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

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02712320
• Other study ID #: FP01C-13-001-EX
• Status: Completed
• Phase: Phase 3
• Start date: February 2016
• Est. completion date: December 19, 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

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.

Description:

This is a multi-center, open-label, single-arm safety extension study. After completing 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 (with last dose under Protocol FP01C-13-001 approximately 6 months prior to Day 0 or Protocol FP01C-13-001-EX) and providing a written informed consent, subjects will be screened against baseline inclusion/exclusion criteria necessary for study eligibility. Eligible subjects will receive LMIS 50 mg from the prefilled syringes (without dilution or other mixing) in up to two single subcutaneous injections given 6 months apart.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 19, 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. 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

3. Agree to use male contraceptive methods during study trial

4. 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

5. All aspects of the protocol explained and written informed consent obtained *If the patient completed 12 months of treatment with LMIS 50 mg more than 28 days prior to entering the Extension study, the Eastern Cooperative Oncology Group (ECOG), Physical Examination (PE), ECG, laboratory and Prostate Specific Antigen (PSA) tests should be repeated.

If the patient has completed 12 months of treatment with LMIS 50 mg under Protocol FP01C-13-001 within the last 28 days, they will be allowed to enter the Extension study without repeating the testosterone measurements, ECG, PE, laboratory and the PSA tests

Exclusion Criteria:

1. 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.

2. 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

3. Subject has used prohibited treatments as listed in the Section 8.2 during participation in Protocol FP01C-13-001.

4. 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

5. Investigator considers that it is no longer feasible for the subject to be included in a study of LMIS 50 mg

6. Subjects with persistent, non-castrate testosterone levels judged by the investigator

7. 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:
• LMIS 50 mg
Subcutaneous injection of 50 mg Leuprolide Mesylate

Locations

Country	Name	City	State
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	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 (2)

Lead Sponsor	Collaborator
Foresee Pharmaceuticals Co., Ltd.	QPS-Qualitix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	Evaluate the incidence of adverse events, drug-related adverse events, and serious adverse events	Up to 48 weeks
Primary	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
Primary	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
Primary	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
Primary	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