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

Information source: Foreseeacer Pharmaceuticals, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prostatic Neoplasms

Intervention: Leuprolide Mesylate (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Foreseeacer Pharmaceuticals, Inc.

Official(s) and/or principal investigator(s):
John Mao, PhD, Study Director, Affiliation: Foreseeacer Pharmaceuticals, Inc.

Overall contact:
John Mao, PhD, Phone: 650-421-1016, Email: john.mao@foreseepharma.com

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.

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy of Leuprolide Mesylate (LMIS 50mg)

Secondary outcome:

Post-suppression excursions of serum testosterone

Pharmacokinetics of Leuprolide Mesylate (LMIS 50mg)

Safety and tolerability of LMIS 50 mg

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Males aged ≥18 years old

- Males with histologically confirmed carcinoma of the prostate

- Subjects who are judged by the attending physician and/or Principal Investigator to

be a candidate for androgen ablation therapy

- Baseline morning serum testosterone level >150 ng/dL

- Eastern Cooperative Oncology Group (ECOG)Performance score ≤ 2

- Life expectancy of at least 18 months

- 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 opinion

- Urinalysis within normal range according to the investigator's opinion

- Agree to use male contraceptive methods during study trial

- 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 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

Foreseeacer Pharmaceuticals, Inc. Protocol No.: FP01C-13-001 Confidential Version: 1. 2 Date: 07-Aug-2014 Page 28/82

- 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

Locations and Contacts

John Mao, PhD, Phone: 650-421-1016, Email: john.mao@foreseepharma.com

Universitätsklinik für Urologie und Andrologie, Landeskrankenhaus Salzburg (University hospital for Urology and Andrology), Salzburg 5020, Austria; Not yet recruiting
Dagmar Häusler, Phone: +43(0)662 4482-2970, Email: d.haeusler@salk.at
Stephen Hruby, MD, Principal Investigator
Tobias Schätz, MD, Principal Investigator

Fakultní nemocnice Hradec Králové Urologická klinika, Hradec Králové 500 05, Czech Republic; Not yet recruiting
Taťána Hanzlíčková, Phone: +420 495 833 378, Email: tatana.hanzlickova@fnhk.cz
Miloš Broďák, MD, Principal Investigator
Lukáš Holub, MD, Principal Investigator

Fakultní nemocnice Olomouc Urologická klinika, Olomouc 779 00, Czech Republic; Not yet recruiting
Karla Krejčiříková, Phone: +420 588 442 670, Email: kajakrejca@seznam.cz
Vladimir Student, MD, Principal Investigator

"Fakultná nemocnica s poliklinikou Žilina Urológia ", Žilina 012 07, Slovakia; Not yet recruiting
Edita Soláriková, Phone: +421 907 242 696, Email: edita.solarikova@gmail.com
Juraj Mikuláš, MD, Principal Investigator
Peter Laurinc, MD, Sub-Investigator

Urology Centers of Alabama, Homewood, Alabama 35209, United States; Recruiting
Tosha Pringle, Phone: 205-414-4423, Email: tpringle@urologyal.com
George Adams, MD, Principal Investigator

Alliance Research Centers, Laguna Hills, California 92653, United States; Recruiting
Zena Kahn, Phone: 949-680-3490, Email: zkhan@researchalliance.com
Aron Spitz, MD, Principal Investigator

Genesis Research, LLC, SanDiego, California 92123, United States; Recruiting
Maria Numez, Phone: 858-429-7050, Email: mnunez@genhp.com
William Moseley, MD, Principal Investigator

Idaho Urologic Institute - Meridian, Meridian, Idaho 83642, United States; Recruiting
Shanna Vail, Phone: 208-639-4938, Email: svail@idurology.com
Joseph William, MD, Principal Investigator

AdvanceMed Research, Lawrenceville, New Jersey 08648, United States; Recruiting
Melisssa Clatteo, Phone: 609-895-0735, Ext: 136, Email: mlciatteo@advancemed.info
Russell Freid, MD, Principal Investigator

