Clinical Trials List
Protocol NumberFP01C-13-001
2014-08-01 - 2016-12-31
Phase III
Terminated6
ICD-10C61
Malignant neoplasm of prostate
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9185
Malignant neoplasm of prostate
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
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Trial Applicant
QPS
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Sponsor
Foreseeacer Pharmaceuticals, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- SHUO-MENG WANG Division of Urology
- Hong-Chiang Chang Division of Urology
- Yu-Chieh Tsai Division of Hematology & Oncology
- 劉詩彬 Division of Urology
- CHUNG-HSIN CHEN Division of Urology
- Yeong-Shiau Pu Division of Urology
- 戴槐青 Division of Urology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- PO-HUNG LIN Division of Hematology & Oncology
- 張英勛 Division of Hematology & Oncology
- 林柏宏 Division of Hematology & Oncology
- See-Tong Pang Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 蔡宗欣 Division of Hematology & Oncology
- Wen-Horng Yang Division of Urology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Cheng-Kuang Yang Division of Urology
- Chuan-Shu Chen Division of Urology
- Shian-Shiang Wang Division of Urology
- Jian-Ri Li Division of Urology
- 洪啟峰 Division of Urology
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chao-Hsiang Chang Division of Urology
- Chin-Chung Yeh Division of Urology
- Chi-Ping Huang Division of Urology
- Wen-Chi Chen Division of Urology
- Hsi-Chin Wu Division of Urology
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Advanced Prostate Carcinoma
Objectives
primary objectives:
‧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；
‧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
‧Evaluate the pharmacokinetic behavior of serum leuprolide following 2 subcutaneous injections of LMIS 50 mg given 6 months apart.
Secondary objective:
‧To characterize the effects of LMIS 50 mg on the ancillary laboratory markers of serum prostate specific antigen (PSA) and luteinizing hormone (LH).
Test Drug
LMIS
Active Ingredient
Leuprolide Mesylate
Dosage Form
Injection
Dosage
50
Endpoints
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) by Day 28 ± 1(day) 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 profiles from serum leuprolide concentrations in Part I subjects will be per formed. Additional serum leuprolide concentration data will be collected during Part II. The pharmacokinetic behavior of leuprolide will be determined on a more limited basis for subjects in Part II.
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
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) by Day 28 ± 1(day) 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 profiles from serum leuprolide concentrations in Part I subjects will be per formed. Additional serum leuprolide concentration data will be collected during Part II. The pharmacokinetic behavior of leuprolide will be determined on a more limited basis for subjects in Part II.
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
Inclution Criteria
Main 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) Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 2
(6) Life expectancy of at least 18 months
(7) 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)
- AST (SGOT) ≤ 2.5 × ULN
- ALT (SGPT) ≤ 2.5 × ULN
- Serum creatinine ≤ 1.5 mg/dL
- Lipid profile within normal range
- Serum glucose within normal range
- HgbA1c within normal range
- Clinical chemistries (K, Na, Mg, Ca and P) within normal range
- Urinalysis within normal range according to the investigator
(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.
(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) Eastern Cooperative Oncology Group (ECOG) Performance score ≤ 2
(6) Life expectancy of at least 18 months
(7) 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)
- AST (SGOT) ≤ 2.5 × ULN
- ALT (SGPT) ≤ 2.5 × ULN
- Serum creatinine ≤ 1.5 mg/dL
- Lipid profile within normal range
- Serum glucose within normal range
- HgbA1c within normal range
- Clinical chemistries (K, Na, Mg, Ca and P) within normal range
- Urinalysis within normal range according to the investigator
(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.
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.
(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 c oncomitant clinical and radiographic evidence of central nervous system/spinal cord metastases. Subjects at risk for spinal cord compression.
(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 >10 mg/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.
(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.
(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 c oncomitant clinical and radiographic evidence of central nervous system/spinal cord metastases. Subjects at risk for spinal cord compression.
(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 >10 mg/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.
The Estimated Number of Participants
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Taiwan
36 participants
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Global
133 participants
