Date: 2012-06-14
Type of information: Results
phase: 2
Announcement: results
Company: Wilex (Germany)
Product: Mesupron® (upamostat)
Action mechanism:
Disease: HER2-receptor negative metastatic breast cancer
Therapeutic area: Cancer - Oncology
Country: Belgium, Brazil, Germany, Israel, USA
Trial
details: The uPA inhibitor Mesupron® is given in combination with the chemotherapeutic agent capecitabine (Xeloda®, Roche). The double blind two arm randomised Phase II trial will evaluate the efficacy and safety of the combination therapy in comparison to capecitabine monotherapy. In the study 132 patients in 20 centres in five countries (Belgium, Brazil, Germany, Israel, US) were enrolled. Progression free survival is defined as the primary endpoint of the trial. The study will also evaluate the objective response rate, the overall survival and safety as well as pharmacokinetics.
Latest
news: * On June 14, 2012, Wilex has published data from its Phase II trial with its oral drug candidate Mesupron® in first line treatment of patients with HER2-receptor negative metastatic breast cancer. Mesupron® was given in combination with capecitabine (Xeloda®). The primary objective of the study was to evaluate the efficacy of the combination of Mesupron® and capecitabine compared to capecitabine alone by assessment of progression free survival (PFS). The study also evaluated the objective response rate, overall survival and safety as well as pharmacokinetics. Efficacy was evaluated by RECIST (Response Evaluation Criteria on Solid Tumours) by independent central read using computed tomography and bone scans.In the total study population (intent to treat; ITT) Mesupron® led to an increase of median progression free survival from 7.5 months in the control group to 8.3 months in the combination therapy. Capecitabine alone demonstrated an objective tumour response rate of 9%. Co-administration of 200 mg Mesupron® almost doubled the response rate to 17%. Overall survival data have not matured yet as over 60% of patients were still alive at the time of analysis. The combination therapy of Mesupron® and capecitabine was safe and welltolerated. Pharmacokinetic analysis demonstrated no drug-drug interactions between Mesupron® and capecitabine.To test whether Mesupron® also shows efficacy in a more homogeneous patient population two subgroups were evaluated which had sufficient numbers of patients to allow separate analysis:In the subgroup of patients who were Caucasian (n=109) median PFS improved from 7.5 months in the control group to 9.1 months in patients treated with Mesupron®.In the subgroup of patients (n=95) who received adjuvant chemotherapy following the primary diagnosis of breast cancer, PFS improved from 4.3 months in the capecitabine alone group to 8.3 months in the Mesupron®combination group.* On May 5, 2011, Wilex has announced that it has successfully completed patient recruitment in the clinical Phase II trial with its oral drug candidate Mesupron® in first line treatment of patients with HER2-receptor negative metastatic breast cancer. This trial is supported by the US Department of Defense in their Breast Cancer Research Program.
