Date: 2011-06-06
Type of
information: discontinuation of development
phase: 2
Announcement: discontinuation of development
Company: Ipsen (France)
Product: Irosustat
Action
mechanism:
Disease: endometrial cancer
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
- The European clinical trial compares single-agent Irosustat to megestrol acetate (MA) in post-menopausal women with histologically confirmed hormone receptor positive endometrial cancer, presenting with recurrent or advanced disease not eligible for treatment with surgery and radiotherapy.
The primary endpoint for the study was the proportion of patients who have neither progressed nor died after 6 months of treatment with Irosustat. Progression free survival (PFS), clinical benefits and overall survival were evaluated as secondary endpoints.
Latest
news:
- Ipsen has decided to assess the alternative development of Irosustat (BN 83495) in combination with other hormonal therapies. This decision is based on the futility analysis from the proof-of-concept trial phase II clinical study carried out in Europe in monotherapy in endometrial cancer, and on the phase I/II clinical study results obtained in metastatic prostate and breast cancers.
The futility analysis of the European study in patients suffering from endometrial cancer demonstrates that the primary endpoint will not be reached (patients on treatment for more than 6 months without progression) and that the superiority will not be demonstrated with Irosustat versus megestrol acetate in terms of progression free survival (PFS). Thus, Ipsen has decided to discontinue the development of Irosustat in monotherapy. Of note, the treatment was well tolerated and has shown an inhibition of the steroid sulfatase associated with a significant reduction in the levels of some circulating steroid hormones and with in some patients, prolonged clinical partial responses, demonstrating the clinical interest of sulfatase inhibition.
On the basis of this clinical safety profile associated with the reduction of hormonal parameters and with this potentially encouraging clinical efficacy signal in monotherapy, Ipsen will explore options to develop Irosustat in combination with other hormonal therapies in hormone-dependent cancers. This perspective comes in line with the recommendation of clinical expert committees. There are three Ipsen sponsored ongoing clinical studies for which Ipsen is discontinuing patient recruitment.
Is
general: Yes
