Molecular Screening Analysis Used as Decision Tool for Targeted Molecular Treatment
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 2,150
- Locations
- 1
- Primary Endpoint
- Progression free survival (PFS) using a targeted treatment selected by molecular profiling compared to the PFS for the most recent regimen
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients with non curable metastatic cancer
Intervention: Tumoral biopsy (Procedure)
Outcomes
Primary Outcomes
Progression free survival (PFS) using a targeted treatment selected by molecular profiling compared to the PFS for the most recent regimen
Time Frame: 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
Progression according to RECIST criteria or clinical progression or death of any cause
Secondary Outcomes
- 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(Until progression, up to 1 year)