Date: 2013-09-25
Type of information:
phase: 2
Announcement: initiatiion of the study
Company: PharmaMar, Zeltia Group (Spain)
Product: Yondelis® (trabectedin)
Action mechanism: Yondelis® (trabectedin) is an antitumour agent of marine origin discovered in the colonial tunicate Ecteinascidia turbinata. It is currently produced by chemical synthesis. It binds to the minor groove of the DNA and interferes with cell division and the gene transcription processes and repair machinery of the DNA.
Disease: unresectable malignant pleural mesothelioma
Therapeutic area: Cancer - Oncology
Country: Italy
Trial
details: The primary objective of the trial is to assess the activity of Yondelis® in patients with epithelial MPM relapsing after treatment with pemetrexed plus platinum-based drugs.Secondary objectives:• To assess the activity of Yondelis® in untreated patients with biphasic or sarcomatoid MPM.• To assess the tolerability and safety of treatment with Yondelis®.• To assess the capability of Yondelis® to reduce pain intensity and dosage of analgesic drugs.• To explore the activity of Yondelis® with respect to some biological features of the disease; an ancillary study will be undertaken to investigate miR profiles in neoplastic tissue before treatment with Yondelis®, and in plasma before and after Yondelis® treatment. In all other cases plasma miR profiles will be assessed beforeand during Yondelis® therapy.The trial will be performed in 5 hospitals in Italy: S.GerardoHospital (Monza), HumanitasGavazzeni (Bergamo), OspedaleCivile S.S. Antonio e Biagio (Alessandria), PresidioOspedalieroSpedaliCivili (Brescia), and IstitutoClinicoHumanitasRozzano.
Latest
news: * On September 25, 2013, PharmaMar (Zeltia Group) has announced that the IRCCS-Istituto di Ricerche Farmacologiche “MARIO NEGRI”, in partnership with the Medical Oncology Department of the S. Gerardo Hospital, directed by Professor Paolo Bidoli, have commenced a phase II study to assess the activity and safety of Yondelis® in the treatment of unresectable malignant pleural mesothelioma (MPM).In Europe, Yondelis® is already indicated for the treatment of patients with advanced soft tissue sarcoma, after failure of anthracyclines and ifosfamide, or who are not suitable for treatment with these agents, and in association with pegylated liposomal doxorubicin for platinum-sensitive recurrent ovarian cancer.