Medizinische Hochschule Hannover, Clinic for Urology and Urological Onkology, Hanover, Niedersachsen 30625, Germany; Not yet recruiting
Nadja Bergen, Phone: +49 511-532 5847, Email: Bergen.nadja@mh-hannover.de
Axel Mereseburger, MD, Principal Investigator
Mario Kramer, MD, Sub-Investigator

Universitätsklinikum RWTH Aachen, Klinik für Urologie, Aachen, Nordrhein-Westfalen 52074, Germany; Not yet recruiting
Marianne Reinartz, Phone: + 49 (0) 241 80-80455, Email: mreinartz@ukaachen.de
Axel Heidenreich, MD, Principal Investigator
David Pfister, MD, Principal Investigator

Carolina Clinical Trials, LLC, Concord, North Carolina 28025, United States; Recruiting
Jennie Bridges, Phone: 704-786-2931, Email: jbridges@carolinaclinicaltrials.com
David Lipsitz, MD, Principal Investigator

AKH Linz GmbH, Department of Urology, Linz, Oberösterreich 4020, Austria; Not yet recruiting
Andrea Pröll, Phone: 43 732-7806 78227, Email: andrea.proell@akh.linz.at
Steffen Krause, MD, Principal Investigator
Tauber Volkman, MD, Sub-Investigator

Kaohsiung Veteran General Hospital (VGHKS), Kaohsiung City, Pingtung 813, Taiwan; Not yet recruiting
Hsin-Tien Tsai, Phone: 886-7-342-2121, Ext: 3016, Email: hsintien.tsai@gmail.com
Dong-Lin Wu, MD, Principal Investigator

Thomayerova nemocnice Urologické oddělení, Praha, Praha 4 - Krč 140 59, Czech Republic; Not yet recruiting
Roman Zachoval, MD, Phone: +420 261 083 819, Email: roman.zachoval@ftn.cz
Roman Zachoval MD Zachoval, MD, Principal Investigator
Jaroslav Jarabák, MD, Sub-Investigator

Carolina Urologic Research Center, Myrtle Beach, South Carolina 29572, United States; Not yet recruiting
Stacey Harrelson, Phone: 843-449-1010, Ext: 268, Email: sharrelson@atlanticurologyclinics.com
Neal Shore, MD, Principal Investigator

China Medical University Hospital (CMUH), Taichung City, Taichung 404, Taiwan; Not yet recruiting
Yen-Chen Hsiao, Phone: 886-4-2205-2121, Ext: 4440, Email: elvater1771@yahoo.com.tw
Chi-Rei Yang, MD, Principal Investigator

Taichung Veteran General Hospital (VGHTC), Taichung City, Taichung 407, Taiwan; Not yet recruiting
Tzu-Shuan Jaun, Phone: 886-7-342-2121, Ext: 3002, Email: tonywu@vghks.gov.tw
Yen-Chuan Ou, MD, Principal Investigator

National Cheng Kung University Hospital (NCKUH), Tainan City, Tainan 704, Taiwan; Not yet recruiting
Rita Cheng, Email: qq0982700615@hotmail.com
Yuh-Shyan Tasi, MD, Principal Investigator

National Taiwan University Hospital (NTUH), Taipei City, Taipei 100, Taiwan; Not yet recruiting
Minnie Deng, Phone: 886-2-2312-3456, Ext: 65238, Email: minniedeng1025@gmail.com
Chao-Yuan Huang, MD, Principal Investigator

Chang Gung Memorial Hospital, LinKou (CGMH-LK), Guishan Township, Taoyuan County 333, Taiwan; Not yet recruiting
Cheng-Keng Chuang, Phone: 886-3-328-1200, Ext: 2453, Email: chuang89@cgmh.org.tw
Cheng-Keng Chuang, MD, Principal Investigator

Seattle Urology Research Center, Burien, Washington 98166, United States; Recruiting
Angela Felipa, Phone: 206-243-3701, Email: surc@comcast.net
Jeffery Frankel, MD, Principal Investigator

Additional Information

Starting date: August 2014
Last updated: September 4, 2014

Page last updated: August 23, 2015

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