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Pilot Study of the Treatment of Vascular Endothelial Growth Factor(VEGF)Signaling Pathway Inhibitor-Induced Hypertension

Information source: University of Chicago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Treatment Induced Hypertension

Intervention: Minoxidil (Drug); Hydralazine (Drug)

Phase: N/A

Status: Terminated

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Michael Maitland, M.D., Ph.D., Principal Investigator, Affiliation: University of Chicago


The purpose of this study is to describe the length of time and extent of blood pressure response to minoxidil and hydralazine among cancer patients with difficult-to-treat vascular endothelial growth factor (VEGF) inhibitor treatment induced hypertension.

Clinical Details

Official title: A Pilot Study of the Treatment of VEGF-Signaling Pathway Inhibitor-Induced Hypertension With Direct Vasodilators, Minoxidil and Hydralazine

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Magnitude of Change in Blood Pressure


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Ongoing treatment for malignancy by at the University of Chicago with any agent with

recognized, specific inhibition of VEGF, VEGF-receptors, or downstream signaling molecules with the specific intention of inhibiting signaling of this pathway. These agents include but are not limited to: bevacizumab (Avastin™), sorafenib (Nexavar™), sunitinib (Sutent™), axitinib (AG-013736), and AZD 2171.

- Treatment of hypertension with at least 2 or more anti-hypertensive medications with

blood pressure remaining greater than 140/90 mmHg.

- Stable management of other toxicities from the cancer treatments

- Expected to continue current cancer treatments for at least 4 weeks

- 18 years and older

- Ability to understand and the willingness to sign a written informed consent document

prior to any study specific procedures. Exclusion Criteria:

- Concurrent use of hematopoietic supportive treatment with erythropoietin or


- Current uncontrolled toxicities due to the cancer treatments.

- Patients having known contraindications to hydralazine or minoxidil therapy.

- Any readings of systolic blood pressure >200 mmHg or diastolic blood pressure >120

mmHg in the four (4) weeks prior to screening.

- Use of either minoxidil or hydralazine in the six (6) months prior to screening.

Locations and Contacts

University of Chicago, Chicago, Illinois 60637, United States
Additional Information

Starting date: January 2008
Last updated: June 3, 2014

Page last updated: August 23, 2015

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