Combination of ivermectin with standard skin-protective care for daraxonrasib-related skin toxicity in pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 2 interventional trial compares the addition of ivermectin to standard of care prophylaxis for daraxonrasib-induced skin toxicity in advanced pancreatic ductal adenocarcinoma. Participants are randomized to receive ivermectin plus SOCP or SOCP alone, with quality of life assessed through patient questionnaires. The study includes topical and systemic agents such as minocycline, hypochlorous acid, hydrocortisone cream, triamcinolone cream, and clobetasol as part of the management. Outcomes focus on skin toxicity response and patient-reported quality of life, with safety monitoring throughout treatment. Enrollment is limited to adults with daraxonrasib-eligible disease and without active infections or concomitant investigational drugs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must have advanced pancreatic ductal adenocarcinoma with intent to daraxonrasib as standard of care monotherapy
* Female or male aged 18 years and older at the time of enrollment.
* Not pregnant and not nursing.
* No active infection requiring parenteral antibiotic(s).
* Patients have no intent to receive other anti-cancer therapy beyond daraxonrasib
* No history of allergic reaction to the study agent(s), compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients).
* Patients who are able to understand and willing to sign the written informed consent form or patients who have impaired decision-making capacity but have a legally authorized representative who can consent on their behalf are eligible. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.

Exclusion Criteria:

* Concurrent use of another investigational drug or device for the daraxonrasib-induced skin toxicity (i.e., outside of study treatment) during, or within 4 weeks of study treatment.
* Patients receiving prednisone 10 mg/day or higher (or equivalent) at the time of randomization for indications other than daraxonrasib skin toxicity management.
* Patients receiving tetracyclines, ivermectin or other systemic medication that could mask daraxonrasib rash development.
* Pregnancy or planned pregnancy during the study period.
* Documented allergy to oral ivermectin and / or minocycline
* Any condition which, in the investigator's opinion, makes the patient unsuitable for trial participation.

Where it's running

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (Consent Only)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (Consent Only)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (Consent Only)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Allison Gordon, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Allison Gordon, MD
• Email: gordona3@mskcc.org
• Phone: 646-608-2339

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.