Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg

NCT02712320 | Completed Phase 3 Results FDA Drug

• 1 other identifier: FP01C-13-001-EX
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief Summary

This is a safety extension of up to 12 months of additional treatment with LMIS 50 mg after the subject has completed 12 months of treatment under Protocol FP01C-13-001 and remain eligible for continued treatment with androgen deprivation therapy. Subjects participating in Protocol FP01C-13-001-EX will be followed for safety only.

Conditions

Prostatic Neoplasms

Keywords

Prostate Neoplasm Cancer Carcinoma; Safety Extension

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Adverse Events

  Evaluate the incidence of adverse events, drug-related adverse events, and serious adverse events

  Up to 48 weeks

• Evaluate the Effect of LMIS 50 mg on Cardiovascular Function

  Use 12-lead resting electrocardiograms (ECGs) to evaluate the effect of LMIS 50 mg on cardiovascular function, such as heart rate, RR interval, QRS complex, PR interval, and QT interval.

  Up to 48 weeks

• Laboratory Assessments - Hematology

  Hematology assessments performed in this study included hemoglobin, hematocrit, Red Blood Cell (RBC), White Blood Cell (WBC), platelets, neutrophil, eosinophil, basophil, lymphocyte, monocyte, and HbA1c.

  48 weeks

• Laboratory Assessments - Biochemistry

  Biochemical assessments performed in this study included Alanine Aminotransferase (ALT), Aspartate Transaminase (AST), Alkaline Phosphatase (ALP), total bilirubin, Blood Urea Nitrogen (BUN), serum Cr, potassium, sodium, magnesium, calcium, phosphorus, blood glucose, Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and triglycerides.

  48 weeks

• Laboratory Assessments - Urinalysis

  Urinalysis was performed to assess the safety profile of LMIS 50 mg during the study period, including pH, specific gravity, and the presences of leukocytes, erythrocytes, or protein.

  48 weeks

Study Arms (1)

LMIS 50 mg

EXPERIMENTAL

50 mg leuprolide mesylate administered subcutaneously, when given as two separate injections 6 months apart (Month 12 and Month 18 from the initiation of Protocol FP01C-13-001)

Drug: LMIS 50 mg

Interventions

LMIS 50 mg DRUG

Subcutaneous injection of 50 mg Leuprolide Mesylate

LMIS 50 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Complete 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001. If a subject wishes to enter the Extension study after more than 28 days following his end of study visit for Protocol FP01C-13-001, his serum testosterone level should be repeated at the screening visit to confirm that his castrate-level testosterone has been maintained.
• 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)
• Aspartate Transaminase (AST/SGOT) ≤ 2.5 × ULN
• Alanine Aminotransferase (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
• Urinalysis within normal range according to the investigator's judgment
• Agree to use male contraceptive methods during study trial

You may not qualify if:

• Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti-androgen therapy other than LMIS 50 mg under Protocol FP01C-13-001 for treatment of carcinoma of the prostate during the subject's participation in Protocol FP01C-13-001. Radiation for pain control will be allowed during the study.
• Receipt of any Luteinizing Hormone-releasing Hormone (LHRH) suppressive therapy within 6 months of Screening Visit other than LMIS 50 mg under Protocol FP01C-13-001
• Subject has used prohibited treatments as listed in the Section 8.2 during participation in Protocol FP01C-13-001.
• Any pathological event, clinical adverse event, or any change in the subject's status at the end of FP01C-13-001 giving indication to the investigator that further participation in the study may not be the best interest of the subject
• Investigator considers that it is no longer feasible for the subject to be included in a study of LMIS 50 mg
• Subjects with persistent, non-castrate testosterone levels judged by the investigator
• 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

Sponsors & Collaborators

• Foresee Pharmaceuticals Co., Ltd.: lead
• QPS-Qualitix: collaborator

Study Sites (7)

Urology Centers of Alabama

Homewood, Alabama, 35209, United States

Location

Genesis Research, LLC

San Diego, California, 92123, United States

Location

Idaho Urologic Institute - Meridian

Meridian, Idaho, 83642, United States

Location

AdvanceMed Research

Lawrenceville, New Jersey, 08648, United States

Location

Carolina Clinical Trials, LLC

Concord, North Carolina, 28025, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Seattle Urology Research Center

Burien, Washington, 98166, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Dr. John Mao
• Organization: Foresee Pharmaceuticals Co., Ltd.

john.mao@foreseepharma.com

+886 2-2655-2658

Study Officials

• John Mao, Ph.D.

  Foresee Pharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2016
• First Posted: March 18, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: December 19, 2017
• Last Updated: March 26, 2019
• Results First Posted: September 12, 2018

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)