Status:
TERMINATED
Sorafenib for Patients With Extensive Keloids
Lead Sponsor:
Tirgan, Michael H., M.D.
Conditions:
Keloids
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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...
Detailed Description
Dysregulation of several intracellular pathways have been reported by various investigators. \[A\] Dysregulated apoptosis pathway: p53 mutations have been found in both hypertrophic scar and keloids ...
Eligibility Criteria
Inclusion
- Clinical Diagnosis of a keloid.
- Presence of extensive keloid disease as defined in section 1.3
- Age 18 to 50
- A signed informed consent document (ICD)
- Able and willing to receive sorafenib
- Patients must have normal end organ and marrow function
- Women of child-bearing potential must have a negative pregnancy test during screening. The effects of sorafenib on the developing human fetus are unknown. For this reason, women of child-bearing potential, and men, must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and three months beyond the last dose of sorafenib. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
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Exclusion
- Diastolic Blood pressure of 90 mm Hg or above
- History of any degree of hypertension, even medically controlled hypertension
- History of any form of cardiovascular disease or stroke
- History of any form of thromboembolic event
- History of renal dysfunction or proteinuria,
- History of any form of liver dysfunction
- History of recent (past 12 month) or planned (next 9 months) major surgery,
- Men and women who plan to have children within 3 months of their last treatment
- Psychological Illness that may result in non compliance with treatment
- Patients receiving any other investigational agents.
- Patients with a history of serious allergic reactions to eggs (sorafenib is formulated using egg phospholipids).
- HIV-positive patients receiving combination anti-retroviral therapy are excluded because of possible pharmacokinetic interactions with the investigational agent.
- Patients who cannot swallow pills for whatever reason will be excluded.
- Patients having any history or current evidence of a bleeding diathesis.
- Patients who are taking, or have taken anticoagulants in past 12 months for any reason.
- Pregnancy and Breast Feeding Pregnant women are excluded from this study because sorafenib has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with sorafenib, breastfeeding is not allowed during the course of the study.
- Female patients will be advised not to get pregnant during the first 3 months from last administered dose of sorafenib. Men will be advised to continue using barrier method contraception and not father a child during the first 3 months from last administered dose of sorafenib
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01425216
Start Date
March 1 2013
End Date
March 1 2013
Last Update
October 18 2016
Active Locations (1)
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1
Michael H. Tirgan, MD
New York, New York, United States, 10023