Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT01299220
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age and older at the time of study enrollment.
* Started routine clinical, palliative, or experimental (off-label) treatment with erlotinib for solid tumors and have developed Grade 2 or higher skin toxicity based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.02.
* Failed therapy with a two-week course of antibiotic (doxycycline 100 mg twice daily, or cephalexin 250 mg twice daily in patients allergic to doxycycline).
* Willing and able to provide verbal and written informed consent
* If reproductive potential, both males and females,must practice effective contraceptive measures throughout the study. Women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to enrollment.
Exclusion Criteria:
* Pregnant or breast-feeding females.
* Known or suspected sensitivity to study medication.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 3 or worse.
* Treatment with a non-approved or investigational drug (with the exception of erlotinib used in an experimental setting) within 30 days prior to Day 1 of study treatment.
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated)for treatment of either a psychiatric or physical (e.g., infectious) illness.
* Bilirubin greater than or equal to three times the upper limit of normal. Sexually active women of childbearing potential must use an effective method of birth
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01299220
Study Brief:
Protocol Section:
NCT01299220