Date: 2011-04-13
Type of information:
phase: 2
Announcement: inclusion of the first patient
Company: PharmaMar (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: breast cancer
Therapeutic area: Cancer - Oncology
Country: Belgium, France and Spain
Trial
details: The trial will initially include 40 patients and could reach 100 depending on the activity observed in each group. The evaluation will be based on the percentage of patients whose illness has not progressed in the first four months after beginning treatment.
Five hospitals in Belgium, France and Spain will participate in the trial.
Latest
news: PharmaMar, a biopharmaceutical company in Grupo Zeltia (ZEL.MC), has included its first patient in the Phase II trial evaluating Yondelis® in patients with advanced breast cancer who have previously received at least two lines of treatment.
The patients will be divided into two groups according to levels of the protein XPG, which is present in the tumours and is linked to the mechanism of action of Yondelis®. In a previous trial, also in breast cancer, patients with high levels of XPG responded more favourably to treatment with Yondelis®.
