Metastatic Cancer
Conditions
Brief summary
An open non-randomized study using biology driven selection of therapies. WINTHER study will explore matched tumoral and normal tissue biopsies and will use a novel method for predicting efficacy of drugs. The aim is to provide a rational personalized therapeutic choice to all (100 %) patients enrolled in the study, harboring oncogenic events (mutations/ translocations/ amplifications, etc.) or not. The total number of patients treated in the study will be two hundred across all participating cancer centers (European countries -France; Spain-, Israel, USA and Canada). All centers will realize the same study independently.
Interventions
PROCEDUREBiopsy
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent * Any histologic type of metastatic cancer, (except for lung and brain at US sites), in which histologic normal counterpart can be obtained. * Progression by RECIST (Response Evaluation Criteria In Solid Tumors) or other criteria on at least one prior regimen for advanced disease. * Ability to undergo a biopsy or surgical procedure to obtain fresh tumor biopsy paired with its normal counterpart. * Age from 18 years * Life expectancy of at least 3 months * ECOG Performance status of 0 to 1 * Measurable or evaluable disease according to RECIST 1.1 criteria * For U.S. sites, advanced cancer patients that have exhausted all effective therapy for their disease and have progressed after previous line of therapy (documented disease progression under last treatment received) and conventional methods of assigning new therapy would not be expected to increase survival by more than 3 months.
Exclusion criteria
* Any patient that might require a lung or brain biopsy are excluded (at US sites) * Alteration of organ function or hematopoietic function as defined by the following criteria: 1. Serum aspartate transaminase (AST) and serum alanine transaminase (ALT) \>2.5 x upper limit of normal (ULN), except for patients with liver metastases, for which AST and ALT \> 5.0 ULN is the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival | 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. |
Countries
France
Outcome results
None listed