Trial Outcomes & Findings for Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL) (NCT NCT02242045)
NCT ID: NCT02242045
Last Updated: 2021-03-19
Results Overview
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
First dose date up to 28 days
Results posted on
2021-03-19
Participant Flow
Participants were enrolled at study sites in Japan. The first participant was screened on 01 October 2014. The last study visit occurred on 17 October 2017.
6 participants were screened.
Participant milestones
| Measure |
Idelalisib
Participants with indolent non-hodgkin lymphoma (iNHL) or chronic lymphocytic leukemia (CLL) received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Idelalisib
Participants with indolent non-hodgkin lymphoma (iNHL) or chronic lymphocytic leukemia (CLL) received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Overall Study
Investigator's Discretion
|
1
|
|
Overall Study
Progressive Disease
|
2
|
|
Overall Study
Unable to tolerate rechallenge with idelalisib
|
1
|
|
Overall Study
Initiated another anti-cancer or experimental therapy
|
2
|
Baseline Characteristics
Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL)
Baseline characteristics by cohort
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 10.71 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 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
|
6 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: First dose date up to 28 daysPopulation: The Full Analysis Set included all participants who took at least 1 dose of study drug.
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure
TEAEs
|
66.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure
SAEs
|
16.7 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to 28 daysPopulation: Participants in the Full Analysis Set were analyzed.
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Percentage of Participants Experiencing TEAEs Related to Idelalisib Within 28 Days of Idelalisib Exposure
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to 28 daysPopulation: Participants in the Full Analysis Set were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. If the relevant baseline laboratory value was missing, then any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment-emergent.The most severe graded abnormality from all tests was counted for each participant. Treatment-emergent laboratory abnormalities were graded per Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Leukocytosis (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Cholesterol high (Grade 1)
|
33.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Chronic Kidney Disease (Grade 1)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypertriglyceridemia (Grade 1)
|
33.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypertriglyceridemia (Grade 2)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypertriglyceridemia (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Leukocytosis (Grade 1)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Leukocytosis (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Leukocytosis (Grade 3)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 1)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 3)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 1)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 2)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 1)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 2)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Cholesterol high (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Cholesterol high (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Cholesterol high (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 1)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Chronic Kidney Disease (Grade 2)
|
33.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Chronic Kidney Disease (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Chronic Kidney Disease (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypertriglyceridemia (Grade 4)
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to 28 daysPopulation: Participants in the Full Analysis Set were analyzed.
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Within 28 Days of Idelalisib Exposure
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1Population: The Pharmacokinetic (PK) Analysis Set included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose value reported by the PK laboratory.
Lower limit of quantitation was 5 ng/mL for idelalisib and metabolite GS-563117 both.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
GS-563117: 0.5 hour
|
6.38 ng/mL
Standard Deviation 7.095
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
GS-563117: 1 hour
|
134.92 ng/mL
Standard Deviation 153.644
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
GS-563117: 1.5 hour
|
478.75 ng/mL
Standard Deviation 507.114
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
GS-563117: 2 hour
|
1005.12 ng/mL
Standard Deviation 781.188
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
Idelalisib: Predose
|
NA ng/mL
Standard Deviation NA
Values were all below the limit of quantitation.
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
Idelalisib: 0.5 hour
|
188.4 ng/mL
Standard Deviation 322.97
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
Idelalisib: 1 hour
|
763.9 ng/mL
Standard Deviation 1141.85
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
Idelalisib: 1.5 hour
|
1454.0 ng/mL
Standard Deviation 1255.23
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
Idelalisib: 2 hour
|
2097.4 ng/mL
Standard Deviation 1483.25
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
Idelalisib: 3 hour
|
2226.5 ng/mL
Standard Deviation 1231.66
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
Idelalisib: 4 hour
|
2042.3 ng/mL
Standard Deviation 1048.57
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
Idelalisib: 6 hour
|
1215.0 ng/mL
Standard Deviation 797.50
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
Idelalisib: 8 hour
|
718.5 ng/mL
Standard Deviation 532.06
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
Idelalisib: 12 hour
|
291.4 ng/mL
Standard Deviation 247.66
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
GS-563117: Predose
|
NA ng/mL
Standard Deviation NA
Values were all below the limit of quantitation.
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
GS-563117: 3 hour
|
2011.00 ng/mL
Standard Deviation 1206.687
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
GS-563117: 4 hour
|
2121.00 ng/mL
Standard Deviation 1352.570
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
GS-563117: 6 hour
|
2288.33 ng/mL
Standard Deviation 1358.446
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
GS-563117: 8 hour
|
2195.00 ng/mL
Standard Deviation 1494.054
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1
GS-563117: 12 hour
|
1677.83 ng/mL
Standard Deviation 1307.384
|
PRIMARY outcome
Timeframe: Predose and 1.5 hours postdose on Day 8Population: Participants in the PK Analysis Set were analyzed.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8
GS-563117: 1.5 hour
|
3040.00 ng/mL
Standard Deviation 1736.237
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8
Idelalisib: Predose
|
463.2 ng/mL
Standard Deviation 220.75
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8
Idelalisib: 1.5 hour
|
2138.5 ng/mL
Standard Deviation 759.23
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8
GS-563117: Predose
|
2703.33 ng/mL
Standard Deviation 1866.555
|
PRIMARY outcome
Timeframe: Predose and 1.5 hours postdose on Day 15Population: Participants in the PK Analysis Set were analyzed.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15
Idelalisib: Predose
|
459.3 ng/mL
Standard Deviation 203.64
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15
Idelalisib: 1.5 hour
|
2648.3 ng/mL
Standard Deviation 1601.70
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15
GS-563117: Predose
|
3326.67 ng/mL
Standard Deviation 2655.234
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15
GS-563117: 1.5 hour
|
3636.67 ng/mL
Standard Deviation 2547.883
|
PRIMARY outcome
Timeframe: Predose and 1.5 hours postdose on Day 22Population: Participants in the PK Analysis Set were analyzed.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22
Idelalisib: Predose
|
358.7 ng/mL
Standard Deviation 237.86
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22
Idelalisib: 1.5 hour
|
2155.0 ng/mL
Standard Deviation 782.73
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22
GS-563117: Predose
|
2318.33 ng/mL
Standard Deviation 1070.111
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22
GS-563117: 1.5 hour
|
2828.33 ng/mL
Standard Deviation 1749.153
|
PRIMARY outcome
Timeframe: Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 29Population: Participants in the PK Analysis Set were analyzed.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
Idelalisib: 4 hour
|
1843.8 ng/mL
Standard Deviation 701.36
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
Idelalisib: 6 hour
|
1141.2 ng/mL
Standard Deviation 509.70
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
Idelalisib: 8 hour
|
707.2 ng/mL
Standard Deviation 340.26
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
Idelalisib: 12 hour
|
403.0 ng/mL
Standard Deviation 315.41
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
GS-563117: Predose Day 29
|
3075.00 ng/mL
Standard Deviation 2546.698
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
GS-563117: 0.5 hour
|
2913.33 ng/mL
Standard Deviation 2855.182
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
Idelalisib: Predose
|
501.2 ng/mL
Standard Deviation 329.02
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
Idelalisib: 0.5 hour
|
666.8 ng/mL
Standard Deviation 454.58
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
Idelalisib: 1 hour
|
1107.8 ng/mL
Standard Deviation 891.69
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
Idelalisib: 1.5 hour
|
1523.3 ng/mL
Standard Deviation 990.84
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
Idelalisib: 2 hour
|
1940.0 ng/mL
Standard Deviation 1028.47
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
Idelalisib: 3 hour
|
2313.3 ng/mL
Standard Deviation 644.13
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
GS-563117: 1 hour
|
2833.33 ng/mL
Standard Deviation 2535.387
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
GS-563117: 1.5 hour
|
2930.00 ng/mL
Standard Deviation 2585.660
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
GS-563117: 2 hour
|
3185.00 ng/mL
Standard Deviation 2799.691
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
GS-563117: 3 hour
|
3781.67 ng/mL
Standard Deviation 3058.283
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
GS-563117: 4 hour
|
3893.33 ng/mL
Standard Deviation 2996.309
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
GS-563117: 6 hour
|
3653.33 ng/mL
Standard Deviation 2900.232
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
GS-563117: 8 hour
|
3428.33 ng/mL
Standard Deviation 2987.376
|
|
Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29
GS-563117: 12 hour
|
2871.67 ng/mL
Standard Deviation 3309.601
|
SECONDARY outcome
Timeframe: First dose date up to 30 days after last dose (up to approximately 3 years)Population: Participants in the Full Analysis Set were analyzed.
