Date: 2016-01-13
Type of information: Clinical research agreement
Compound: triptorelin pamoate 3.75 mg 1-month formulation
Company: Debiopharm (Switzerland) European Organisation for Research and Treatment of Cancer (EORTC)
Therapeutic area: Cancer - Oncology - Rare diseases
Type agreement: clinical research collaboration
Action mechanism: peptide. Triptorelin is a synthetic decapeptide agonist analogue that was first registered in France in 1986 and is currently marketed in more than 80 countries in various indications including advanced prostate cancer and CPP. 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/oestrogen levels (e.g. vaginal bleeding in girls) followed by almost complete suppression of testosterone/oestrogen (e.g. hot flushes and headaches).
Disease: salivary gland cancer
Details: * On January 13, 2016, Debiopharm International announced a collaboration in order to supply triptorelin pamoate 3.75 mg 1-month formulation for patients suffering from salivary gland cancer participating in a clinical study sponsored by the European Organisation for Research and Treatment of Cancer (EORTC). The EORTC intergroup trial 1206:“A randomised phase II study to evaluate the efficacy and safety of chemotherapy vs androgen deprivation therapy (ADT) in patients with recurrent and/or metastatic, androgen receptor expressing, salivary gland cancer” is coordinated by the EORTC Head and Neck Cancer Group in collaboration with the International Rare Cancer Initiative UK Salivary Gland Cancer Group. This study will accrue 152 patients at approximately 30 sites in 10 countries: Austria, Belgium, France, Germany, Greece, Hungary, Italy, the Netherlands, Portugal and the United Kingdom. The clinical study is expected to last until mid-2021. Salivary gland cancers are a rare and heterogeneous group of tumors. There is currently no standard of care for treating these cancers. The purpose of this study is to evaluate the efficacy and safety of chemotherapy versusandrogen deprivation therapy (ADT) in patients with recurrent and/or metastatic androgen receptors-expressing salivary gland cancers. In addition to the support provided by Debiopharm, this phase II study is supported by a grant from Fonds Baillet Latour covering part of the EORTC operational cost and by Cancer Research UK for drug supply, as well as by AIRC (Associazione Italiana Ricerca Cancro) entirely covering the expenses of the translational research associated with the clinical protocol.
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