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news.Debiopharm International has announced a collaboration in order to supply triptorelin pamoate 3.75 mg 1-month formulation for patients suffering from salivary cancer participating in a clinical study sponsored by the European Organisation for Research and Treatment of Cancer (EORTC).
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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.
Lisa Licitra of the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy, and Coordinator of this study says, "Androgen, estrogen and progesterone play a key role in the growth and development of several cancer types, e.g. breast, endometrium and prostate, and since the discovery of androgen receptors in salivary gland tumors, it is thought that androgen deprivation therapy might be beneficial for patients with androgen receptor expressing, salivary gland cancer.
"The EORTC 1206 intergroup trial will evaluate the efficacy and safety of androgen deprivation therapy versus chemotherapy in patients with recurrent and/or metastatic, salivary gland cancer."
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.
Debiopharm medical director Eija Lundstrom said: "Androgen deprivation therapy with triptorelin may slow progression of salivary gland cancers expressing androgen receptors.
"We are committed to support the clinical investigation of this promising treatment option of these rare 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.
About Triptorelin
Triptorelin is an agonist analogue of the natural gonadotropin-releasing hormone (GnRH). Debiopharm has developed three sustained-release formulations (1, 3 and 6 months) of triptorelin pamoate.
The 1-, 3- and 6-month formulations have been registered in numerous countries in several indications, mainly for advanced prostate cancer and endometriosis, and are available under different brand names: Trelstar®, Decapeptyl® and Pamorelin®.