Sorafenib for Patients With Extensive Keloids

• Status: Terminated
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tirgan, Michael H., M.D.
• Treatments: Niacinamide; Sorafenib

Criteria

Inclusion Criteria:

1. Clinical Diagnosis of a keloid.

2. Presence of extensive keloid disease as defined in section 1.3

3. Age 18 to 50

4. A signed informed consent document (ICD)

5. Able and willing to receive sorafenib

6. 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 Criteria:

1. Diastolic Blood pressure of 90 mm Hg or above

2. History of any degree of hypertension, even medically controlled hypertension

3. History of any form of cardiovascular disease or stroke

4. History of any form of thromboembolic event

5. History of renal dysfunction or proteinuria,

6. History of any form of liver dysfunction

7. History of recent (past 12 month) or planned (next 9 months) major surgery,

8. Men and women who plan to have children within 3 months of their last treatment

9. Psychological Illness that may result in non compliance with treatment

10. Patients receiving any other investigational agents.

11. Patients with a history of serious allergic reactions to eggs (sorafenib is formulated using egg phospholipids).

12. HIV-positive patients receiving combination anti-retroviral therapy are excluded because of possible pharmacokinetic interactions with the investigational agent.

13. Patients who cannot swallow pills for whatever reason will be excluded.

14. Patients having any history or current evidence of a bleeding diathesis.

15. Patients who are taking, or have taken anticoagulants in past 12 months for any reason.

16. 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