Date: 2012-07-24
Type of information: Treatment of the first patient
phase: 3
Announcement: treatment of the first patient
Company: Debiopharm (Switzerland)
Product: Debio 8206 (triptorelin pamoate 22.5 mg 6-month formulation)
Action
mechanism: Triptorelin is a synthetic decapeptide agonist analogue of GnRH that was first registered in France in 1986 and is currently marketed in more than 80 countries in various indications including advanced prostate cancer. Chronic administration of triptorelin causes down regulation of the pituitary GnRH receptors and suppresses gonadotropin (LH and FSH) secretion and finally the release of gonadal sex hormones. Triptorelin shows a safety profile similar to other GnRH agonists. Except for injection site reactions or rare immunoallergic reactions, the side effects of triptorelin are mostly due to the initial increase in testosterone (temporary worsening of the symptoms including bone pain within the first days of treatment) followed by almost complete suppression of testosterone (e.g. hot flushes and headaches).
Disease: advanced prostate cancer
Therapeutic area: Cancer - Oncology
Country: South Africa
Trial
details: This multicentre, open, non-comparative Phase III study aims to investigate the efficacy, safety, and pharmacokinetics of two subcutaneous (SC) injections of Debio 8206 in patients with advanced prostate cancer.
The study will be conducted in the Republic of South Africa and will involve 120 patients suffering mainly from advanced prostate cancer. Patients with recurrent lower stage prostate cancer and rising prostate specific antigen (PSA) following local therapy failure who are candidates for androgen deprivation therapy will also take part. Patient evaluation will be primarily based on the efficacy in achieving castrate levels of testosterone (< 1.735 nmol/L [50 ng/dL]) 28 days after the first injection of Debio 8206 and in maintaining castrate levels of testosterone from Day 57 to Day 337. The safety profile will also be evaluated. Additional efficacy measures will include the assessment of the percentage of patients who show an increase in testosterone levels 48 hours after the second injection of Debio 8206, as well as the absence of gonadotropin (LH) stimulation 2 hours after the second injection of Debio 8206 and the change in PSA from baseline to study end. In addition, Debio 8206 pharmacokinetics and testosterone pharmacodynamics will be assessed in a subset of 15 patients.
Latest
news: Debiopharm, a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs and companion diagnostics, has announced the treatment of its first patient in a multicentre, open, non-comparative Phase III study to investigate the efficacy, safety, and pharmacokinetics of two subcutaneous (SC) injections of Debio 8206 (triptorelin pamoate 22.5 mg 6-month formulation) in patients with advanced prostate cancer.
The study will be conducted in the Republic of South Africa and will involve 120 patients suffering mainly from advanced prostate cancer. Patients with recurrent lower stage prostate cancer and rising prostate specific antigen (PSA) following local therapy failure who are candidates for androgen deprivation therapy will also take part.
The 6-month formulation is currently commercialised for an administration by the intramuscular (IM) route in several countries.
