Study of Ruxolitinib in Solid Organ Transplant Recipients With Advanced Cutaneous Squamous Cell Carcinoma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04807777|
Recruitment Status : Not yet recruiting
First Posted : March 19, 2021
Last Update Posted : March 19, 2021
|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|
|Estimated Study Start Date :||April 30, 2021|
|Estimated Primary Completion Date :||April 30, 2023|
|Estimated Study Completion Date :||May 31, 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.
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 Navigatoremail@example.com|
|Contact: Richard Carvajal, MDfirstname.lastname@example.org|
|United States, Georgia|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|United States, Illinois|
|Northwestern University Lurie Cancer Center|
|Chicago, Illinois, United States, 60611|
|Contact: Sunandana Chandra, MD, MS 312-695-6182 email@example.com|
|Principal Investigator: Sunandana Chandra, MD, MS|
|United States, New York|
|Columbia University Irving Medical Center|
|New York, New York, United States, 10032|
|Contact: Research Nurse Navigator 212-342-5162 firstname.lastname@example.org|
|Contact: Richard Carvajal, MD 646-317-6041 email@example.com|
|Principal Investigator:||Richard Carvajal, MD||Associate Professor of Medicine at the Columbia University Medical Center|