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

Tracking Information

First Received Date ^ICMJE

March 27, 2012

Last Updated Date

December 19, 2012

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

October 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Progression according to RECIST criteria or death of any cause

Change History

Complete list of historical versions of study NCT01566019 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label

Condition ^ICMJE

Metastatic Solid Tumors (Any Localization)

Intervention ^ICMJE

Procedure: Tumoral biopsy

Every enrolled patient undergoes tumoral biopsy

Study Arm (s)

Not Provided

Publications *

Not Provided

* 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

1050

Estimated Completion Date

October 2015

Estimated Primary Completion Date

October 2014 (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
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

Gender

Both

Ages

6 Months and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01566019

Other Study ID Numbers ^ICMJE

2011-A00841-40, 2011/1755

Has Data Monitoring Committee

Responsible Party

Institut Gustave Roussy

Study Sponsor ^ICMJE

Institut Gustave Roussy

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jean-Charles SORIA, MD, PhD

Institut Gustave Roussy

Information Provided By

Institut Gustave Roussy

Verification Date

December 2012

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

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