Trial Outcomes & Findings for Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma (NCT NCT02581930)
NCT ID: NCT02581930
Last Updated: 2025-09-08
Results Overview
Antitumor response defined as the sum of complete response (CR) and partial response (PR). CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
ACTIVE_NOT_RECRUITING
PHASE2
18 participants
1 year
2025-09-08
Participant Flow
Dates of the recruitment period were 12/12/16-12/14/17 in medical clinic.
Participant milestones
| Measure |
Treatment (Ibrutinib)
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacogenomic Study: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Treatment (Ibrutinib)
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacogenomic Study: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
patient declined further treatment
|
1
|
Baseline Characteristics
Ibrutinib in Treating Patients With Refractory Metastatic Cutaneous Melanoma
Baseline characteristics by cohort
| Measure |
Treatment (Ibrutinib)
n=18 Participants
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacogenomic Study: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearAntitumor response defined as the sum of complete response (CR) and partial response (PR). CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=18 Participants
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacogenomic Study: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Number of Subjects With Antitumor Response as Evaluated by Response Evaluation Criteria in Solid Tumors (RECIST) Criteria 1.1
|
0 Participants
|
SECONDARY outcome
Timeframe: 1 yearProgression free survival (PFS) is defined as the duration of time from Day 1 of treatment to time of progression (based on clinical or radiographic grounds) or death as a result of any cause, whichever occurs first.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=18 Participants
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacogenomic Study: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Progression Free Survival
|
1.3 months
Interval 0.2 to 5.5
|
SECONDARY outcome
Timeframe: Duration of time from day 1 of treatment to death as a result of any cause, assessed up to 1 yearEstimated using the Kaplan Meier method.
Outcome measures
| Measure |
Treatment (Ibrutinib)
n=18 Participants
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacogenomic Study: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Overall Survival
|
6 months
Interval 0.3 to 6.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 1 yearAssessed by IHC and 2-color IF and analyzed by Aperio imaging. Exploratory analysis will also be performed to assess the predictive ability of each tissue biomarker by fitting logistic model or Cox model with biomarker as a covariate. Antitumor response rate or PFS information will be used to investigate possible cut-points for the biomarker. Logistic regression analysis will be conducted to assess whether a profile of immune response in tumor biopsies (or in peripheral blood) can be developed that distinguishes patients who respond to treatment versus those who do not.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline up to 1 yearWill be assessed by comparisons using analysis of variance followed by paired t-test or other tests (Wilcoxon rank-sum test), if normality assumption is not satisfied even when data transformation is performed.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Pre-dose on days 1 and day 8 of course 1 and post-dose, 0.5, 1, 2, 4, 6, and 24 hours on day 8 of course 1The following parameters will be estimated: maximum concentration, time of maximum concentration, area under the concentration verses time curve, half-life, apparent clearance, apparent volume of distribution.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Ibrutinib)
Serious adverse events
| Measure |
Treatment (Ibrutinib)
n=18 participants at risk
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacogenomic Study: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Infections and infestations
sepsis
|
5.6%
1/18 • 1 year
|
|
Immune system disorders
cytokine release syncrome
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
constipation
|
5.6%
1/18 • 1 year
|
|
Renal and urinary disorders
hyponatremia
|
22.2%
4/18 • 1 year
|
|
Vascular disorders
hypotension
|
5.6%
1/18 • 1 year
|
|
Vascular disorders
hypertension
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
