Trial Outcomes & Findings for A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL) (NCT NCT02801578)
NCT ID: NCT02801578
Last Updated: 2020-02-27
Results Overview
BTK occupancy level measured by fluorescent affinity probe just before dosing and at 4 and 24 hours post-dosing on days 1, 8, and 28 (but before the first dose of the next cycle) of each cycle.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
11 participants
Primary outcome timeframe
3 cycles, up to 90 days
Results posted on
2020-02-27
Participant Flow
Recruitment Period: July 2016 to June 2017
Participant milestones
| Measure |
Ibrutinib
Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.
During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.
Ibrutinib: Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule).
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Ibrutinib
Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.
During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.
Ibrutinib: Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule).
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|---|---|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)
Baseline characteristics by cohort
| Measure |
Ibrutinib
n=11 Participants
Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.
During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.
Ibrutinib: Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=99 Participants
|
|
Age, Continuous
|
68 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 cycles, up to 90 daysBTK occupancy level measured by fluorescent affinity probe just before dosing and at 4 and 24 hours post-dosing on days 1, 8, and 28 (but before the first dose of the next cycle) of each cycle.
Outcome measures
| Measure |
Ibrutinib
n=9 Participants
Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.
During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.
Ibrutinib: Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule).
|
|---|---|
|
Participants With >/= 95 % Bruton's Tyrosine Kinase (BTK) Occupancy
|
8 Participants
|
Adverse Events
Ibrutinib
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ibrutinib
n=11 participants at risk
Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.
During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.
Ibrutinib: Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule).
|
|---|---|
|
Surgical and medical procedures
Surgical Procedure
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
Other adverse events
| Measure |
Ibrutinib
n=11 participants at risk
Participants take Ibrutinib capsules by mouth every day for 3, 28 day cycles.
During Cycle 1, participants receive the highest dose of Ibrutinib by taking 3 capsules each day. During Cycle 2, participants receive the second-highest dose and will take 2 capsules each day. During Cycle 3, participant takes the lowest dose of Ibrutinib and takes 1 capsule each day.
Ibrutinib: Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule).
|
|---|---|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • Number of events 2 • Up to 2 years
|
|
Gastrointestinal disorders
Diarrhea
|
27.3%
3/11 • Number of events 3 • Up to 2 years
|
|
Injury, poisoning and procedural complications
Bruising
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Rash Acneiform
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Number of events 1 • Up to 2 years
|
Additional Information
Prithviraj Bose, MD./Associate Professor
The University of Texas MD Anderson Cancer Center
Phone: 713-792-7747
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place