WINTHER: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening
Progression Free Survival
To assess the individual outcome of patients with advanced malignancies, by comparing the progression-free survival (PFS) using a treatment regimen selected by a molecular analysis of a patient's tumor with the PFS for the most recent regimen on which the patient had experienced progression ARM A : PFS2/PFS1 >1.5 in 50% of patients ARM B : PFS2/PFS1 >1.5 in 40% of patients The primary endpoint of the study is the ratio of the PFS of the current treatment (PFS2) versus the previous treatment (PFS1). Because patients will be enrolled in the study while they are still on treatment (before progression), we expect that PFS for the previous treatment is fully observed. If patients withdrew from the treatment due to treatment related toxicity and lost to follow-up, it is considered that the PFS endpoint is reached. If patients are lost to follow up due to other reasons, PFS is censored at the time of last follow up.
Up to 6 months
France: Agence Nationale de Sécurité du Médicament et des produits de santé