Clinical trial · Interventional
Ketoconazole in Treating Participants With Ongoing EGFR Inhibitor-Induced Rash
Double-Blinded, Placebo-Controlled Trial to Explore the Anti-Androgen, Ketoconazole, for Treating Patients With an Ongoing Epidermal Growth Factor Receptor (EGFR) Inhibitor-Induced Rash
NCT03471364CI-TRIAL-00096405completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This early phase I trial studies the side effects of ketoconazole and how well it works in treating participants with ongoing EGFR inhibitor-induced rash. Ketoconazole may reduce the symptoms related to EGFR inhibitor therapy and improve EGFR inhibitor-induced rash.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ketoconazole | Drug | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Placebo Administration | Other | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (ketoconazole)
- description
- Participants apply ketoconazole topically BID on days 1-28.
- interventionNames
- Drug: Ketoconazole
- Other: Laboratory Biomarker Analysis
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Participants apply placebo topically BID on days 1-28.
- interventionNames
- Other: Laboratory Biomarker Analysis
- Other: Placebo Administration
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient has developed a rash or symptoms of a rash (cutaneous burning) characteristic of an EGFR inhibitor (health-care provider report of the rash with no other documentation is permitted) * Patient is anticipated to continue for at least 28 days with an EGFR inhibitor or restart =\< 14 days of registration and continue for at least 28 days * Mayo only: Patient is willing to provide a skin biopsy for correlative research; Note: Can be waived with permission of study chair (documentation such as an email must be provided) * Patient must complete baseline quality of life (QOL) packet Exclusion Criteria: * Patient has a prior allergy or intolerance of ketoconazole * Patient has an allergy or intolerance to sulfites
References
Publications (0)
Data not yet available
No reference posted for this study.