A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies (WINTHER)
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|ClinicalTrials.gov Identifier: NCT01856296|
Recruitment Status : Suspended
First Posted : May 17, 2013
Last Update Posted : August 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer||Procedure: Biopsy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||WINTHER: A Study to Select Rational Therapeutics Based on the Analysis of Matched Tumor and Normal Biopsies in Subjects With Advanced Malignancies|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
Experimental: Arm A
ARM A patients with an identified oncogenic driver mutations/amplifications/translocations), who will potentially benefit from targeted therapies, either on the market or in clinical trials according to existing knowledge of matching oncogenic events with actionable drugs. This will be detected through Next Generation Sequencing (NGS) performed by Foundation Medicine, CLIA certified.
Experimental: Arm B
patients negative for oncogene events (which remains the majority), for whom genome based relevant information will be obtained through functional genomics (micro arrays and gene expression profiling) performed by Institut Gustave Roussy, and innovative computational methods enabling a rational choice of therapies. For such patients we will apply a new prediction model of efficacy of existing and under clinical trial drugs, based on differences in gene expression profiling between tumor and normal biopsies to be matched with relevant genes that are related to drug activities.
- Progression Free Survival [ Time Frame: Up to 6 months ]
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01856296
|Institut Gustave Roussy|
|Villejuif, Val de Marne, France, 94805|