NCT00108121

Brief Summary

The purpose of this study is to determine whether topical application of PEP005 is safe for the treatment of nodular basal cell carcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

10 active sites

Status
completed

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

Study Start

First participant enrolled

March 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 14, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 15, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 19, 2015

Status Verified

January 1, 2015

Enrollment Period

1.2 years

First QC Date

April 14, 2005

Last Update Submit

January 16, 2015

Conditions

Basal Cell Carcinoma

Keywords

Nodular basal cell carcinomabasal cell carcinomanBCCBCCPEP005TopicalDermatology

Outcome Measures

Primary Outcomes (1)

  • Safety

Secondary Outcomes (1)

  • Resolution of nodular basal cell carcinoma

Interventions

PEP005DRUG

Eligibility Criteria

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

You may qualify if:

  • Male or female patients at least 18 years of age
  • One nBCC on the arm, shoulder, chest, face, neck, abdomen, leg, back or scalp suitable for surgical excision
  • Histological confirmation of nBCC based on the central dermatopathologist's evaluation of the punch biopsy
  • Longest pre- and post-biopsy diameter of the nBCC lesion between 4 mm and 15 mm
  • Maximum thickness of 4 mm of the nBCC lesion
  • Laboratory values within the reference ranges as defined by the central laboratory or "out of range" test results that are clinically acceptable to the Investigator
  • Ability to follow study instructions and likely to complete all study requirements
  • Written informed consent
  • Male patients with a female partner of childbearing potential must use an approved form of contraception during the study and for 4 weeks after the last visit
  • Agreement from the patient to allow photographs of all selected lesions (including the face) to be taken and used as part of the study data package

You may not qualify if:

  • Location of the outside margin of the anticipated treatment area of the nBCC selected for treatment:
  • within 10 cm of a malignant lesion that will require treatment during the study
  • within 5 cm of an incompletely healed wound
  • within 2 cm of a pre-malignant lesion (e.g. actinic keratosis lesion)
  • within 2 cm of the open eyelid margins
  • within 1 cm of a scar or an area previously treated with surgical excision
  • on the lips
  • on the breast
  • on the hand or foot
  • in a skin crease
  • nBCC lesion selected for treatment requiring Mohs micrographic surgery
  • Presence of known or suspected metastatic disease
  • Histological evidence of actinic keratoses or sBCC (superficial basal cell carcinoma) in the screening visit biopsy sample
  • Histological evidence of BCC with micro-nodular features or squamous metaplasia, sclerosing BCC (i.e. desmoplastic or morphoeic), or BCC with perineural involvement in the screening visit biopsy sample
  • History of recurrence of the nBCC lesion
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Southderm Pty Ltd

Sydney, New South Wales, 2010, Australia

Location

St George Dermatology & Skin Cancer Centre

Sydney, New South Wales, 2217, Australia

Location

Siller Medical

Brisbane, Queensland, 4000, Australia

Location

South East Dermatology

Brisbane, Queensland, 4152, Australia

Location

The Skin Centre

Gold Coast, Queensland, 4217, Australia

Location

13 Eleanor St

Footscray, Victoria, 3011, Australia

Location

Skin and Cancer Foundation

Melbourne, Victoria, 3052, Australia

Location

Monash Medical Centre

Melbourne, Victoria, 3168, Australia

Location

Fremantle Dermatology

Fremantle, Western Australia, 6160, Australia

Location

St John of God Dermatology

Subiaco, Western Australia, 6008, Australia

Location

Related Publications (2)

  • Rosen RH, Katsamas J, Ogbourne SM, Welburn P. Early phase clinical development of PEP005 topical gel for basal cell carcinoma. 21st World Congress of Dermatology, Buenos Aires, 2007. 2007: Poster no. P5755 (1 p.)

    RESULT

  • Rosen RH, Freeman M, Siller G, Katsamas J, Ogbourne SM. Safety and efficacy of PEP005 Topical Gel for the treatment of nodular and superficial forms of basal cell carcinoma. Summer Academy, American Academy of Dermatology meeting, New York, NY, 2007. 2007: Poster no. P1502

    RESULT

MeSH Terms

Conditions

Carcinoma, Basal Cell

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Basal Cell

Study Officials

  • Greg Siller

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 14, 2005

First Posted

April 15, 2005

Study Start

March 1, 2005

Primary Completion

May 1, 2006

Study Completion

May 1, 2006

Last Updated

January 19, 2015

Record last verified: 2015-01

Locations

AU(10)