Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer

Prostatic Neoplasms Clinical Trial

Official title:

An Open-Label, Single-Arm Study of The Efficacy, Safety, and Pharmacokinetic Behavior of Leuprolide Mesylate Injectable Suspension (LMIS 25 mg) in Subjects With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03261999
• Other study ID #: FP01C-17-001
• Secondary ID: 2017-001333-88
• Status: Completed
• Phase: Phase 3
• Start date: September 26, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: February 2019
• Source: Foresee Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will evaluate if Leuprolide Mesylate is safe and effective in the treatment of subjects with prostate cancer, when administered as two injections twelve weeks apart.

Description:

This is a multi-national, multi-center, open-label, single-arm study. All subjects will be males with prostate cancer judged to be candidates for medical androgen ablation therapy and all will receive two injections of LMIS 25 mg twelve-week apart in an unblinded fashion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: February 1, 2019
• Est. primary completion date: November 19, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 performed at Screening Visit

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 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

• Serum glucose within acceptable range according to investigator's judgement

• Urinalysis within normal range according to the investigator's judgment

8. Agree to use male contraceptive methods during study trial

9. Based on the Investigator's judgment, 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:

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 screening visit

3. History of blood donation within 2 months of screening visit

4. History of anaphylaxis to any LH-RH analogues

5. Receipt of any LHRH suppressive therapy within 6 months of screening visit

6. Major surgery, including any prostatic surgery, within 4 weeks of screening visit

7. History and concomitant clinical and radiographic evidence of central nervous system/spinal cord metastases and 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 screening visit

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. Prostate cancer subjects with poor controlled diabetes mellitus with Hb1Ac > 9.5% or urine glycosuria > 1.0 g/dL should be excluded.

16. Use of systemic corticosteroids at a dose >10 mg/d or anti-androgens

17. Use of any investigational agent within 4 weeks of screening visit

18. Use of any over-the-counter (OTC) medication within 4 weeks of screening visit 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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Leuprolide Mesylate
Subcutaneous injection of 25mg Leuprolide Mesylate

Locations

Country	Name	City	State
Czechia	Fakultní nemocnice Hradec Králové, Urologická klinika	Hradec Králové
Czechia	Uromedical Center Olomouc	Olomouc
Czechia	Thomayerova nemocnice, Urologické oddelení	Praha
Korea, Republic of	Pusan National University Hospital	Busan
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Hallym University Sacred Heart Hospital	Gyeonggi-do
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hosptal	Gyeonggi-do
Korea, Republic of	Korea University Anam Hospital	Seoul
Lithuania	Hospital of Lithuanian University of Health Sciences Kauno klinikos	Kaunas
Lithuania	Klaipeda University Hospital	Klaipeda
Lithuania	National Cancer Institute	Vilnius
Lithuania	Vilnius University Hospital, Santaros klinikos	Vilnius
Slovakia	Fakultná nemocnica s poliklinikou Žilina Urológia	Žilina
Slovakia	UROCENTRUM MILAB, s.r.o.	Prešov
United States	Carolina Clinical Trials, LLC	Concord	North Carolina
United States	The Urology Center of Colorado	Denver	Colorado
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Urology San Antonio, P.A	San Antonio	Texas
United States	Arizona Institute of Urology	Tucson	Arizona
United States	Urology of Virginia, PLLC	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Foresee Pharmaceuticals Co., Ltd.

Countries where clinical trial is conducted

United States,  Czechia,  Korea, Republic of,  Lithuania,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Leuprolide Mesylate (LMIS 25mg)	The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (= 50 ng/dL) from Day 28 through Day 168.	168 days
Secondary	Number of Participants With Adverse Events	Determining the safety and tolerability of LMIS 25 mg based on adverse events (AEs).	168 days