3 Participants Needed

Ruxolitinib for Skin Cancer

Recruiting at 2 trial locations
RC
RN
Overseen ByResearch Nurse Navigator
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Columbia University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

In this open-label, multicenter, Phase II study, the investigators propose to evaluate the efficacy of ruxolitinib, an orally administered inhibitor of JAK1/2, in solid organ transplant recipients with advanced cSCC. In a safety lead-in of 6 patients, subjects will receive ruxolitinib 15mg twice daily (BID). After 4 weeks, if dose-limiting toxicities (DLT) are observed in 1 or fewer patients, the study will enter stage 1 of the Simon two-stage design where all subsequent patients will receive a starting dose of ruxolitinib 15mg BID. If more than 1 DLTs are observed, another cohort of 6 patients will be treated at a dose of 10mg BID. If less than 2 DLTs are observed at the new dose of 10mg, then the study will proceed to stage I using this dose; otherwise the study will stop.

Who Is on the Research Team?

AW

Alexander Wei, MD

Principal Investigator

Associate Professor of Medicine at the Columbia University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced skin cancer (cSCC) after a solid organ transplant. They must have measurable disease, be in fair health (KPS ≥60%, ECOG ≤2), and have recovered from previous treatments. A biopsy may be required, they can't be pregnant, must take oral meds well, haven't used JAK inhibitors before, and their organs must work properly.

Inclusion Criteria

I have had an organ transplant and am on immunosuppressants.
Negative pregnancy test for women of child bearing potential
I can take pills by mouth.
See 8 more

Exclusion Criteria

I have been treated with a JAK inhibitor before.
I am not HIV-positive or on antiretroviral therapy.
I haven't had major surgery in the last 4 weeks, except for procedures to place a vascular access device.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Safety Lead-in

In a safety lead-in of 6 patients, subjects will receive 15mg of ruxolitinib twice daily (BID) for 4 weeks to assess dose-limiting toxicities.

4 weeks
2 visits (in-person) on Day 1 and Day 15

Treatment

Participants receive ruxolitinib 15mg BID in a Simon two-stage design, with regular safety assessments.

24 weeks
1 visit (in-person) every cycle starting from cycle 3

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term Follow-up

Participants are monitored for progression-free survival and overall survival.

Up to 17 months

What Are the Treatments Tested in This Trial?

Interventions

  • Ruxolitinib
Trial Overview The study tests Ruxolitinib's effectiveness on cSCC in transplant recipients. Initially, patients get 15mg twice daily; if side effects are manageable, the dose continues or reduces to 10mg based on early results. It's an open-label Phase II trial using Simon two-stage design to adjust dosing.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: RuxolitinibExperimental Treatment1 Intervention

Ruxolitinib is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Jakafi for:
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Approved in European Union as Jakavi for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials
1,529
Recruited
2,832,000+

Incyte Corporation

Industry Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

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