Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate in Subjects With Advanced Prostate Carcinoma

Prostatic Neoplasms Clinical Trial

Official title:

An Open-Labeled, Singled-Arm Study of the Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate for Injectable Suspension (LMIS 50 mg) in Subjects With Advanced Prostate Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02234115
• Other study ID #: FP01C-13-001
• Secondary ID: 2013-001790-25
• Status: Completed
• Phase: Phase 3
• Start date: August 2014
• Est. completion date: January 5, 2017

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 advanced prostate carcinoma, when administered as two injections six months apart.

Description:

This is a multi-center, open-label, single-arm study conducted in 2 parts. Part I was established to provide a vanguard of the first 30 subjects who will have more frequent monitoring of their safety. If safety is established, the remainder of the subjects will be entered into the clinical study (i.e., Part II). All subjects will be males with advanced prostate carcinoma judged to be candidates for medical androgen ablation therapy, and all will receive two injections of LMIS 50 mg six-month apart in an unblinded fashion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: January 5, 2017
• Est. primary completion date: August 30, 2016
• 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 judgment

• HgbA1c within acceptable range according to investigator's judgment

• 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:

• 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.

• Receipt of any vaccination (including influenza) within 4 weeks of Baseline

• History of blood donation within 2 months of Baseline

• History of anaphylaxis to any LH-RH analogues

• Receipt of any LHRH suppressive therapy within 6 months of Baseline

• Major surgery, including any prostatic surgery, within 4 weeks of Baseline

• History and concomitant clinical and radiographic evidence of central nervous system/spinal cord metastases. Subjects at risk for spinal cord compression will be excluded.

• Clinical evidence of active urinary tract obstruction and subjects at risk for urinary obstruction

• History of bilateral orchiectomy, adrenalectomy, or hypophysectomy

• History or presence of hypogonadism, or receipt of exogenous testosterone supplementation within 6 months of Baseline

• Clinically significant abnormal ECG and/or history of clinically significant cardiovascular disease as judged by the investigator

• History of drug and/or alcohol abuse within 6 months of Baseline

• Contraindication to leuprolide or an LHRH agonist as indicated on package labeling

• Use of 5-alpha reductase inhibitor within the last 6 months of Baseline

• History or presence of insulin-dependent diabetes mellitus (Type I). Presence of well controlled diabetes mellitus Type II will be allowed

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

• Use of any investigational agent within 4 weeks of Baseline

• Use of any over-the-counter (OTC) medication within 4 weeks of Baseline except for those listed in the permitted Concomitant Treatment section.

• 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

• Carcinoma
• Prostatic Neoplasms

Intervention

Drug:
• Leuprolide Mesylate
Subcutaneous injection of 50mg Leuprolide Mesylate

Locations

Country	Name	City	State
Austria	AKH Linz GmbH, Department of Urology	Linz	Oberösterreich
Austria	Universitätsklinik für Urologie und Andrologie, Landeskrankenhaus Salzburg (University hospital for Urology and Andrology)	Salzburg
Czechia	University Hospital Hradec Králové	Hradec Králové
Czechia	University Hospital Olomouc	Olomouc
Czechia	Thomayerova nemocnice Urologické oddelení	Praha	Praha 4 - Krc
Germany	Universitätsklinikum RWTH Aachen, Klinik für Urologie	Aachen	Nordrhein-Westfalen
Lithuania	PI Hospital of Lithuanian University of Health Sciences, Kauno Klinikos	Kaunas
Lithuania	PI Klaipeda University Hospital	Klaipeda
Lithuania	PI Vilnius University Hospital, Santariškiu Klinikos	Vilnius
Poland	Uniwersyteckie Centrum Kliniczne, Klinika Urologii	Gdansk
Poland	"DERMED" Centrum Medyczne Sp. z o.o.	Lódz
Poland	Centralny Szpital Kliniczny MSW w Warszawie, Klinika Urologii i Urologii Onkologicznej	Warzawa
Poland	Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Nowotworów Ukladu Moczowego	Warzawa
Slovakia	Fakultná nemocnica s poliklinikou Žilina Urológia	Žilina
Slovakia	UROCENTRUM MILAB, s.r.o.	Prešov
Taiwan	Kaohsiung Veteran General Hospital (VGHKS)	Kaohsiung City	Pingtung
Taiwan	China Medical University Hospital (CMUH)	Taichung City	Taichung
Taiwan	Taichung Veteran General Hospital (VGHTC)	Taichung City	Taichung
Taiwan	National Cheng Kung University Hospital (NCKUH)	Tainan City	Tainan
Taiwan	National Taiwan University Hospital (NTUH)	Taipei City	Taipei
Taiwan	Chang Gung Memorial Hospital, LinKou (CGMH-LK)	Taoyuan City
United States	Seattle Urology Research Center	Burien	Washington
United States	Carolina Clinical Trials, LLC	Concord	North Carolina
United States	Urology Centers of Alabama	Homewood	Alabama
United States	Alliance Research Centers	Laguna Hills	California
United States	AdvanceMed Research	Lawrenceville	New Jersey
United States	Idaho Urologic Institute - Meridian	Meridian	Idaho
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Genesis Research, LLC	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Foresee Pharmaceuticals Co., Ltd.

Countries where clinical trial is conducted

United States,  Austria,  Czechia,  Germany,  Lithuania,  Poland,  Slovakia,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of Leuprolide Mesylate (LMIS 50mg)	The percentage of subjects with a serum testosterone concentration suppressed to castrate levels (= 50 ng/dL) following the first injection of LMIS 50 mg from Day 28 through Day 336 (remaining duration of the study).	baseline to 28 days, 28 days to 336 days
Secondary	Number of Participants With Adverse Events (AEs)	Safety analysis was based on the safety information from the laboratory evaluations, AEs, and SAEs.	336 days