HYPAZ: Hypertension Induced by Pazopanib (HYPAZ)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01392352|
Recruitment Status : Terminated (Following DMC review, due to slow recruitment of evaluable patients.)
First Posted : July 12, 2011
Last Update Posted : January 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Soft Tissue Sarcoma Glioblastoma Ovarian Cancer Cervical Cancer Breast Cancer Non-small Cell Lung Cancer Small Cell Lung Cancer Pancreatic Cancer Melanoma Gastrointestinal Cancer||Drug: Pazopanib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||HYPAZ: An Open-label Investigation Into Hypertension Induced by Pazopanib Therapy|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2015|
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
- Change in endothelial dependent function [ Time Frame: Measured over 12 weeks, or at the onset of hypertension whichever occurs first ]
- Change in endothelial independent function [ Time Frame: Measured over 12 weeks, or at onset of hypertension, whichever occurs first ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|