Conditions: Metastatic Renal Cell Carcinoma
Keywords: CVX-060 PF-04856884 AG-013736 axitinib mRCC metastatic renal cell cancer second line anti-angiogenic Ang-2
Allocation: RANDOMIZED | Intervention model: 
Enrollment: 18
Healthy volunteers: no

Brief summary:
To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib (AG-013736) in patients that have received one prior systemic regimen for metastatic renal cell carcinoma (mRCC) vs. axitinib alone.

Detailed description:
The study was prematurely discontinued on 06Nov2012 due to tolerability findings in patients treated in Part I of the study that have prompted the Sponsor to re-evaluate the strategic development of the program. An unexpected frequency of arterial thrombotic events (ATEs) and venous thrombotic events (VTEs) were reported in patients treated in Part I.

Arms:
arm 1: PF-04856884 in combination with AG-013736 arm 2: AG-013736 alone

Interventions: intervention 1: PF-04856884 intervention 2: Axitinib (AG-013736) intervention 3: Axitinib (AG-013736)
Intervention descriptions: intervention 1: 15 mg/kg/week intravenously \[IV\] until toxicity or disease progression intervention 2: 5 mg PO BID intervention 3: 5 mg PO BID

Protocol document: