Pancreatic Cancer, Skin Toxicities
Conditions
Keywords
Ivermectin, Daraxonrasib, 26-384
Brief summary
The researchers are doing this study to find out whether the combination of ivermectin and standard of care prophylaxis (SOCP; drugs given to prevent the development of a disease or condition) is an effective treatment approach for people with skin side effects caused by daraxonrasib treatment (daraxonrasib-induced skin toxicity). The researchers will compare the combination of ivermectin and SOCP with SOCP alone to see which treatment approach is more effective. The researchers will also look at how the study treatments impact participants' quality of life. The researchers will measure quality of life by having participants complete questionnaires.
Interventions
DRUGMinocycline
Minocycline 100mg PO twice daily (or doxycycline alternative)
Face: Hypochlorous acid solution applied every morning
Face: Hydrocortisone 2.5% cream (or equivalent) applied twice daily
Trunk: Triamcinolone 0.1% cream (or equivalent) applied twice daily
DRUGClobetasol
Scalp: Clobetasol propionate 0.05% solution (or equivalent) applied twice daily
OTHERPhotoprotection
Broad-spectrum sunscreen (SPF 30 or higher) applied daily to sun- exposed areas
DRUGIvermectin
Ivermectin 200mcg/kg orally weekly PLUS
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pustular drug eruption assessed | Day 56 ± 3 days | using the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. Rash severity will be categorized into four ordered levels (grade 0, grade 1, grade 2, and grade 3), where lower grades indicate less severe disease involvement. |
Countries
United States
Contacts
CONTACTAllison Gordon, MD
CONTACTEileen O'Reilly, MD
PRINCIPAL_INVESTIGATORAllison Gordon, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed