Status:
TERMINATED
A Phase II Study of ACZONE™ (Dapsone) Gel, 5% As a Treatment For Tarceva® (Erlotinib)Related Rash
Lead Sponsor:
Allergan
Conditions:
Rash
Non-small-Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Detailed Description
This will be a randomized, double-blind, parallel design study in subjects treated with Tarceva for non-small cell lung cancer (NSCLC) who subsequently develop a rash suspected to be related to Tarcev...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2007
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00343187
Start Date
June 1 2006
End Date
July 1 2007
Last Update
May 30 2011
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Northwestern University Robert H. Lurie Comprehensive Cancer Center
Chicago, Illinois, United States, 60611-2941
2
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
3
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111