PF-04856884 and Axitinib in Metastatic Renal Cell Carcinoma

• Research type

  Research Study

• Full title

  A PHASE II TRIAL OF PF-04856884 (CVX-060), A SELECTIVE ANGIOPOIETIN 2 (ANG-2) INHIBITOR IN COMBINATION WITH AG-013736 (AXITINIB) IN PATIENTS WITH PREVIOUSLY TREATED METASTATIC RENAL CELL CARCINOMA

• IRAS ID

  93058

• Contact name

  Martin Gore

• Sponsor organisation

  Pfizer Inc., 235 East 42nd Street, New York, NY 10017, USA

• Eudract number

  2011-002190-33

• ISRCTN Number

  xx

• Research summary

  Renal cell carcinoma (RCC) originates in very small tubes in the kidney that filter blood and remove waste products. RCC is found only in the kidney but in more advanced stages it can also metastasise (invade and spread) to other organs. RCC presents with a wide range of symptoms depending on which areas of the body have been affected, the most common being haematuria (blood in the urine) and pain. Initial treatment is most commonly total or partial surgical removal of the kidney. RCC is resistant to chemotherapy and radiotherapy in most cases, although in a small number of patients, it can respond well to medications activating natural defense mechanisms (immunotherapy). Growth and progression of RCC is thought to depend on proteins involved in the process of blood vessel formation such as Vascular Endothelial Growth Factor (VEGF) and angiopoietin -2 (Ang-2). Two new medications, PF-04856884, which inhibits Ang-2, and AG-013736, which indirectly inhibits VEGF, have shown acceptable safety and tolerability in previous clinical trials. Research supports PF-04856884 may be most effective when it??s combined with other medications similar to AG-013736, rather than alone. Pfizer is sponsoring an open label study (patients and physicians will know what treatments the patients are receiving) to assess how effective and safe PF-04856884 is in patients with previously treated metastatic renal cell carcinoma (mRCC). This study aims to find out how effective the combination of PF-04856884 and AG-013736 (axitinib) in comparison to AG-013736 alone are. Participants will be randomised (randomly allocated, like flipping a coin) to receive: - PF-04856884 and AG-013736 or - AG-013736 alone. This study is planned to take place across Europe, North and South America, and Asia and recruit 150 participants.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  12/LO/0812

• Date of REC Opinion

  24 Jul 2012

• REC opinion

  Further Information Favourable Opinion