Trial Outcomes & Findings for Ruxolitinib in Operable Head and Neck Cancer (NCT NCT03153982)
NCT ID: NCT03153982
Last Updated: 2024-10-30
Results Overview
Measured clinical ruxolitinib response of quantitative change in tumor size measured as a proportional percent (range -100% to +100%) from baseline to day 14-21 by group.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
Up to 4 weeks
Results posted on
2024-10-30
Participant Flow
Participant milestones
| Measure |
Neoadjuvant Ruxolitinib
Participants will take 15 mg or 20 mg of ruxolitinib by mouth twice daily for up to 4 weeks during the pre-operative window for 14-21 days, or up to 28 days for delays in planned surgery. Dose will be assigned based on participant platelet count at baseline. The last dose will be taken the morning of planned surgery. Ruxolitinib will be dispensed in 5 mg tablets. Participants will either take three tables (15 mg) in the morning and evening, or four tablets in the morning and evening (20 mg). Participants will be asked to fill out a drug diary indicating when doses of study drug are taken and any side effects they experience.
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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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16
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ruxolitinib in Operable Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Neoadjuvant Ruxolitinib
n=16 Participants
Participants will take 15 mg or 20 mg of ruxolitinib by mouth twice daily for up to 4 weeks during the pre-operative window for 14-21 days, or up to 28 days for delays in planned surgery. Dose will be assigned based on participant platelet count at baseline. The last dose will be taken the morning of planned surgery. Ruxolitinib will be dispensed in 5 mg tablets. Participants will either take three tables (15 mg) in the morning and evening, or four tablets in the morning and evening (20 mg). Participants will be asked to fill out a drug diary indicating when doses of study drug are taken and any side effects they experience.
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|---|---|
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Age, Customized
40-49 years old
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1 Participants
n=5 Participants
|
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Age, Customized
50-59 years old
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6 Participants
n=5 Participants
|
|
Age, Customized
60-69 years old
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3 Participants
n=5 Participants
|
|
Age, Customized
70-79 years old
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5 Participants
n=5 Participants
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Age, Customized
80-89 years old
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1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
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8 Participants
n=5 Participants
|
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Sex: Female, Male
Male
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8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
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14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
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2 Participants
n=5 Participants
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|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
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Region of Enrollment
United States
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16 participants
n=5 Participants
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PRIMARY outcome
Timeframe: Up to 4 weeksPopulation: Data not collected
Measured clinical ruxolitinib response of quantitative change in tumor size measured as a proportional percent (range -100% to +100%) from baseline to day 14-21 by group.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksThe number of participants with treatment-related adverse events, defined as definite, probable or possibly related to the study intervention and classified according to NCI CTCAE version 4 will be reported.
Outcome measures
| Measure |
Neoadjuvant Ruxolitinib
n=16 Participants
Participants will take 15 mg or 20 mg of ruxolitinib by mouth twice daily for up to 4 weeks during the pre-operative window for 14-21 days, or up to 28 days for delays in planned surgery. Dose will be assigned based on participant platelet count at baseline. The last dose will be taken the morning of planned surgery. Ruxolitinib will be dispensed in 5 mg tablets. Participants will either take three tables (15 mg) in the morning and evening, or four tablets in the morning and evening (20 mg). Participants will be asked to fill out a drug diary indicating when doses of study drug are taken and any side effects they experience.
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|---|---|
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Number of Participants With Treatment-related Adverse Events
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1 Participants
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SECONDARY outcome
Timeframe: Up to 12 weeks.The number of participants with documented surgical complications will be reported.
Outcome measures
| Measure |
Neoadjuvant Ruxolitinib
n=16 Participants
Participants will take 15 mg or 20 mg of ruxolitinib by mouth twice daily for up to 4 weeks during the pre-operative window for 14-21 days, or up to 28 days for delays in planned surgery. Dose will be assigned based on participant platelet count at baseline. The last dose will be taken the morning of planned surgery. Ruxolitinib will be dispensed in 5 mg tablets. Participants will either take three tables (15 mg) in the morning and evening, or four tablets in the morning and evening (20 mg). Participants will be asked to fill out a drug diary indicating when doses of study drug are taken and any side effects they experience.
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|---|---|
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Number of Participants With Documented Surgical Complications
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0 Participants
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SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Hospital stay length data not collected
The median length of hospital stay following the standard of care, surgical procedure will be reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 12 weeksPopulation: Ki-67 proliferative index data not collected
A high Ki-67 proliferation index means many cells are dividing quickly and that the cancer is likely to grow and spread. A Ki-67 proliferation index over 30% is typically considered high. The Ki-67 proliferative index will be measured at baseline and post-treatment tumor tissue.
Outcome measures
Outcome data not reported
Adverse Events
Neoadjuvant Ruxolitinib
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Neoadjuvant Ruxolitinib
n=16 participants at risk
Participants will take 15 mg or 20 mg of ruxolitinib by mouth twice daily for up to 4 weeks during the pre-operative window for 14-21 days, or up to 28 days for delays in planned surgery. Dose will be assigned based on participant platelet count at baseline. The last dose will be taken the morning of planned surgery. Ruxolitinib will be dispensed in 5 mg tablets. Participants will either take three tables (15 mg) in the morning and evening, or four tablets in the morning and evening (20 mg). Participants will be asked to fill out a drug diary indicating when doses of study drug are taken and any side effects they experience.
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|---|---|
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Infections and infestations
Skin infection
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
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Infections and infestations
Urinary tract infection
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
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Musculoskeletal and connective tissue disorders
Trismus
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
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Other adverse events
| Measure |
Neoadjuvant Ruxolitinib
n=16 participants at risk
Participants will take 15 mg or 20 mg of ruxolitinib by mouth twice daily for up to 4 weeks during the pre-operative window for 14-21 days, or up to 28 days for delays in planned surgery. Dose will be assigned based on participant platelet count at baseline. The last dose will be taken the morning of planned surgery. Ruxolitinib will be dispensed in 5 mg tablets. Participants will either take three tables (15 mg) in the morning and evening, or four tablets in the morning and evening (20 mg). Participants will be asked to fill out a drug diary indicating when doses of study drug are taken and any side effects they experience.
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|---|---|
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Gastrointestinal disorders
Oral hemorrhage
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12.5%
2/16 • Number of events 2 • Up to 12 weeks
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General disorders
Fatigue
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
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General disorders
General disorders and administration site conditions - Other
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
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Infections and infestations
Non-cardiac chest pain
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
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Infections and infestations
Kidney infection
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
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Investigations
Aspartate aminotransferase increased
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
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Investigations
Weight Loss
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
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Musculoskeletal and connective tissue disorders
Back pain
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
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Investigations
Pain in extremity
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
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Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
|
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Cardiac disorders
Atrial fibrillation
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
|
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Nervous system disorders
Dysarthria
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
|
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Respiratory, thoracic and mediastinal disorders
Cough
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
|
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Respiratory, thoracic and mediastinal disorders
Sleep apnea
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
|
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Vascular disorders
Hypertension
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
|
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Skin and subcutaneous tissue disorders
Tissue sloughing off tumor
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6.2%
1/16 • Number of events 1 • Up to 12 weeks
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Additional Information
WIlliam Ryan, MD
University of California, San Francisco
Phone: (415) 502-1877
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place