Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: LMIS 50 mg
Intervention description: Subcutaneous injection of 50 mg Leuprolide Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Neoplasm Cancer Carcinoma; Safety Extension

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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.

          2. 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

          3. Agree to use male contraceptive methods during study trial

          4. 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

          5. 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:

          1. 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.

          2. 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

          3. Subject has used prohibited treatments as listed in the Section 8.2 during
             participation in Protocol FP01C-13-001.

          4. 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

          5. Investigator considers that it is no longer feasible for the subject to be included in
             a study of LMIS 50 mg

          6. Subjects with persistent, non-castrate testosterone levels judged by the investigator

          7. 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