NCT02712320

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Foresee Pharmaceuticals Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	LMIS 50 mg	Subcutaneous injection of 50 mg Leuprolide Mesylate

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-05-01
• Completion: 2017-12-19
• First posted: 2016-03-18
• Last updated: 2019-03-26
• Results posted: 2018-09-12

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study