A Phase II Study of ACZONE™ (Dapsone) Gel, 5% As a Treatment For Tarceva® (Erlotinib)Related Rash

NCT00343187 | Terminated Phase 2

• 1 other identifier: ACZ EGFR 01
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to evaluate the safety and preliminary efficacy of ACZONE in subjects treated with the HER1/EGFR inhibitor Tarceva (erlotinib) who develop a rash on the face

Conditions

Rash; Non-small-Cell Lung Cancer

Keywords

Tarceva; Rash; EGFR-1 Rash; erlotinib; Aczone; Dapsone; Non-small Cell Lung Cancer; subjects treated with Tarceva for non-small cell lung cancer (NSCLC) who subsequently develop a rash suspected to be related to Tarceva

Outcome Measures

Primary Outcomes (1)

• Safety: Adverse events; laboratory parameters; Vital signs; Pharmacokinetics

Secondary Outcomes (1)

• Efficacy: Lesion counts; Plaque area; % of FSA affected; Erythema Score; Pruritus VAS Score; CTCAE v3.0 Grade for rash; Proportion of subjects who have rash on the face that worsens to specific category.

Interventions

ACZONE (dapsone) Gel, 5% DRUG

Vehicle Control DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for the study, subjects must fulfill all of the following criteria:
• Be male or female ≥18 years of age (inclusive).
• Have been prescribed Tarceva as a single agent to treat locally advanced or metastatic NSCLC, after failing at least 1 prior chemotherapy regimen.
• Present with acute signs and symptoms of rash on the face that meet the following criteria:
• Are suspected to be related to Tarceva,
• Include at least 3 inflammatory lesions, and
• Are less than CTCAE Grade 3 in severity.
• Have an Eastern Co-operative Oncology Group (ECOG) performance status ≤2 and a life expectancy of at least 4 months.
• Sign an approved informed consent form for the study.
• Be willing to comply with the protocol.

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from the study:
• A skin examination reveals the presence of another skin disease and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the face that, in the study physician's opinion, would confound the evaluation of the rash.
• A diagnosis of G6PD deficiency, defined as having a G6PD value below the lower limit of normal.
• A diagnosis of anemia, defined as hemoglobin \<9.5 g/dL.
• Undergoing any current therapy for NSCLC other than Tarceva.
• Prior treatment with Iressa, Erbitux, or any experimental HER1/EGFR inhibitor.
• Treatment with topical antibiotics, topical steroids, and other topical treatments on the face within 14 days of Day 0 (start of ACZONE/placebo study treatment).
• Treatment with any systemic antibiotics within 7 days of Day 0 (start of ACZONE/placebo study treatment).
• Treatment with any systemic medication or therapy known to affect anti-inflammatory responses within 30 days prior to Day 0 (start of ACZONE/placebo study treatment). These medications include, but are not limited to, oral corticosteroids, cyclosporine, and methotrexate. Short-term treatment with non-steroidal anti-inflammatory drugs (NSAIDs) before the study for non-rash related conditions is acceptable, provided that exposure is limited to ≤7 days per course. Chronic low-dose aspirin use is also acceptable.
• Active participation in an experimental therapy study or received experimental therapy within 30 days of Day 0 (start of ACZONE/placebo study treatment).
• A history of hypersensitivity to dapsone, sulfamethoxazole, trimethoprim, parabens, or any component of ACZONE.
• A poor medical risk because of other systemic diseases or active uncontrolled infections.
• Women who: are lactating; have a positive pregnancy test at Day 0, or; if sexually active and menstruating, are not practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD); oral, dermal ("patch"), implanted or injected contraceptives; tubal ligation or hysterectomy (medical documentation required); and/or barrier methods with spermicide. A surgically sterile partner is not considered an adequate method of birth control.

Sponsors & Collaborators

• Allergan: lead

Study Sites (3)

Northwestern University Robert H. Lurie Comprehensive Cancer Center

Chicago, Illinois, 60611-2941, United States

Location

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Related Links

• QLT Inc. Home Page

MeSH Terms

Conditions

Exanthema; Carcinoma, Non-Small-Cell Lung

Interventions

Dapsone; Gels

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Steven Garrett, MS, DDS

  QLT USA, Inc

  STUDY DIRECTOR

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: June 20, 2006
• First Posted: June 22, 2006
• Study Start: June 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: May 30, 2011

Record last verified: 2011-05

Locations

US (3)