Pancreatic CancerPhase 2NCT07895498
A Study of Standard of Care Drugs With or Without Ivermectin for Daraxonrasib-Induced Skin Toxicity in People With Pancreatic Cancer
A Phase 2 study testing Minocycline, Hypochlorous Acid and Hydrocortison cream in people with Pancreatic Cancer and Skin Toxicities, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Skin Toxicities
- What is being tested?
- Minocycline, Hypochlorous Acid and Hydrocortison cream
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 7 sitesUnited States
- Study dates
- 16 Oct 2026to 16 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Eileen O'Reilly, MD contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Allison Gordon, MD, 646-608-2339
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Consent Only)
Commack, New York, 11725
Allison Gordon, MD, 646-608-2339
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Allison Gordon, MD, 646-608-2339
- Recruiting
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748
Allison Gordon, MD, 646-608-2339
- Recruiting
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, 07645
Allison Gordon, MD, 646-608-2339
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Allison Gordon, MD, 646-608-2339
- Recruiting
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, 11553
Allison Gordon, MD, 646-608-2339
About this study
Official title: A Randomized, Open-Label Study of Standard of Care Prophylaxis Versus Standard of Care Prophylaxis Plus Ivermectin for the Prevention of Daraxonrasib-Induced Skin Toxicity in Patients With Metastatic Pancreatic Cancer
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.
- Conditions
- Pancreatic Cancer, Skin Toxicities
- Being tested
- Minocycline, Hypochlorous Acid, Hydrocortison cream, Triamcinolone (TAC) 0.1% cream, Clobetasol
- Keywords
- Ivermectin, Daraxonrasib, 26-384
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Minocycline 100mg PO twice daily (or doxycycline alternative)
Hypochlorous AcidDrug
Face: Hypochlorous acid solution applied every morning
Hydrocortison creamDrug
Face: Hydrocortisone 2.5% cream (or equivalent) applied twice daily
Triamcinolone (TAC) 0.1% creamDrug
Trunk: Triamcinolone 0.1% cream (or equivalent) applied twice daily
ClobetasolDrug
Scalp: Clobetasol propionate 0.05% solution (or equivalent) applied twice daily
PhotoprotectionOther
Broad-spectrum sunscreen (SPF 30 or higher) applied daily to sun- exposed areas
IvermectinDrug
Ivermectin 200mcg/kg orally weekly PLUS
| Study group | Role | What they receive |
|---|---|---|
| SOCP alone | Active comparator | Minocycline Face: Hypochlorous acid solution Face: Hydrocortisone Trunk: Triamcinolone Scalp: Clobetasol propionate Photoprotection: Broad-spectrum sunscreen Receives: Drug: Minocycline; Drug: Hypochlorous Acid; Drug: Hydrocortison cream; Drug: Triamcinolone (TAC) 0.1% cream; Drug: Clobetasol; Other: Photoprotection |
| Ivermectin 200 mcg/kg orally weekly plus SOCP | Experimental | Ivermectin 200mcg/kg orally weekly PLUS SOCP above as in Arm A Receives: Drug: Minocycline; Drug: Hypochlorous Acid; Drug: Hydrocortison cream; Drug: Triamcinolone (TAC) 0.1% cream; Drug: Clobetasol; Other: Photoprotection; Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
pustular drug eruption assessed
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.
Measured: Day 56 ± 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start16 Oct 2026
- Primary completion16 Oct 2028 (estimated)
- Study completion16 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allison Gordon, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895498
- Sponsor's protocol ID
- 26-384
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study of Standard of Care Prophylaxis Versus Standard of Care Prophylaxis Plus Ivermectin for the Prevention of Daraxonrasib-Induced Skin Toxicity in Patients With Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07895498
- Acronym / sponsor ID
- 26-384
- Conditions
- Pancreatic Cancer, Skin Toxicities
- Keywords
- Ivermectin, Daraxonrasib, 26-384
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 16 Oct 2026 (actual)
- Primary completion
- 16 Oct 2028 (estimated)
- Study completion
- 16 Oct 2028 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOCP alone | Active comparator | Drug: Minocycline, Drug: Hypochlorous Acid, Drug: Hydrocortison cream, Drug: Triamcinolone (TAC) 0.1% cream, Drug: Clobetasol, Other: PhotoprotectionMinocycline Face: Hypochlorous acid solution Face: Hydrocortisone Trunk: Triamcinolone Scalp: Clobetasol propionate Photoprotection: Broad-spectrum sunscreen |
| Ivermectin 200 mcg/kg orally weekly plus SOCP | Experimental | Drug: Minocycline, Drug: Hypochlorous Acid, Drug: Hydrocortison cream, Drug: Triamcinolone (TAC) 0.1% cream, Drug: Clobetasol, Other: Photoprotection, Drug: IvermectinIvermectin 200mcg/kg orally weekly PLUS SOCP above as in Arm A |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineMinocycline 100mg PO twice daily (or doxycycline alternative) | Drug | Ivermectin 200 mcg/kg orally weekly plus SOCP, SOCP alone |
| Hypochlorous AcidFace: Hypochlorous acid solution applied every morning | Drug | Ivermectin 200 mcg/kg orally weekly plus SOCP, SOCP alone |
| Hydrocortison creamFace: Hydrocortisone 2.5% cream (or equivalent) applied twice daily | Drug | Ivermectin 200 mcg/kg orally weekly plus SOCP, SOCP alone |
| Triamcinolone (TAC) 0.1% creamTrunk: Triamcinolone 0.1% cream (or equivalent) applied twice daily | Drug | Ivermectin 200 mcg/kg orally weekly plus SOCP, SOCP alone |
| ClobetasolScalp: Clobetasol propionate 0.05% solution (or equivalent) applied twice daily | Drug | Ivermectin 200 mcg/kg orally weekly plus SOCP, SOCP alone |
| PhotoprotectionBroad-spectrum sunscreen (SPF 30 or higher) applied daily to sun- exposed areas | Other | Ivermectin 200 mcg/kg orally weekly plus SOCP, SOCP alone |
| IvermectinIvermectin 200mcg/kg orally weekly PLUS | Drug | Ivermectin 200 mcg/kg orally weekly plus SOCP |
Primary outcome
pustular drug eruption assessed
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eileen O'Reilly, MD contact
Allison Gordon, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minocycline, Hypochlorous Acid and Hydrocortison cream in people with Pancreatic Cancer and Skin Toxicities, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Gordon, MD (646-608-2339, gordona3@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pustular drug eruption assessed (time frame: Day 56 ± 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.