HYPAZ: Hypertension Induced by Pazopanib (HYPAZ)
Renal Cell Carcinoma
Soft Tissue Sarcoma
Non-small Cell Lung Cancer
Small Cell Lung Cancer
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||HYPAZ: An Open-label Investigation Into Hypertension Induced by Pazopanib Therapy|
- Change in endothelial dependent function [ Time Frame: Measured over 12 weeks, or at the onset of hypertension whichever occurs first ] [ Designated as safety issue: Yes ]
- Change in endothelial independent function [ Time Frame: Measured over 12 weeks, or at onset of hypertension, whichever occurs first ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2011|
|Study Completion Date:||September 2015|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
Patients will receive 800mg (2 X 400mg tablets) of pazopanib, to be administered once daily orally for 12 weeks or until development of hypertension (defined as VHyp), whichever occurs first.
2 x 400mg pazopanib tablets taken once daily for 12 weeks
Other Name: Votrient
For this study, up to 52 patients with different cancer types will take pazopanib tablets for 12 weeks. They will visit the clinic every 1-2 weeks during treatment, and for a final safety check 4 weeks after stopping the drug (10 visits over 18 weeks).
At every visit, we will do a heart tracing, and check the patient's blood pressure and blood and urine chemicals (to check their health, and see if levels of these chemicals change). Patients will check their blood pressure at home every other day. They will also wear a blood pressure monitor for 24 hours on 3 occasions (during normal daily activities).
Patients will have 1 or 2 CT scans and 3 MRI scans during the study. On three occasions, a variety of specialised tests will measure how the patient's blood vessels are working.
Patients may choose to continue taking the drug after the 12 weeks of treatment, if their doctor feels it is appropriate.
Understanding how pazopanib causes high blood pressure will help us to advise doctors how to treat the high blood pressure effectively, so that patients can continue to take their cancer treatment safely. This research might also lead to the development of new cancer drugs in future, which do not cause this serious side effect.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01392352
|Cambridge University Hospitals NHS Foundation Trust|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|
|Principal Investigator:||Duncan I Jodrell||University of Cambridge; honorary contract with Cambridge University Hospitals NHS Foundation Trust|