WILEX AG - RENCAREX

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Pipeline Philosophy RENCAREX® Overview About RCC Therapeutic Target Phase I & II Phase III ARISER Markets REDECTANE® MESUPRON® WX−554 WX−037 Research Projects Publications For Patients	Phase III ARISER Study Overview Study Objectives and Design Main Inclusion Criteria: RCC Patients at High Risk of Recurrence Exclusion Criteria Status Links and Further Information Overview Clear cell renal cell carcinoma (ccRCC) is the most common form of kidney cancer. 20-40% of RCC patients have no evidence of metastases at the time of first diagnosis, but have a high risk of relapse within 2 years after the surgical resection of the affected kidney. Currently, there is no approved treatment for adjuvant therapy of ccRCC after surgery. There is a highly unmet medical need for adjuvant treatment of ccRCC patients post surgery. The Phase III ARISER study with RENCAREX® in non-metastatic ccRCC is a clinical study with the objective of demonstrating safety and efficacy of a medical treatment to address this need. Study Objectives and Design ARISER (Adjuvant RENCAREX®Immunotherapy Phase III trial to Study Efficacy in non-metastatic RCC) is a double-blind, placebo-controlled Phase III study to assess the effect of adjuvant treatment with RENCAREX® on disease-free survival and overall survival in RCC patients with a high risk of recurrence following surgery (nephrectomy). The study also assesses safety and patient's quality of life. ARISER has recruited 864 patients from over 140 centres in 14 countries. Patients received a once-weekly infusion of RENCAREX® (WX-G250) or placebo for 24 weeks. Those patients receiving the active drug (RENCAREX®) receive a loading dose of 50 mg in week 1, and weekly doses of 20 mg during weeks 2-24.
	Main Inclusion Criteria: RCC Patients at High Risk of Recurrence The study has enrolled patients with: Prior nephrectomy of primary renal cell carcinoma (RCC) with documented clear cell histology ECOG score of 0 or 1 No evidence of macroscopic or microscopic residual disease Surgery no later than 12 weeks before study entry (randomisation). In addition, patients must show one of the following “High Risk” criteria: Tumour stages > T3aN0/NXM0 Any tumour stage with N+ and M0 Tumour stage T1b/T2N0/NXM0 and grading G ³ 3 (Fuhrman or any other nuclear grading system with at least 3 grades) Main Exclusion Criteria Patients are excluded from this study with: Prior chemotherapy/immune therapy/radiotherapy within the past 5 years Pre-exposure to murine or chimeric antibody Prior organ transplantation History of prior malignancies within the past 5 years, except for surgically cured non-melanoma skin cancer or cervical carcinoma in situ Any unrelated illness, which can significantly jeopardise patients’ clinical status
	Status The positive interim analysis for futility by the Independent Data Monitoring Committee (IDMC) after 100 relapses was published in December 2007. Recruitment of the study was completed mid 2008, and the last patient finished the 24-week treatment in February 2009. The next milestone is the occurrence of the 343rd relapse. Relapses for the 864 patients in the trial continue to take longer than originally anticipated. As of the end of June 2010, a total of 324 relapses had been reported to WILEX by the local trial centres. Links and Further information More information on the study, participating countries and sites are available on the following websites: www.cancer.gov/clinicaltrials or www.clinicaltrials.gov, then search under: WX-2003-07-HR For further information you may also contact: clinical.trials@wilex.com

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