Phase III, open-label, multi-center study to assess the pharmacodynamic (PD), pharmacokinetic (PK) and safety of Zoreline 10.8 mg goserelin subcutaneous implant (Novalon) in male patients with prostate cancer - 0080CA002

ovalon S. A.0 sites142 target enrollmentNovember 14, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: ovalon S. A.
Enrollment: 142
Status: Active, not recruiting
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 14, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Male

Investigators

Sponsor

ovalon S. A.

Eligibility Criteria

Inclusion Criteria

•1\. Males aged 18 years (inclusive) or above
•2\. Histologically confirmed prostate adenocarcinoma and indicated for androgen deprivation therapy (ADT). Previous prostatectomy and/or prostate radiotherapy is allowed.
•3\. Good physical and mental health as judged by the Investigator determined by medical history, physical examination, clinical laboratory and vital signs
•4\. Willing to give informed consent in writing
•5\. Willing and able to attend the scheduled study visits and to comply with the study procedures
•6\. Baseline testosterone level \> 250 ng/dL
•7\. PSA level \= 4 ng/mL
•Exception: for patients who have had previous prostatectomy and/or prostate radiotherapy, all PSA levels are allowed.
•8\. Life expectancy \> 1 year
•9\. Body Mass Index between 18\.5 and 35 kg/m2 inclusive

Exclusion Criteria

•1\. Previous or current hormonal management of prostate cancer (surgical castration or other hormonal manipulation, including GnRH receptor agonists, GnRH receptor antagonists, anti\-androgens, estrogens) within 6 months prior to the Screening visit
•2\. Scheduled for prostatectomy or radiotherapy during study period
•3\. ALT (SGOT) or AST (SGPT) \=2x upper limit of normal (ULN)
•4\. moderate (stage 3B) or severe (stage 4 and 5\) chronic kidney disease with an eGFR \<45 mL/min/1,73m2
•5\. Has received an investigational drug within the last 28 days before the screening visit or longer if considered by the Investigator to possibly influencing the outcome of this trial
•6\. History or presence of any malignancy other than treated squamous cell/basal cell carcinoma of the skin within the last five years
•7\. Have an unstable medical condition or chronic disease (including history of neurological \[including cognitive], hepatic, renal, cardiovascular, gastrointestinal, pulmonary, or endocrine disease), or malignancy that could confound interpretation of the study at Investigator discretion
•8\. History of severe uncontrolled asthma, anaphylactic reactions, or severe urticarial and/or angioedema, and particularly, history of hypersensitivity towards any components of the study drug
•9\. Other abnormal laboratory results which in the judgment of the Investigator would affect the patient's health or the outcome of the trial
•10\. Has an intellectual incapacity or language barrier precluding adequate understanding or co\-operation