Sorafenib for Patients With Extensive Keloids (NCT01425216) | Clinical Trial Compass
TerminatedPhase 2
Sorafenib for Patients With Extensive Keloids
Stopped: IND application was not approved by the US FDA - Project was never started
United States60 participantsStarted 2013-03
Plain-language summary
Treatment of keloid disorder is an area of unmet medical need. Current treatments for keloid partially address small and localized keloids, yet there are no wholly satisfactory or effective treatments for patients with extensive keloids. Such patients may benefit from effective systemic treatments.
Sorafenib has the potential to regulate the three known dysregulated biological pathways in keloid tissue.
Who can participate
Age range18 Years ā 50 Years
SexALL
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Inclusion criteria
ā. Clinical Diagnosis of a keloid.
ā. Presence of extensive keloid disease as defined in section 1.3
ā. Age 18 to 50
ā. A signed informed consent document (ICD)
ā. Able and willing to receive sorafenib
ā. Patients must have normal end organ and marrow function
Exclusion criteria
ā. Diastolic Blood pressure of 90 mm Hg or above
ā. History of any degree of hypertension, even medically controlled hypertension
ā. History of any form of cardiovascular disease or stroke
ā. History of any form of thromboembolic event
ā. History of renal dysfunction or proteinuria,
What they're measuring
1
Response Rate (RR) of extensive keloids to sorafenib. RR is the sum of Complete Remission (CR) and Partial Remission (PR) at 12 month after last dose of sorafenib.