NCT00511511

Brief Summary

The aim of the study is to find simple clinical and laboratory parameters to predict the development of hypertension and to elucidate the mechanism of hypertension during treatment with the tyrosine kinase inhibitor Sunitinib.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2007

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

August 3, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 5, 2010

Status Verified

July 1, 2009

First QC Date

August 3, 2007

Last Update Submit

January 4, 2010

Conditions

Hypertension

Keywords

hypertensionangiogenesis inhibitorstyrosine kinase inhibitorSunitinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Men and women, with either renal cell carcinoma or gastro intestinal stromal tumors (GIST) intended to be treated solely with Sunitinib (single-agent treatment) and who are considered fit enough by their treating physician to receive Sunitinib

You may qualify if:

  • Men and women, with either renal cell carcinoma or gastro intestinal stromal tumors (GIST) intended to be treated solely with Sunitinib (single-agent treatment) and who are considered fit enough by their treating physician to receive Sunitinib.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, 3015 CE, Netherlands

Location

Related Publications (16)

  • Zakarija A, Soff G. Update on angiogenesis inhibitors. Curr Opin Oncol. 2005 Nov;17(6):578-83. doi: 10.1097/01.cco.0000183672.15133.ab.

    PMID: 16224236BACKGROUND

  • Hurwitz H, Fehrenbacher L, Novotny W, Cartwright T, Hainsworth J, Heim W, Berlin J, Baron A, Griffing S, Holmgren E, Ferrara N, Fyfe G, Rogers B, Ross R, Kabbinavar F. Bevacizumab plus irinotecan, fluorouracil, and leucovorin for metastatic colorectal cancer. N Engl J Med. 2004 Jun 3;350(23):2335-42. doi: 10.1056/NEJMoa032691.

    PMID: 15175435BACKGROUND

  • Miller KD, Chap LI, Holmes FA, Cobleigh MA, Marcom PK, Fehrenbacher L, Dickler M, Overmoyer BA, Reimann JD, Sing AP, Langmuir V, Rugo HS. Randomized phase III trial of capecitabine compared with bevacizumab plus capecitabine in patients with previously treated metastatic breast cancer. J Clin Oncol. 2005 Feb 1;23(4):792-9. doi: 10.1200/JCO.2005.05.098.

    PMID: 15681523BACKGROUND

  • Sica DA. Angiogenesis inhibitors and hypertension: an emerging issue. J Clin Oncol. 2006 Mar 20;24(9):1329-31. doi: 10.1200/JCO.2005.04.5740. Epub 2006 Jan 30. No abstract available.

    PMID: 16446321BACKGROUND

  • Veronese ML, Mosenkis A, Flaherty KT, Gallagher M, Stevenson JP, Townsend RR, O'Dwyer PJ. Mechanisms of hypertension associated with BAY 43-9006. J Clin Oncol. 2006 Mar 20;24(9):1363-9. doi: 10.1200/JCO.2005.02.0503. Epub 2006 Jan 30.

    PMID: 16446323BACKGROUND

  • Deanfield JE, Halcox JP, Rabelink TJ. Endothelial function and dysfunction: testing and clinical relevance. Circulation. 2007 Mar 13;115(10):1285-95. doi: 10.1161/CIRCULATIONAHA.106.652859. No abstract available.

    PMID: 17353456BACKGROUND

  • Kuenen BC, Levi M, Meijers JC, Kakkar AK, van Hinsbergh VW, Kostense PJ, Pinedo HM, Hoekman K. Analysis of coagulation cascade and endothelial cell activation during inhibition of vascular endothelial growth factor/vascular endothelial growth factor receptor pathway in cancer patients. Arterioscler Thromb Vasc Biol. 2002 Sep 1;22(9):1500-5. doi: 10.1161/01.atv.0000030186.66672.36.

    PMID: 12231573BACKGROUND

  • Bosnjak JJ, Terata K, Miura H, Sato A, Nicolosi AC, McDonald M, Manthei SA, Saito T, Hatoum OA, Gutterman DD. Mechanism of thrombin-induced vasodilation in human coronary arterioles. Am J Physiol Heart Circ Physiol. 2003 Apr;284(4):H1080-6. doi: 10.1152/ajpheart.00465.2002. Epub 2002 Dec 19.

    PMID: 12595282BACKGROUND

  • Touyz RM. Regulation of endothelial nitric oxide synthase by thrombin. Hypertension. 2007 Mar;49(3):429-31. doi: 10.1161/01.HYP.0000255955.75119.1a. Epub 2007 Jan 8. No abstract available.

    PMID: 17210837BACKGROUND

  • Ferrara N, Gerber HP, LeCouter J. The biology of VEGF and its receptors. Nat Med. 2003 Jun;9(6):669-76. doi: 10.1038/nm0603-669.

    PMID: 12778165BACKGROUND

  • Henry TD, Annex BH, McKendall GR, Azrin MA, Lopez JJ, Giordano FJ, Shah PK, Willerson JT, Benza RL, Berman DS, Gibson CM, Bajamonde A, Rundle AC, Fine J, McCluskey ER; VIVA Investigators. The VIVA trial: Vascular endothelial growth factor in Ischemia for Vascular Angiogenesis. Circulation. 2003 Mar 18;107(10):1359-65. doi: 10.1161/01.cir.0000061911.47710.8a.

    PMID: 12642354BACKGROUND

  • Hood JD, Meininger CJ, Ziche M, Granger HJ. VEGF upregulates ecNOS message, protein, and NO production in human endothelial cells. Am J Physiol. 1998 Mar;274(3):H1054-8. doi: 10.1152/ajpheart.1998.274.3.H1054.

    PMID: 9530221BACKGROUND

  • Li B, Ogasawara AK, Yang R, Wei W, He GW, Zioncheck TF, Bunting S, de Vos AM, Jin H. KDR (VEGF receptor 2) is the major mediator for the hypotensive effect of VEGF. Hypertension. 2002 Jun;39(6):1095-100. doi: 10.1161/01.hyp.0000018588.56950.7a.

    PMID: 12052848BACKGROUND

  • Broere A, Van Den Meiracker AH, Boomsma F, Derkx FH, Veld AJ, Schalekamp MA. Human renal and systemic hemodynamic, natriuretic, and neurohumoral responses to different doses of L-NAME. Am J Physiol. 1998 Dec;275(6):F870-7. doi: 10.1152/ajprenal.1998.275.6.F870.

    PMID: 9843903BACKGROUND

  • van der Linde NA, Boomsma F, van den Meiracker AH. Role of nitric oxide in modulating systemic pressor responses to different vasoconstrictors in man. J Hypertens. 2005 May;23(5):1009-15. doi: 10.1097/01.hjh.0000166842.65097.b1.

    PMID: 15834287BACKGROUND

  • Kappers MH, van Esch JH, Sluiter W, Sleijfer S, Danser AH, van den Meiracker AH. Hypertension induced by the tyrosine kinase inhibitor sunitinib is associated with increased circulating endothelin-1 levels. Hypertension. 2010 Oct;56(4):675-81. doi: 10.1161/HYPERTENSIONAHA.109.149690. Epub 2010 Aug 23.

    PMID: 20733093DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and urine samples

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • A. H. van den Meiracker, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2007

First Posted

August 6, 2007

Study Start

August 1, 2007

Study Completion

December 1, 2009

Last Updated

January 5, 2010

Record last verified: 2009-07

Locations

NL(1)