Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Erlotinib
erlotinib
100mg tablet, once daily for 16 weeks
Placebo tablets
placebo tablet
placebo tablet (lactose), once daily for 16 weeks
Interventions
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erlotinib
100mg tablet, once daily for 16 weeks
placebo tablet
placebo tablet (lactose), once daily for 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have documented moderate to severe psoriasis by the Physician's Global Assessment (PGA) and the Psoriasis Area Severity Index (PASI)
* Must be able to swallow tablets
* Must be able to provide written informed consent
* Subjects with reproductive potential (menopausal for less than 1 year and not surgically sterilized) must practice effective contraceptive measures throughout the study and thirty days after discontinuation of study drug. Women of childbearing potential must provide negative pregnancy test (serum or urine) within 14 days prior to randomization.
Exclusion Criteria
* Bilirubin \> 3 X ≥ ULN or moderate to severe hepatic impairment
* Pregnant or breast-feeding females
* Subjects currently receiving other anticancer treatments
* Subjects currently receiving other biologic treatments
* Subjects currently receiving blood thinners (warfarin or heparin)
* Subjects who currently smoke
* Subjects with other skin disease which in the opinion of the investigator, would inhibit the ability to use the PGA and PASI evaluation methods
18 Years
ALL
No
Sponsors
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OSI Pharmaceuticals
INDUSTRY
Northwestern University
OTHER
Responsible Party
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Northwestern University
Principal Investigators
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Anne E Laumann, MBChB, MRCP (UK)
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University Feinberg School of Medicine Department of Dermatology
Chicago, Illinois, United States
Countries
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References
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Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007 Feb 22;445(7130):866-73. doi: 10.1038/nature05663.
Shepherd FA, Rodrigues Pereira J, Ciuleanu T, Tan EH, Hirsh V, Thongprasert S, Campos D, Maoleekoonpiroj S, Smylie M, Martins R, van Kooten M, Dediu M, Findlay B, Tu D, Johnston D, Bezjak A, Clark G, Santabarbara P, Seymour L; National Cancer Institute of Canada Clinical Trials Group. Erlotinib in previously treated non-small-cell lung cancer. N Engl J Med. 2005 Jul 14;353(2):123-32. doi: 10.1056/NEJMoa050753.
Lacouture ME. Mechanisms of cutaneous toxicities to EGFR inhibitors. Nat Rev Cancer. 2006 Oct;6(10):803-12. doi: 10.1038/nrc1970.
Wierzbicka E, Tourani JM, Guillet G. Improvement of psoriasis and cutaneous side-effects during tyrosine kinase inhibitor therapy for renal metastatic adenocarcinoma. A role for epidermal growth factor receptor (EGFR) inhibitors in psoriasis? Br J Dermatol. 2006 Jul;155(1):213-4. doi: 10.1111/j.1365-2133.2006.07299.x. No abstract available.
Ben-Bassat H, Vardi DV, Gazit A, Klaus SN, Chaouat M, Hartzstark Z, Levitzki A. Tyrphostins suppress the growth of psoriatic keratinocytes. Exp Dermatol. 1995 Apr;4(2):82-8. doi: 10.1111/j.1600-0625.1995.tb00227.x.
Powell TJ, Ben-Bassat H, Klein BY, Chen H, Shenoy N, McCollough J, Narog B, Gazit A, Harzstark Z, Chaouat M, Levitzki R, Tang C, McMahon J, Shawver L, Levitzki A. Growth inhibition of psoriatic keratinocytes by quinazoline tyrosine kinase inhibitors. Br J Dermatol. 1999 Nov;141(5):802-10. doi: 10.1046/j.1365-2133.1999.03152.x.
Ben-Bassat H, Klein BY. Inhibitors of tyrosine kinases in the treatment of psoriasis. Curr Pharm Des. 2000 Jun;6(9):933-42. doi: 10.2174/1381612003400182.
Ben-Bassat H, Levitzki A. Inhibitors of tyrosine kinases in the treatment of psoriasis. Isr Med Assoc J. 2000 Jul;2 Suppl:69-73. No abstract available.
Halin C, Fahrngruber H, Meingassner JG, Bold G, Littlewood-Evans A, Stuetz A, Detmar M. Inhibition of chronic and acute skin inflammation by treatment with a vascular endothelial growth factor receptor tyrosine kinase inhibitor. Am J Pathol. 2008 Jul;173(1):265-77. doi: 10.2353/ajpath.2008.071074. Epub 2008 Jun 5.
Forsberg S, Ostman A, Rollman O. Regeneration of human epidermis on acellular dermis is impeded by small-molecule inhibitors of EGF receptor tyrosine kinase. Arch Dermatol Res. 2008 Oct;300(9):505-16. doi: 10.1007/s00403-008-0853-2. Epub 2008 Apr 30.
Neyns B, Meert V, Vandenbroucke F. Cetuximab treatment in a patient with metastatic colorectal cancer and psoriasis. Curr Oncol. 2008 Aug;15(4):196-7. doi: 10.3747/co.v15i4.228.
Trivin F, Boucher E, Raoul JL. Complete sustained regression of extensive psoriasis with cetuximab combination chemotherapy. Acta Oncol. 2004;43(6):592-3. doi: 10.1080/02841860410020211. No abstract available.
Other Identifiers
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MEL-041509
Identifier Type: -
Identifier Source: org_study_id