- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02712320
Open-Label Safety Extension Study in Patients Who Have Previously Participated and Have Benefited From LMIS 50 mg
March 13, 2019 updated by: Foresee Pharmaceuticals Co., Ltd.
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
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Homewood, Alabama, United States, 35209
- Urology Centers of Alabama
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California
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San Diego, California, United States, 92123
- Genesis Research, LLC
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Idaho
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Meridian, Idaho, United States, 83642
- Idaho Urologic Institute - Meridian
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New Jersey
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Lawrenceville, New Jersey, United States, 08648
- AdvanceMed Research
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North Carolina
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Concord, North Carolina, United States, 28025
- Carolina Clinical Trials, LLC
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South Carolina
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Myrtle Beach, South Carolina, United States, 29572
- Carolina Urologic Research Center
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Washington
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Burien, Washington, United States, 98166
- Seattle Urology Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
- 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
- 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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LMIS 50 mg
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)
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Subcutaneous injection of 50 mg Leuprolide Mesylate
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: Up to 48 weeks
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Evaluate the incidence of adverse events, drug-related adverse events, and serious adverse events
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Up to 48 weeks
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Evaluate the Effect of LMIS 50 mg on Cardiovascular Function
Time Frame: Up to 48 weeks
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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.
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Up to 48 weeks
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Laboratory Assessments - Hematology
Time Frame: 48 weeks
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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.
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48 weeks
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Laboratory Assessments - Biochemistry
Time Frame: 48 weeks
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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.
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48 weeks
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Laboratory Assessments - Urinalysis
Time Frame: 48 weeks
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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.
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48 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: John Mao, Ph.D., Foresee Pharmaceuticals Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2016
Primary Completion (Actual)
May 1, 2017
Study Completion (Actual)
December 19, 2017
Study Registration Dates
First Submitted
February 22, 2016
First Submitted That Met QC Criteria
March 14, 2016
First Posted (Estimate)
March 18, 2016
Study Record Updates
Last Update Posted (Actual)
March 26, 2019
Last Update Submitted That Met QC Criteria
March 13, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FP01C-13-001-EX
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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