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Carcinoma

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

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Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

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All Drugs and Chemicals

Leuprolide

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)

Subcutaneous injection of 50 mg Leuprolide Mesylate

LMIS 50 mg

John Mao, Ph.D.

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.

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.

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

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

Evaluate the incidence of adverse events, drug-related adverse events, and serious adverse events

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.

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.

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.

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.

QPS-Qualitix

Foresee Pharmaceuticals Co., Ltd.

All subjects were males with advanced prostate carcinoma. They were injected 2 doses of LMIS 50 mg with approximately 6 months (24-week) apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)

LMIS 50 mg: Subcutaneous injection of 50 mg Leuprolide Mesylate

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Dr. John Mao

TEAE

Drug-related AE

Serious Adverse Event (SAE)

Number of Participants With Adverse Events

Overall Interpretation at Screening (V1)

Overall Interpretation on Day 168 (V4)

Overall Interpretation on Day 336 (V6/EOS)

8 subjects did not receive the second dose due to drug supply expiration, and 4 subjects due to early termination. Hence, only 18 subjects entered Day 168 (V4). 3 subjects were unable or unwilling to return on Day 336 (V6/EOS) due to early termination.

Evaluate the Effect of LMIS 50 mg on Cardiovascular Function

Hemoglobin (gm/dL) at Screening (V1)

Hemoglobin (gm/dL) on Day 168 (V4)

Hemoglobin (gm/dL) on Day 336 (V6/EOS)

Hematocrit (%) at Screening (V1)

Hematocrit (%) on Day 168 (V4)

Hematocrit (%) on Day 336 (V6/EOS)

RBC (x10.e6/uL) at Screening (V1)

RBC (x10.e6/uL) on Day 168 (V4)

RBC (x10.e6/uL) on Day 336 (V6/EOS)

WBC (x10.e3/uL) at Screening (V1)

WBC (x10.e3/uL) on Day 168 (V4)

WBC (x10.e3/uL) on Day 336 (V6/EOS)

Platelets (x10.e3/uL) at Screening (V1)

Platelets (x10.e3/uL) on Day 168 (V4)

Platelets (x10.e3/uL) on Day 336 (V6/EOS)

Neutrophils(%) at Screening (V1)

Neutrophils(%) on Day 168 (V4)

Neutrophils(%) on Day 336 (V6/EOS)

Eosinophils(%) at Screening (V1)

Eosinophils(%) on Day 168 (V4)

Eosinophils(%) on Day 336 (V6/EOS)

Basophils (%) at Screening (V1)

Basophils (%) on Day 168 (V4)

Basophils (%) on Day 336 (V6/EOS)

Lymphocytes (%) at Screening (V1)

Lymphocytes (%) on Day 168 (V4)

Lymphocytes (%) on Day 336 (V6/EOS)

Monocytes (%) at Screening (V1)

Monocytes (%) on Day 168 (V4)

Monocytes (%) on Day 336 (V6/EOS)

HgbA1c (%) at Screening (V1)

HgbA1c (%) on Day 336 (V6/EOS)

Laboratory Assessments - Hematology

ALT (U/L) at Screening (V1)

ALT (U/L) on Day 168 (V4)

ALT (U/L) on Day 336 (V6/EOS)

AST (U/L) at Screening (V1)

AST (U/L) on Day 168 (V4)

AST (U/L) on Day 336 (V6/EOS)

ALP (U/L) at Screening (V1)

ALP (U/L) on Day 168 (V4)

ALP (U/L) on Day 336 (V6/EOS)

Total bilirubin(mg/dL) at Screening (V1)

Total bilirubin(mg/dL) on Day 168 (V4)

Total bilirubin(mg/dL) on Day 336 (V6/EOS)

BUN (mg/dL) at Screening (V1)

BUN (mg/dL) on Day 168 (V4)

BUN (mg/dL) on Day 336 (V6/EOS)

Serum Cr. (mg/dL) at Screening (V1)

Serum Cr. (mg/dL) on Day 168 (V4)

Serum Cr. (mg/dL) on Day 336 (V6/EOS)

Potassium (mEq/L) at Screening (V1)

Potassium (mEq/L) on Day 168 (V4)

Potassium (mEq/L) on Day 336 (V6/EOS)

Sodium (mEq/L) at Screening (V1)

Sodium (mEq/L) on Day 168 (V4)

Sodium (mEq/L) on Day 336 (V6/EOS)

Magnesium (mg/dL) at Screening (V1)

Magnesium (mg/dL) on Day 168 (V4)

Magnesium (mg/dL) on Day 336 (V6/EOS)

Calcium (mg/dL) at Screening (V1)

Calcium (mg/dL) on Day 168 (V4)

Calcium (mg/dL) on Day 336 (V6/EOS)

Phosphorus (mg/dL) at Screening (V1)

Phosphorus (mg/dL) on Day 168 (V4)

Phosphorus (mg/dL) on Day 336 (V6/EOS)

Blood glucose (mg/dL) at Screening (V1)

Blood glucose (mg/dL) on Day 168 (V4)

Blood glucose (mg/dL) on Day 336 (V6/EOS)

LDL (mg/dL) at Screening (V1)

LDL (mg/dL) on Day 168 (V4)

LDL (mg/dL) on Day 336 (V6/EOS)

HDL (mg/dL) at Screening (V1)

HDL (mg/dL) on Day 168 (V4)

HDL (mg/dL) on Day 336 (V6/EOS)

Triglycerides(mg/dL) at Screening (V1)

Triglycerides(mg/dL) on Day 168 (V4)

Triglycerides(mg/dL) on Day 336 (V6/EOS)

Laboratory Assessments - Biochemistry

pH at Screening (V1)

pH on Day 168 (V4)

pH on Day 336 (V6/EOS)

Specific gravity at Screening (V1)

Specific gravity on Day 168 (V4)

Specific gravity on Day 336 (V6/EOS)

Leukocyte at Screening (V1)

Leukocyte on Day 168 (V4)

Leukocyte on Day 336 (V6/EOS)

Erythrocyte at Screening (V1)

Erythrocyte on Day 168 (V4)

Erythrocyte on Day 336 (V6/EOS)

Protein at Screening (V1)

Protein on Day 168 (V4)

Protein on Day 336 (V6/EOS)

Laboratory Assessments - Urinalysis

Overall Study

Spots Global Cancer Trial Database for safety extension