Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00452218
Status:
COMPLETED
Last Update Posted:
2016-08-24
First Post:
2007-03-26
Brief Title:
Sorafenib Study Dosing in Patients With Pulmonary Arterial Hypertension PAH
Sponsor:
University of Chicago
Organization:
University of Chicago
Study Overview
Official Title:
Sorafenib Study Dosing in Patients With Pulmonary Arterial Hypertension PAH
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the safety and tolerability of sorafenib in patients with PAH already on existing therapy with a prostacyclin epoprostenol Flolan treprostinil Remodulin or iloprost alone or with or without sildenafil ViagraRevatio
Detailed Description:
Pulmonary arterial hypertension PAH is an angioproliferative vasculopathy resulting from abnormal endothelial and smooth muscle cell interactions Idiopathic and familial PAH formerly known as primary pulmonary hypertension occurs more often in women than in men with a median survival of 28 years if untreated and a mean age at diagnosis of 35 years The key features of this vasculopathy causes a progressive narrowing of the pulmonary artery and their branches resulting in right heart failure and death Proliferating endothelial cells obliterate medium-sized precapillary arteries thereby forming the characteristic plexiform lesions When combined with the expansion of both vascular smooth muscle cells and adventitial cells in pulmonary arteries these observations evoke comparisons to cancer pathobiology Currently FDA-approved therapies for PAH such as prostacyclins epoprostenol treprostinil and iloprost endothelin receptor blockers bosentan and phosphodiesterase inhibitors sildenafil all produce functional improvement 6 minute walk distance- 6MW with minimal change in hemodynamic measurements at cardiac catheterization Only epoprostenol has provided survival benefit with the 5-year survival remaining at 50 without demonstrable reversal of the vasculopathy Clearly there is a critical need for novel targets and therapies for PAH
In this protocol the principal investigator PI will leverage a large PAH referral practice with an established clinical database to assess the potential utility of kinase inhibitors as a new class of agents for protease-activated receptor PAR These drugs inhibit processes important to pathological blood vessel branching and growth and have been a focus for the internationally renowned University of Chicago Phase III trials unit in oncology led by Dr Mark Ratain Co-Investigator The University of Chicago has had a major role in the drug development of the recently 1205 FDA-approved drug sorafenib for advanced renal carcinoma Sorafenib inhibits Raf-1 kinase a regulator of endothelial apoptosis and inhibits angiogenesis growth factor receptors VEGFR-2 PDGFR-B and VEGFR-3
In this protocol the principal investigator PI will leverage a large PAH referral practice with an established clinical database to assess the potential utility of kinase inhibitors as a new class of agents for protease-activated receptor PAR These drugs inhibit processes important to pathological blood vessel branching and growth and have been a focus for the internationally renowned University of Chicago Phase III trials unit in oncology led by Dr Mark Ratain Co-Investigator The University of Chicago has had a major role in the drug development of the recently 1205 FDA-approved drug sorafenib for advanced renal carcinoma Sorafenib inhibits Raf-1 kinase a regulator of endothelial apoptosis and inhibits angiogenesis growth factor receptors VEGFR-2 PDGFR-B and VEGFR-3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None