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Molecular Screening for Cancer Treatment Optimization (MOSCATO 02)

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ClinicalTrials.gov Identifier: NCT01566019
Recruitment Status : Recruiting
First Posted : March 29, 2012
Last Update Posted : July 12, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Metastatic Solid Tumors (Any Localization) Procedure: Tumoral biopsy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1050 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Molecular Screening Analysis Used as Decision Tool for Targeted Molecular Treatment
Study Start Date : October 2011
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019
Arms and Interventions

Arm Intervention/treatment
Experimental: Patients with non curable metastatic cancer Procedure: Tumoral biopsy
Every enrolled patient undergoes tumoral biopsy


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]
    Number of patient who received a targeted treatment oriented by molecular profiling

  2. Progression free Survival, Overall Survival and Response Rate [ Time Frame: Until progression, up to 1 year ]
    Comparison of Progression Free Survival, Overall Survival and Response Rate between patients with targeted treatment and others enrolled patients.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
  • 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
Contacts and Locations

Information from the National Library of Medicine

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): 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
Gustave Roussy, Cancer Campus, Grand Paris
Investigators
Principal Investigator: Jean-Charles SORIA, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
More Information