Study of Ruxolitinib in Solid Organ Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT04807777|
Recruitment Status : Recruiting
First Posted : March 19, 2021
Last Update Posted : July 1, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Advanced Cutaneous Squamous Cell Carcinoma||Drug: Ruxolitinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multi-Center Phase II Study of Ruxolitinib in Solid Organ Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma|
|Actual Study Start Date :||July 8, 2021|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||May 2023|
In a safety lead-in of 6 patients, subjects will receive 15mg of ruxolitinib 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.
Subjects will have regularly scheduled study visits at the clinical site on Day 1 and Day 15 (± 3 days) of the first 2 cycles, then on Day 1 (± 3 days) of every subsequent cycle (starting cycle 3), where safety assessments, including laboratory assessments, vital signs, and physical examinations will be performed.
Ruxolitinib will be administered orally twice daily during the entirety of each 28-day cycle.
Other Name: JAKAVI
- Overall Response Rate (ORR) [ Time Frame: within the first 24 weeks of the start of study therapy ]The primary endpoint is the overall response rate as defined as the best response, confirmed at ≥4 weeks, within the first 24 weeks of the start of study therapy, using RECIST v1.1 criteria.
- Progression-Free Survival (PFS) [ Time Frame: Up to 36 months ]Progression-free survival (PFS) (time alive without advanced cutaneous squamous cell carcinoma (cSCC) probabilities will be estimated
- Overall Survival (OS) [ Time Frame: Up to 36 months ]The length of time from the start of treatment that subjects with the disease are still alive.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Histopathologically confirmed diagnosis of metastatic advanced cutaneous squamous cell carcinoma.
- History of solid-organ transplant requiring immunosuppression
- Age ≥ 18 yrs
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
- Karnofsky Performance Status Scale (KPS) ≥60%, Eastern Cooperative Oncology Group (ECOG) ≤2
- No prior Janus kinase (JAK) Inhibitor therapy
- Adequate organ function
- All clinically significant toxicities from prior systemic therapy must be ≤ Grade 1 (with the exception of alopecia, and peripheral neuropathy, which may be ≤ grade 2).
- Subjects must agree to undergo tumor biopsies until biopsies have been obtained from 10 subjects (i.e., biopsies are required in at least the first 10 enrolled subjects, or until a goal of 10 study biopsies are obtained). Subjects in whom a biopsy is technically not feasible or in whom would result in unacceptable risk in the opinion of the investigator, may be exempted from the biopsy requirement with discussion with the principal investigator.
- Negative pregnancy test for women of child bearing potential
- Ability to take oral medications
Adequate marrow function:
- Absolute neutrophil count (ANC) ≥1000 /mm3
- Platelet count ≥50,000/mm3
- Hemoglobin ≥8.0g/dL (not requiring transfusion in the past 2 weeks)
- At least 21 days must have elapsed since the last dose of systemic chemotherapy or immunotherapy and the first dose of study drug.
- At least 14 days must have elapsed since the last dose of radiation therapy and the first dose of study drug.
- Patients who have previously been treated with a JAK inhibitor.
- Patients who are receiving any other investigational agents concurrently.
- Patients who have had recent major surgery within a minimum 4 weeks prior to starting study treatment, with the exception of surgical placement for vascular access.
- Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib.
- Patients with symptomatic or growing brain metastases. Patients with brain metastases that have been treated and have remained stable for at least one month prior to initiation of study therapy are eligible.
- Concurrent use of strong CYP3A4 or CYP3A4 substrate drugs with a narrow therapeutic range within 14 days or 5 drug half-lives, whichever is longer, before start of study drug. A list of strong CYP3A4 and 2C8 inhibitors and inducers can be found in Appendix A.
- HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ruxolitinib. In addition, these patients are at increased risk of lethal infections when treated with marrow- suppressive therapy.
- Subjects with known active hepatitis B or C, or chronic hepatitis B or C requiring treatment with antiviral therapy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Patients being actively treated for a second malignancy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04807777
|Contact: Research Nurse Navigatorfirstname.lastname@example.org|
|Contact: Richard Carvajal, MDemail@example.com|
|United States, Georgia|
|Emory University Winship Cancer Institute||Not yet recruiting|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Northwestern University Lurie Cancer Center||Recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Sunandana Chandra, MD, MS 312-695-6182 firstname.lastname@example.org|
|Principal Investigator: Sunandana Chandra, MD, MS|
|United States, New York|
|Columbia University Irving Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Research Nurse Navigator 212-342-5162 email@example.com|
|Contact: Richard Carvajal, MD 646-317-6041 firstname.lastname@example.org|
|Principal Investigator:||Richard Carvajal, MD||Associate Professor of Medicine at the Columbia University Medical Center|
|Responsible Party:||Richard D. Carvajal, Associate Professor of Medicine at the Columbia University Medical Center, Columbia University|
|Other Study ID Numbers:||
|First Posted:||March 19, 2021 Key Record Dates|
|Last Update Posted:||July 1, 2022|
|Last Verified:||June 2022|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Solid Organ Transplant
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell