µL Hemoglobin ≥ 10 gm/dL Total bilirubin ≤ 1.5 × upper limit of normal (ULN) Aspartate Transaminase (AST/SGOT) ≤ 2.5 × ULN Alanine Aminotransferase (ALT/SGPT) ≤ 2.5 × ULN Serum creatinine ≤ 1.5 mg/dL Lipid profile within acceptable range according to investigator's opinion Serum glucose within acceptable range according to investigator's opinion HgbA1c within acceptable range according to investigator's opinion Clinical chemistries (K, Na, Mg, Ca and P) within acceptable range according to investigator's judgment Urinalysis within normal range according to the investigator's judgment Agree to use male contraceptive methods during study trial 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 All aspects of the protocol explained and written informed consent obtained *If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days prior to entering the Extension study, the Eastern Cooperative Oncology Group (ECOG), Physical Examination (PE), ECG, laboratory and Prostate Specific Antigen (PSA) tests should be repeated. If the patient has completed 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 within the last 28 days, they will be allowed to enter the Extension study without repeating the testosterone measurements, ECG, PE, laboratory and the PSA tests Exclusion Criteria: Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti-androgen therapy other than LMIS 50 mg under Protocol FP01C-13-001 for treatment of carcinoma of the prostate during the subject's participation in Protocol FP01C-13-001. Radiation for pain control will be allowed during the study. Receipt of any Luteinizing Hormone-releasing Hormone (LHRH) suppressive therapy within 6 months of Screening Visit other than LMIS 50 mg under Protocol FP01C-13-001 Subject has used prohibited treatments as listed in the Section 8.2 during participation in Protocol FP01C-13-001. Any pathological event, clinical adverse event, or any change in the subject's status at the end of FP01C-13-001 giving indication to the investigator that further participation in the study may not be the best interest of the subject Investigator considers that it is no longer feasible for the subject to be included in a study of LMIS 50 mg Subjects with persistent, non-castrate testosterone levels judged by the investigator 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LMIS 50 mg<br>50 mg leuprolide mesylate administered subcutaneously, when given as two separate injections 6 months apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001) | Drug: LMIS 50 mg<br>* Subcutaneous injection of 50 mg Leuprolide Mesylate<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | Evaluate the incidence of adverse events, drug-related adverse events, and serious adverse events | Up to 48 weeks | 
| Evaluate the Effect of LMIS 50 mg on Cardiovascular Function | Use 12-lead resting electrocardiograms (ECGs) to evaluate the effect of LMIS 50 mg on cardiovascular function, such as heart rate, RR interval, QRS complex, PR interval, and QT interval. | Up to 48 weeks | 
| Laboratory Assessments - Hematology | Hematology assessments performed in this study included hemoglobin, hematocrit, Red Blood Cell (RBC), White Blood Cell (WBC), platelets, neutrophil, eosinophil, basophil, lymphocyte, monocyte, and HbA1c. | 48 weeks | 
| Laboratory Assessments - Biochemistry | Biochemical assessments performed in this study included Alanine Aminotransferase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), total bilirubin, Blood Urea Nitrogen (BUN), serum Cr, potassium, sodium, magnesium, calcium, phosphorus, blood glucose, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and triglycerides. | 48 weeks | 
| Laboratory Assessments - Urinalysis | Urinalysis was performed to assess the safety profile of LMIS 50 mg during the study period, including pH, specific gravity, and the presences of leukocytes, erythrocytes, or protein. | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Neoplasm Cancer Carcinoma, Safety Extension