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Molecular Screening for Cancer Treatment Optimization (MOSCATO 02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01566019
Recruitment Status : Recruiting
First Posted : March 29, 2012
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information
First Submitted Date  ICMJE March 27, 2012
First Posted Date  ICMJE March 29, 2012
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE October 28, 2011
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2012)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
Progression free survival 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 death of any cause
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2012)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 28, 2012)
  • 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
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Molecular Screening for Cancer Treatment Optimization
Official Title  ICMJE Molecular Screening Analysis Used as Decision Tool for Targeted Molecular Treatment
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Metastatic Solid Tumors (Any Localization)
Intervention  ICMJE Procedure: Tumoral biopsy
Every enrolled patient undergoes tumoral biopsy
Study Arms  ICMJE Experimental: Patients with non curable metastatic cancer
Intervention: Procedure: Tumoral biopsy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2020)
2150
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2012)
900
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01566019
Other Study ID Numbers  ICMJE 2011-A00841-40
2011/1755 ( Other Identifier: CSET number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gustave Roussy, Cancer Campus, Grand Paris
Study Sponsor  ICMJE Gustave Roussy, Cancer Campus, Grand Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Charles SORIA, MD, PhD Gustave Roussy, Cancer Campus, Grand Paris
PRS Account Gustave Roussy, Cancer Campus, Grand Paris
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP