Molecular Screening for Cancer Treatment Optimization

Study Overview
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Brief Summary
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The primary objective of the study is to use high throughput molecular analysis (CGH Array and sequencing) to treat patients with metastatic cancer with targeted therapeutics in order to improve the progression free survival compared to the previous treatment line. The secondary objectives are to investigate clinical practical feasibility of such technics, to potentially improve the overall survival of patients and to describe molecular portrait of Phase 1 candidates.

Official Title
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Molecular Screening Analysis Used as Decision Tool for Targeted Molecular Treatment

Conditions
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Metastatic Solid Tumors (Any Localization)

Intervention / Treatment
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* Procedure: Tumoral biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Solid tumors ; Stade IV ; Local relapse or metastatic ; Uncurable Age > 6 months PS 0/1 or Lansky play scale >= 70% Minimum one treatment line, no limit in the prior number of treatment line Evaluable or measurable disease Exclusion Criteria: Life expectancy < 3 months Carcinomatous meningitis Symptomatic or progressive radiologic brain metastasis for non-CNS tumors Polynuclear neutrophil < 1 x 10^9/L Platelets < 100 x 10^9/L Hemoglobin < 90 g/L ALT/AST > 2.5 N bilirubin > 1.5 N Creatinine >1.5 N Calcemia > ULN Phosphate > ULN Coagulation anomaly non-indicated for biopsy

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with non curable metastatic cancer<br> | Procedure: Tumoral biopsy<br>* Every enrolled patient undergoes tumoral biopsy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) using a targeted treatment selected by molecular profiling compared to the PFS for the most recent regimen | Progression according to RECIST criteria or clinical progression or death of any cause | From date of start of targeted treatment oriented by MOSCATO until the date of first progression or date of death from any cause, whichever came first, assessed up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patient who received a targeted treatment oriented by molecular profiling | Number of patient who received a targeted treatment oriented by molecular profiling | From the start to the end of enrollment, up to 3 years | 
| Progression free Survival, Overall Survival and Response Rate | Comparison of Progression Free Survival, Overall Survival and Response Rate between patients with targeted treatment and others enrolled patients. | Until progression, up to 1 year |