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IND not obtained
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| Name | Class |
|---|---|
| OSI Pharmaceuticals | INDUSTRY |
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The purpose of this study is to determine whether erlotinib is effective in the treatment of psoriasis.
Psoriasis vulgaris is a disease that affects 25 million people in North America and Europe. It often presents in late adolescence and usually persists for life. Current therapies target specific immune molecules that are implicated in the cause of this disease. For example, biologic agents that are used in severe psoriasis are aimed at inflammatory mediators. These therapies have been proven to be effective but also have their limitations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erlotinib | Experimental |
| |
| Placebo tablets | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erlotinib | Drug | 100mg tablet, once daily for 16 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine efficacy of erlotinib in treatment of moderate to severe psoriasis measured by the Psoriasis Area and Severity Index (PASI) and the Physician's Global Assessment (PGA). | week 4, 8, 12, 16, and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the rate of dose reduction or interruption as a result of adverse events. | week 4, 8, 12, 16, and 24 | |
| To determine quality of life using the Dermatology Life Quality Index (DLQI). | week 4, 8, 12, 16, and 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne E Laumann, MBChB, MRCP (UK) | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine Department of Dermatology | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17314973 | Background | Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007 Feb 22;445(7130):866-73. doi: 10.1038/nature05663. | |
| 16014882 | Background | 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. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo tablet | Other | placebo tablet (lactose), once daily for 16 weeks |
|
| 16990857 | Background | Lacouture ME. Mechanisms of cutaneous toxicities to EGFR inhibitors. Nat Rev Cancer. 2006 Oct;6(10):803-12. doi: 10.1038/nrc1970. |
| 16792781 | Background | 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. |
| 7640880 | Background | 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. |
| 10583160 | Background | 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. |
| 10828317 | Background | 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. |
| 10909421 | Background | 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. |
| 18535184 | Background | 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. |
| 18446355 | Background | 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. |
| 18769609 | Background | 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. |
| 15370619 | Background | 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. |