First Line Pazopanib in Poor Risk Patients With Metastatic Renal Cell Carcinoma (FLIPPER)
Patients with advanced renal cell carcinoma (RCC) are classified according to Memorial Sloan-Kettering Cancer Center (MSKCC) criteria in three risk-groups: favourable, intermediate and poor. To our knowledge there is only one study which examined the poor risk group (Hudes et al.), which led to the approval of temsirolimus in this population. However temsirolimus demonstrated a low response rate of 8.6% according to Response Evaluation Criteria In Solid Tumor (RECIST) criteria and a Progression free Survival (PFS) of 5.5 months and not all patients are suitable for temsirolimus treatment.
Thus, in clinical routine high-risk patients are also treated with multi Tyrosinkinase Inhibitors (mTKI). To date, a prospective data acquisition and control of effectiveness of a mTKI-treatment in high-risk patients has not been conducted.
Pazopanib was recently approved for the first-line treatment of advanced renal cell carcinoma in Europe and the USA. In the pivotal Phase III trial only nine patients in the pazopanib group were poor risk according to MSKCC risk criteria and no analysis of this subgroup was performed. Therefore further data in this group of patients with high medical need is needed.
Currently there are no well-established predictive or prognostic biomarkers in RCC-mTKI treatment. This is one of the most important scientific questions in this field. In addition to the clinical endpoints in this study, the comprehensive biomarker program seeks to evaluate biomarker candidates and will help to learn more about the effects of pazopanib on the human organism.
|Locally Advanced and/or Metastatic Renal Cell Carcinoma Carcinoma, Renal Cell Clear-cell Metastatic Renal Cell Carcinoma||Drug: Pazopanib||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Single Arm Multicentre Study Evaluating Pazopanib in First-line Treatment of Poor-risk Patients With Locally Advanced or Metastatic Renal Cell Carcinoma|
- Rate of poor risk patients as defined by the Memorial Sloan-Kettering Cancer Center (MSKCC) criteria who are free of disease progression at 6 months after start of first line treatment with pazopanib. [ Time Frame: from registration until progression of disease or death, assessed up to 6 months ]
- Overall survival of poor risk patients treated with pazopanib. [ Time Frame: from registration until death of any cause assessed up 24 months ]
- Number, characteristics and severity of Adverse Events [ Time Frame: from first dose of pazopanib until 30 days after last dose, death or end of study, whichever came first ]
- Progression free survival of patients treated with pazopanib [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months ]
- Overall response rate and duration of response according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months ]
- Relation between biomarkers and clinical outcome (response, stable disease, progression of disease) [ Time Frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months ]
|Actual Study Start Date:||January 24, 2012|
|Estimated Study Completion Date:||July 31, 2017|
|Estimated Primary Completion Date:||June 30, 2017 (Final data collection date for primary outcome measure)|
800 mg (2x400mg) pazopanib per day
800 mg (2x400mg) pazopanib per day should be taken orally without food at least one hour before or two hours after a meal until progression or occurrence of intolerable toxicity.
Other Name: Votrient
Please refer to this study by its ClinicalTrials.gov identifier: NCT01521715
|Urolog. Klinik im Waldkrankenhaus St. Marien, Friedrich-Alexander-Universität|
|Erlangen, Germany, 91054|
|Universitätsklinikum Essen, Klinik f. Urologie|
|Essen, Germany, 45122|
|Med. Klinik II, Johann-Wolfgang-Goethe-Universität|
|Frankfurt, Germany, 60590|
|Medizinisches Versorgungszentrum (MVZ) Osthessen GmbH|
|Fulda, Germany, 36043|
|Greifswald, Germany, 17475|
|Medizinische Hochschule Hannover|
|Hannover, Germany, 30625|
|Ludwig-Maximilians-Universität (LMU) München, Klinikum Grosshadern|
|München, Germany, 81377|
|Münster, Germany, 48149|
|Principal Investigator:||Michael Staehler, PD MD||Ludwig-Maximilians-Universität München, Klinikum Grosshadern|