NCT01006096

Brief Summary

The purpose of this study is to determine whether erlotinib is effective in the treatment of psoriasis.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2009

Completed
Last Updated

November 10, 2014

Status Verified

November 1, 2014

First QC Date

October 29, 2009

Last Update Submit

November 7, 2014

Conditions

Psoriasis

Keywords

Psoriasisdouble-blindrandomizedplacebo-controllederlotinibefficacy

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • 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

Study Arms (2)

Erlotinib

EXPERIMENTAL
Drug: erlotinib

Placebo tablets

PLACEBO COMPARATOR
Other: placebo tablet

Interventions

erlotinibDRUG

100mg tablet, once daily for 16 weeks

Also known as: Tarceva
Erlotinib
placebo tabletOTHER

placebo tablet (lactose), once daily for 16 weeks

Placebo tablets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of moderate to severe psoriasis
  • 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.

You may not qualify if:

  • Use of concurrent agents/therapies for psoriasis
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Related Publications (12)

  • Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007 Feb 22;445(7130):866-73. doi: 10.1038/nature05663.

    PMID: 17314973BACKGROUND

  • 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.

    PMID: 16014882BACKGROUND

  • Lacouture ME. Mechanisms of cutaneous toxicities to EGFR inhibitors. Nat Rev Cancer. 2006 Oct;6(10):803-12. doi: 10.1038/nrc1970.

    PMID: 16990857BACKGROUND

  • 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.

    PMID: 16792781BACKGROUND

  • 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.

    PMID: 7640880BACKGROUND

  • 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.

    PMID: 10583160BACKGROUND

  • 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.

    PMID: 10828317BACKGROUND

  • 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.

    PMID: 10909421BACKGROUND

  • 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.

    PMID: 18535184BACKGROUND

  • 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.

    PMID: 18446355BACKGROUND

  • 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.

    PMID: 18769609BACKGROUND

  • 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.

    PMID: 15370619BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

Erlotinib Hydrochloride

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Anne E Laumann, MBChB, MRCP (UK)

    Northwestern University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2009

First Posted

November 2, 2009

Last Updated

November 10, 2014

Record last verified: 2014-11

Locations

US(1)