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โ† Trials
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A Study to Evaluate Topical ATR04-484 for EGFRi-Associated Dermal Toxicity

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllAzitra Inc.
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In plain words

What the trial is, and whether it could suit you

The goal of this randomized clinical trial is to learn if topical treatment with ATR04-484 can treat skin rash in patients undergoing EGFR inhibitor (EGFRi) therapy. The primary goal of the study is to determine safety and tolerability of ATR04-484, and the secondary goal of the study is to assess efficacy signals of ATR04-484. Researchers will compare treatment of ATR04-484 to its vehicle. Participants will: * Apply ATR04-484 or vehicle daily for 28 days * Visit the clinic periodically for evaluation and sample collection

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults โ‰ฅ18 years of age * Currently treated with an FDA-approved EGFRi, KRASi, or MEKi (or other medications in the pathway, if approved by the Medical Monitor) for the treatment of cancer with or without concurrent chemotherapy, or for neurofibromatosis, and expected to continue treatment with the medication through the study treatment period * Has Grade 2 or 3 non-infected moderate to severe dermal toxicity affecting the face (the neck, chest, back and other areas may also be affected); Grade 1 toxicity may be permitted in up to 25% of enrolled patients Exclusion Criteria: * Significant skin disease other than EGFRi-related dermal toxicity * Treatment with topical mid- to high-potency topical corticosteroids, or topical antibiotics or antibacterial washes on the face, neck, chest, or back within 7 days prior to baseline; treatment with systemic antibiotics or systemic corticosteroids within 7 days prior to baseline * Residing with an immunocompromised person residing with them in the same dwelling from the baseline visit through 2 weeks after the treatment period
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What it tests

  • ATR04-484
  • Vehicle
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Where

6 sites
Genesis Cancer and Blood Institute
Hot Springs, United States
Yale University School of Medicine
New Haven, United States
NYU Langone
New York, United States
The Ohio State University
Gahanna, United States
MD Anderson
Houston, United States
Inova Schar Cancer
Fairfax, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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