dehydration
|
5.6%
1/18 • 1 year
|
|
Blood and lymphatic system disorders
decreased lymphocyte count
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
pneumonia
|
5.6%
1/18 • 1 year
|
|
Blood and lymphatic system disorders
anemia
|
5.6%
1/18 • 1 year
|
|
Hepatobiliary disorders
hypoalbuminemia
|
5.6%
1/18 • 1 year
|
Other adverse events
| Measure |
Treatment (Ibrutinib)
n=18 participants at risk
Patients receive ibrutinib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Ibrutinib: Given PO
Laboratory Biomarker Analysis: Correlative studies
Pharmacogenomic Study: Correlative studies
Pharmacological Study: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
anemia
|
38.9%
7/18 • 1 year
|
|
Gastrointestinal disorders
anorexia
|
55.6%
10/18 • 1 year
|
|
General disorders
fatigue
|
55.6%
10/18 • 1 year
|
|
Gastrointestinal disorders
nausea
|
27.8%
5/18 • 1 year
|
|
Gastrointestinal disorders
diarrhea
|
22.2%
4/18 • 1 year
|
|
Blood and lymphatic system disorders
decreased neutrophil count
|
5.6%
1/18 • 1 year
|
|
Blood and lymphatic system disorders
decreased platelet count
|
5.6%
1/18 • 1 year
|
|
Blood and lymphatic system disorders
decreased WBC
|
5.6%
1/18 • 1 year
|
|
Blood and lymphatic system disorders
increased neutrophil count
|
5.6%
1/18 • 1 year
|
|
Blood and lymphatic system disorders
increased WBC count
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
vomiting
|
22.2%
4/18 • 1 year
|
|
Hepatobiliary disorders
hypoalbuminemia
|
16.7%
3/18 • 1 year
|
|
Metabolism and nutrition disorders
hypomagnesemia
|
11.1%
2/18 • 1 year
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
hyponatremia
|
5.6%
1/18 • 1 year
|
|
Cardiac disorders
hypertension
|
11.1%
2/18 • 1 year
|
|
Cardiac disorders
palpitations
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
constipation
|
5.6%
1/18 • 1 year
|
|
Nervous system disorders
headaches
|
11.1%
2/18 • 1 year
|
|
General disorders
fever
|
16.7%
3/18 • 1 year
|
|
General disorders
chills
|
11.1%
2/18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
22.2%
4/18 • 1 year
|
|
Gastrointestinal disorders
oral mucositis
|
11.1%
2/18 • 1 year
|
|
Metabolism and nutrition disorders
hypokalemia
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
hypocalcemia
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
dysgeusia
|
11.1%
2/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
rash
|
22.2%
4/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
bruising
|
11.1%
2/18 • 1 year
|
|
Nervous system disorders
diziness
|
11.1%
2/18 • 1 year
|
|
Metabolism and nutrition disorders
dehydration
|
5.6%
1/18 • 1 year
|
|
Renal and urinary disorders
hematuria
|
5.6%
1/18 • 1 year
|
|
Renal and urinary disorders
proteinuria
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
limb edema
|
11.1%
2/18 • 1 year
|
|
Eye disorders
blurry vision
|
5.6%
1/18 • 1 year
|
|
Eye disorders
eye redness
|
5.6%
1/18 • 1 year
|
|
Nervous system disorders
anxiety
|
5.6%
1/18 • 1 year
|
|
General disorders
lethargy
|
5.6%
1/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
flushing
|
5.6%
1/18 • 1 year
|
|
Skin and subcutaneous tissue disorders
pruritus
|
5.6%
1/18 • 1 year
|
|
Cardiac disorders
sinus tachycardia
|
5.6%
1/18 • 1 year
|
|
Metabolism and nutrition disorders
AlPhos increased
|
5.6%
1/18 • 1 year
|
|
Hepatobiliary disorders
Bilirubin increased
|
5.6%
1/18 • 1 year
|
|
Nervous system disorders
tremor
|
11.1%
2/18 • 1 year
|
|
Nervous system disorders
insomnia
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
dysphagia
|
5.6%
1/18 • 1 year
|
|
Gastrointestinal disorders
hiccups
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
restless legs
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
joint effusion
|
5.6%
1/18 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
hoarseness
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
tooth infection
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
urinary tract infection
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
facial edema
|
5.6%
1/18 • 1 year
|
|
Musculoskeletal and connective tissue disorders
trunk edema
|
5.6%
1/18 • 1 year
|
|
General disorders
pain
|
11.1%
2/18 • 1 year
|
|
General disorders
abdominal pain
|
5.6%
1/18 • 1 year
|
|
General disorders
flank pain
|
5.6%
1/18 • 1 year
|
|
Infections and infestations
sinusitis
|
5.6%
1/18 • 1 year
|
Additional Information
Dr. Stergios Moschos
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60