Clinical Benefit of Genetic Biomarkers for Guiding Treatment Decisions in Oncology Drugs

Neoplasms Clinical Trial

Official title:

Clinical Benefit of Genetic Biomarkers for Guiding Treatment Decisions in Oncology Drugs

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02458040
• Other study ID #: BENEBIO01
• Secondary ID: PHRCK14-051
• Status: Withdrawn
• Start date: May 2015
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a meta-epidemiological study which aim is to quantify the clinical benefit of the biomarker-based strategy compared to conventional strategy across all drugs with such a strategy.

Description:

Personalized medicine consist to differentially treat patients based on their individual characteristics (mainly genetics). It is of the most promising area of cancer research and cancer care. The label of more than 140 FDA- approved drugs mention a biomarker, the majority being indicated in oncology. However, it has also been suggested that the hopes of personalized medicine were not matched by evidence. Indeed, there is a threat that genetic biomarkers are used without evidence that this use translates in improved outcomes for patients, and the use of biomarkers is in need for thorough validation.

In a previous work the investigators showed that the mention of a pharmacogenomic biomarker in a drug label can have different meanings depending on the drug, and that oncology had higher proportion of required or recommended genetic testing compared to other therapeutic areas. Hence, the investigators will include only the drug-biomarker pairs with (i) required or recommended genetic testing, or (ii) with biomarker-based indication and (iii) with at least one indication in oncology.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• phase II or III randomized clinical trials

• including patients with one of the drug-biomarker-indication triplet studied

• evaluating treatment effect in biomarker-defined strata (either in biomarker-positive patients, in biomarker-negative patients or in both strata).

• reporting OS or PFS or DFS

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Neoplasms

Intervention

Drug:
• Drug selected in the study

Locations

Country	Name	City	State
France	Hôpital Hôtel Dieu	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (2)

Vivot A, Boutron I, Beraud-Chaulet G, Zeitoun JD, Ravaud P, Porcher R. Evidence for Treatment-by-Biomarker interaction for FDA-approved Oncology Drugs with Required Pharmacogenomic Biomarker Testing. Sci Rep. 2017 Jul 31;7(1):6882. doi: 10.1038/s41598-017 — View Citation

Vivot A, Boutron I, Ravaud P, Porcher R. Guidance for pharmacogenomic biomarker testing in labels of FDA-approved drugs. Genet Med. 2015 Sep;17(9):733-8. doi: 10.1038/gim.2014.181. Epub 2014 Dec 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Disease-Free Survival (DFS)		Up to 5 years
Primary	Overall Survival (OS)		Up to 5 years
Secondary	Progression-Free Survival (PFS)		Up to 5 years