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Molecular Screening for Cancer Treatment Optimization (MOSCATO 01)

This study is currently recruiting participants.
Verified December 2012 by Institut Gustave Roussy
Sponsor:
Information provided by (Responsible Party):
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT01566019
First received: March 27, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Metastatic Solid Tumors (Any Localization)
 Procedure: Tumoral biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Molecular Screening Analysis Used as Decision Tool for Targeted Molecular Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Progression according to RECIST criteria or clinical progression or death of any cause


Secondary Outcome Measures:
  • Number of patient who received a targeted treatment oriented by molecular profiling [ Time Frame: From the start to the end of enrollment, up to 3 years ] [ Designated as safety issue: No ]
    Number of patient who received a targeted treatment oriented by molecular profiling

  • Progression free Survival, Overall Survival and Response Rate [ Time Frame: Until progression, up to 1 year ] [ Designated as safety issue: No ]
    Comparison of Progression Free Survival, Overall Survival and Response Rate between patients with targeted treatment and others enrolled patients.


Estimated Enrollment: 1050
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Tumoral biopsy
    Every enrolled patient undergoes tumoral biopsy
  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01566019

Locations
France
Institut Gustave Roussy Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Jean-Charles SORIA, MD, PhD     +33 1 42 11 42 96     soria@igr.fr    
Contact: Christophe MASSARD, MD     +33 04 42 11 52 10     christophe.massard@igr.fr    
Principal Investigator: Jean-Charles SORIA, MD, PhD            
Sponsors and Collaborators
Institut Gustave Roussy
Investigators
Principal Investigator: Jean-Charles SORIA, MD, PhD Institut Gustave Roussy
  More Information

No publications provided

Responsible Party: Institut Gustave Roussy
ClinicalTrials.gov Identifier: NCT01566019     History of Changes
Other Study ID Numbers: 2011-A00841-40, 2011/1755
Study First Received: March 27, 2012
Last Updated: December 19, 2012
Health Authority: France: L’Agence nationale de sécurité du médicament et des produits de santé

ClinicalTrials.gov processed this record on May 16, 2013