Molecular Screening for Cancer Treatment Optimization (MOSCATO 02)

• ClinicalTrials.gov Identifier: NCT01566019
• Recruitment Status: Unknown
• First Posted: March 29, 2012
• Last Update Posted: February 17, 2020
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Information provided by (Responsible Party): Gustave Roussy, Cancer Campus, Grand Paris

Tracking Information

• First Submitted Date: March 27, 2012
• First Posted Date: March 29, 2012
• Last Update Posted Date: February 17, 2020
• Actual Study Start Date: October 28, 2011
• Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

Current Secondary Outcome Measures (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 (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: Molecular Screening for Cancer Treatment Optimization
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Metastatic Solid Tumors (Any Localization)

Intervention

Procedure: Tumoral biopsy

Every enrolled patient undergoes tumoral biopsy

Study Arms

Experimental: Patients with non curable metastatic cancer

Intervention: Procedure: Tumoral biopsy

Publications *

• Martin-Romano P, Colmet-Daage L, Morel D, Baldini C, Verlingue L, Bahleda R, Gazzah A, Champiat S, Varga A, Michot JM, Ngo-Camus M, Nicotra C, Marabelle A, Soria JC, Rouleau E, Lacroix L, Hollebecque A, Massard C, Postel-Vinay S. Epigenetic gene alterations in metastatic solid tumours: results from the prospective precision medicine MOSCATO and MATCH-R trials. Eur J Cancer. 2022 Sep;173:133-145. doi: 10.1016/j.ejca.2022.06.014. Epub 2022 Jul 21.
• Verlingue L, Hollebecque A, Lacroix L, Postel-Vinay S, Varga A, El Dakdouki Y, Baldini C, Balheda R, Gazzah A, Michot JM, Marabelle A, Mir O, Arnedos M, Rouleau E, Solary E, De Baere T, Angevin E, Armand JP, Michiels S, Andre F, Deutsch E, Scoazec JY, Soria JC, Massard C. Human epidermal receptor family inhibitors in patients with ERBB3 mutated cancers: Entering the back door. Eur J Cancer. 2018 Mar;92:1-10. doi: 10.1016/j.ejca.2017.12.020. Epub 2018 Feb 3.
• Verlingue L, Malka D, Allorant A, Massard C, Ferte C, Lacroix L, Rouleau E, Auger N, Ngo M, Nicotra C, De Baere T, Tselikas L, Ba B, Michiels S, Scoazec JY, Boige V, Ducreux M, Soria JC, Hollebecque A. Precision medicine for patients with advanced biliary tract cancers: An effective strategy within the prospective MOSCATO-01 trial. Eur J Cancer. 2017 Dec;87:122-130. doi: 10.1016/j.ejca.2017.10.013. Epub 2017 Nov 14. Erratum In: Eur J Cancer. 2018 Feb 14;:
• Jovelet C, Ileana E, Le Deley MC, Motte N, Rosellini S, Romero A, Lefebvre C, Pedrero M, Pata-Merci N, Droin N, Deloger M, Massard C, Hollebecque A, Ferte C, Boichard A, Postel-Vinay S, Ngo-Camus M, De Baere T, Vielh P, Scoazec JY, Vassal G, Eggermont A, Andre F, Soria JC, Lacroix L. Circulating Cell-Free Tumor DNA Analysis of 50 Genes by Next-Generation Sequencing in the Prospective MOSCATO Trial. Clin Cancer Res. 2016 Jun 15;22(12):2960-8. doi: 10.1158/1078-0432.CCR-15-2470. Epub 2016 Jan 12.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 14, 2020): 2150
• Original Estimated Enrollment (submitted: March 28, 2012): 900
• Estimated Study Completion Date: October 2020
• Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 6 Months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT01566019
• Other Study ID Numbers: 2011-A00841-40; 2011/1755 ( Other Identifier: CSET number )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
• Original Responsible Party: Same as current
• Current Study Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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