Epidemiological Study to Identify Prognosis and Predictive Biomarkers for Advanced or Metastatic Renal Cell Carcinoma

Overview

Multicentric and prospective epidemiological study (NON INTERVETIONAL) to identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in metstatic renal cell carcinoma.

Molecular determinations will be developed ay CIMA and CNIO.

Full Title of Study: “Muticentric and Prospective Epidemiological Study to Identify Prognosis and Predictive Biomarkers of Response to Angiogenic Drugs Approved in First Line of Treatment for Advanced or Metastatic Renal Cell Carcinoma”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2016

Detailed Description

In coming years new TKIs for the treatment of mRCC are expected to be available. Identificaction of novel biomarkers is required to select those patients who would most benefit from a particular therapeutic strategy:

C-Met is a tyrosine kinase receptor involved in cellular growth and vascular develoment, also identify as a proto-oncogene.

Chemiokines: an increase in pro-angiogenic chemokines such as IL-6 & IL-8 has been also suggested as a tumor dependent possible mechanism influencing invasion and metastasis after anti-VEGF therapy.

PBRM1 (BAF 180) mutation: Second major involved gene in clear cell RCC with truncating mutations in 41% (92/227) of cases. Mutations appear to inactive a protein that plays role in remodeling the structure of genetic material.PBRM1 mutations could be (partially) involved in about 40% of clear cell RCC. PBRM1 may affect the processes of cell divsion in renal cells and could consequently be another target for new drugs.

Interventions

  • Drug: Sunitinib
    • Identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in avanced or metastatic renal cell carcinoma.

Arms, Groups and Cohorts

  • Metastatic clear cell renal carcinoma (mRCC) patients
    • Metastatic clear cell renal carcinoma (mRCC) patients cadidates to receive Sunitinib 50 mg/day 4/2 schedule or Pazopanib 800mg/day until unaccetable toxicity or progression or death under standar clinical practice.

Clinical Trial Outcome Measures

Primary Measures

  • Tissue and blood biomarkers
    • Time Frame: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study.
    • Correlate tissue and blood biomarkers with sunitinib and pazopanib efficacy in terms of progression free survival (PFS) according RECIST criteria. Tissue biomarkers: FFEP tumor tissue from filed tissue sample (pre-treatment) Serum biomarkers: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study. Peripheral blood: 0 day (pre-treatment).
  • Tissue and blood biomarkers
    • Time Frame: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study.
    • Correlate tissue and blood biomarkers with sunitinib and pazopanib efficacy in terms of overal response rate (ORR) according RECIST criteria. Tissue biomarkers: FFEP tumor tissue from filed tissue sample (pre-treatment) Serum biomarkers: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study. Peripheral blood: 0 day (pre-treatment).
  • Tissue and blood biomarkers
    • Time Frame: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study.
    • Correlate tissue and blood biomarkers with sunitinib and pazopanib efficacy in terms of overall survival (OS) according RECIST criteria. Tissue biomarkers: FFEP tumor tissue from filed tissue sample (pre-treatment) Serum biomarkers: 0 day (pre-treatment), 3month after start of treatment and after progression disease or death or end of study. Peripheral blood: 0 day (pre-treatment).
  • Tumor measure
    • Time Frame: Under Standar Clinical Practice (every 3 months)
    • Tumor measure according RECIST criteria

Participating in This Clinical Trial

Inclusion Criteria

  • Locally avanced or metastatic renal cell carcinoma with clear-cell component histology candidates to recieve sunitinib or pazopanib in fisrt line under standard clinical practice.
  • Measurable disease by CT or MRI
  • Life expectancy >3 months
  • Written informed consent.
  • Performance Status 0-2

Exclusion Criteria

  • Any patients who does not fulfill the inclusion criteria.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Spanish Oncology Genito-Urinary Group
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Emilio Esteban, MD. Phd., Principal Investigator, Hospital Universitario Central de Asturias, Spain.

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