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An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy


N/A
18 Years
N/A
Not Enrolling
Both
Carcinoma, Renal Cell

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Trial Information

An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy


It is recognized that the measurable disease RECIST criteria response rate with mTOR
inhibition is likely to be low and that the benefit of such therapy will also include
effects on disease stabilization. Disease stabilization is difficult to interpret in the
phase II setting. Thus, it is desirable to develop biomarkers which will provide additional
information on novel treatment effects and how they might relate to disease progression


Inclusion Criteria:



- All patients enrolled from Canadian centres for the Wyeth Pharmaceuticals sponsored
multicenter, open-label phase III study evaluating second line therapy with either
temsirolimus or sorafenib in patients progressing after sunitinib therapy, are
eligible for this correlative studies protocol.

- Patients must provide written informed consent.

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made

Principal Investigator

Christian Kollmannsberger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

BC Cancer Agency- Vancouver

Authority:

Canada: Health Canada

Study ID:

KNC-001

NCT ID:

NCT00538772

Start Date:

July 2008

Completion Date:

Related Keywords:

  • Carcinoma, Renal Cell
  • Metastatic Renal Cell Carcinoma
  • Biomarkers
  • Biomarkers in patients with Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
  • Carcinoma
  • Carcinoma, Renal Cell

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