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

NCT ID: NCT02234115

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 137 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-01-05

Brief 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.

Detailed 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.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Leuprolide Mesylate 50mg

All subjects will be males with advanced prostate carcinoma. They will be injected twice with a depot formulation containing 50 mg of Leuprolide Mesylate. The first dose on day 0 the second dose on day 168 (six months apart). Subjects will be followed until day 336.

Group Type: EXPERIMENTAL

Leuprolide Mesylate

Intervention Type: DRUG

Subcutaneous injection of 50mg Leuprolide Mesylate

Interventions

Leuprolide Mesylate

Subcutaneous injection of 50mg Leuprolide Mesylate

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Foresee Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Mao, PhD

Role: STUDY_DIRECTOR

Foresee Pharmaceuticals Co., Ltd.

Locations

Urology Centers of Alabama

Homewood, Alabama, United States

Alliance Research Centers

Laguna Hills, California, United States

Genesis Research, LLC

San Diego, California, United States

Idaho Urologic Institute - Meridian

Meridian, Idaho, United States

AdvanceMed Research

Lawrenceville, New Jersey, United States

Carolina Clinical Trials, LLC

Concord, North Carolina, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Seattle Urology Research Center

Burien, Washington, United States

AKH Linz GmbH, Department of Urology

Linz, Upper Austria, Austria

Universitätsklinik für Urologie und Andrologie, Landeskrankenhaus Salzburg (University hospital for Urology and Andrology)

Salzburg, , Austria

Thomayerova nemocnice Urologické oddělení

Prague, Praha 4 - Krč, Czechia

University Hospital Hradec Králové

Hradec Králové, , Czechia

University Hospital Olomouc

Olomouc, , Czechia

Universitätsklinikum RWTH Aachen, Klinik für Urologie

Aachen, North Rhine-Westphalia, Germany

PI Hospital of Lithuanian University of Health Sciences, Kauno Klinikos

Kaunas, , Lithuania

PI Klaipėda University Hospital

Klaipėda, , Lithuania

PI Vilnius University Hospital, Santariškių Klinikos

Vilnius, , Lithuania

Centralny Szpital Kliniczny MSW w Warszawie, Klinika Urologii i Urologii Onkologicznej

Warzawa, Warzawa, Poland

Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Układu Moczowego

Warzawa, Warzawa, Poland

Uniwersyteckie Centrum Kliniczne, Klinika Urologii

Gdansk, , Poland

"DERMED" Centrum Medyczne Sp. z o.o.

Lodz, , Poland

UROCENTRUM MILAB, s.r.o.

Prešov, , Slovakia

Fakultná nemocnica s poliklinikou Žilina Urológia

Žilina, , Slovakia

Kaohsiung Veteran General Hospital (VGHKS)

Kaohsiung City, Pingtung, Taiwan

China Medical University Hospital (CMUH)

Taichung, Taichung, Taiwan

Taichung Veteran General Hospital (VGHTC)

Taichung, 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, , Taiwan

Countries

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

Other Identifiers

2013-001790-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

FP01C-13-001

Identifier Type: -

Identifier Source: org_study_id