Sorafenib for Patients With Extensive Keloids

NCT01425216 | Terminated Phase 2

• 1 other identifier: Tirgan 11-05
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Keloids

Keywords

Keloid; Patient who have extensive or massive keloids

Outcome Measures

Primary Outcomes (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.

  The primary objective of this trial is to demonstrate the efficacy of sorafenib in patients with extensive keloids.

  12 months

Secondary Outcomes (1)

• The secondary endpoint of this trial is to demonstrate the rate of AE and SAE following exposure to sorafenib measured while on treatment as well as at 1 year after the last dose of sorafenib.

  12 months

Study Arms (1)

Sorafenib arm

EXPERIMENTAL

All patients will be treated with sorafenib.

Drug: Sorafenib

Interventions

Sorafenib DRUG

Treatment will be administered on an outpatient basis. All patients will keep a drug diary in order to record compliance with their drug regime. Sorafenib will be taken orally. Maximum length of treatment is 6 months. Starting dose of sorafenib is 200 mg three times per week for one month. In absence of Grade 2 toxicity, the dose will be increased on a monthly basis and will stop at 400 mg twice daily.

Also known as: Nexavar (sorafenib)

Sorafenib arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tirgan, Michael H., M.D.: lead

Study Sites (1)

Michael H. Tirgan, MD

New York, New York, 10023, United States

Location

MeSH Terms

Conditions

Keloid

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Michael H Tirgan, MD

  St. Luke's Roosevelt Hospital Center, New York City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: August 29, 2011
• Study Start: March 1, 2013
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

US (1)