NCT04060043

Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer

Pilot Study to Evaluate the Effects of a New Depot Formulation of Goserelin Acetate 10.8 mg, on Testosterone Levels in Ambulatory Patients With Carcinoma of the Prostate

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: CMX Research · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.

Detailed description

A 12 week (84 day) single injection study in 12 patients with carcinoma of the prostate. During the screening phase, all patients will come to the clinic for a screening visit (V1), during which the patient's eligibility will be evaluated and baseline assessments will be performed. Eligible patients will sign the informed consent form at this visit. Within 2 weeks after the screening visit, eligible patients will receive a subcutaneous injection of Pepti 10.8mg on day 0 (V2) and samples will be collected for goserelin 1h, 1.5h, 2h and 3h after the injection. Monitoring of the effects for approximate 4h after the injection will be performed. Thereafter, patients will return to the clinic for follow-up visits approximately every 2 weeks (Visit 3 to 9: Day 7, 21, 35, 49, 63, 77 and 84). The follow-up visits are planned to enable repeated blood sampling designed to evaluate the testosterone response, safety profile and PSA response.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Goserelin Acetate	The Pepti 10.8mg (goserelin acetate) implant is supplied as a cylindrical rod of biodegradable and biocompatible D, L Lactic and glycolic acids copolymer. Each implant contains goserelin acetate equivalent to 10.8mg of goserelin as well as a blend of high and low molecular weight range of D, L lactic and glycolic acids copolymer to total a weight of approximately 36.0mg per depot. The implant will be injected subcutaneously through the patient's anterior abdominal wall.

Timeline

• Start date: 2017-02-21
• Primary completion: 2017-12-06
• Completion: 2018-01-02
• First posted: 2019-08-16
• Last updated: 2021-05-10

Locations

7 sites across 2 countries: Canada, Georgia