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Percentage of Participants Experiencing TEAEs and SAEs Beyond 28 Days of Idelalisib Exposure
TEAEs
|
100.0 percentage of participants
|
|
Percentage of Participants Experiencing TEAEs and SAEs Beyond 28 Days of Idelalisib Exposure
SAEs
|
83.3 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to 30 days after last dose (up to approximately 3 years)Population: Participants in the Full Analysis Set were analyzed.
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Percentage of Participants Experiencing TEAEs Related to Idelalisib Beyond 28 Days of Idelalisib Exposure
|
83.3 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to 30 days after last dose (up to approximately 3 years)Population: Participants in the Full Analysis Set were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant. Treatment-emergent laboratory abnormalities were graded per CTCAE, Version 4.03 where 1=Mild, 2=Moderate, 3=Severe, 4=Potentially Life Threatening.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Anemia (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Leukocytosis (Grade 3)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count decreased (Grade 1)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 2)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alkaline phosphatase increased (Grade 1)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alkaline phosphatase increased (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Aspartate aminotransferase increased (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Cholesterol high (Grade 2)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 2)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Chronic Kidney Disease (Grade 3)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Chronic Kidney Disease (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperglycemia (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypophosphatemia (Grade 2)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypokalemia (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypokalemia (Grade 3)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Cholesterol high (Grade 1)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Cholesterol high (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Cholesterol high (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 1)
|
50.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Anemia (Grade 1)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Anemia (Grade 2)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Anemia (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Leukocytosis (Grade 1)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Leukocytosis (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Leukocytosis (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 1)
|
50.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 3)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
White blood cell decreased (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count decreased (Grade 2)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count decreased (Grade 3)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Lymphocyte count decreased (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 1)
|
33.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 2)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 3)
|
33.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Neutrophil count decreased (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alanine aminotransferase increased (Grade 1)
|
33.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alanine aminotransferase increased (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alanine aminotransferase increased (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alanine aminotransferase increased (Grade 4)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypoalbuminemia (Grade 1)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypoalbuminemia (Grade 2)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypoalbuminemia (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypoalbuminemia (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypocalcemia (Grade 1)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alkaline phosphatase increased (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Alkaline phosphatase increased (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Aspartate aminotransferase increased (Grade 1)
|
33.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Aspartate aminotransferase increased (Grade 3)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Aspartate aminotransferase increased (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Blood bilirubin increased (Grade 1)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Blood bilirubin increased (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Blood bilirubin increased (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Blood bilirubin increased (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Creatinine increased (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Chronic Kidney Disease (Grade 1)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Chronic Kidney Disease (Grade 2)
|
50.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Gamma Glutamyl Transferase increased (Grade 1)
|
50.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Gamma Glutamyl Transferase increased (Grade 2)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Gamma Glutamyl Transferase increased (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Gamma Glutamyl Transferase increased (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperglycemia (Grade 1)
|
50.0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperglycemia (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperglycemia (Grade 3)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypophosphatemia (Grade 1)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypophosphatemia (Grade 3)
|
33.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypophosphatemia (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypokalemia (Grade 1)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypokalemia (Grade 4)
|
16.7 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyponatremia (Grade 1)
|
33.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyponatremia (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyponatremia (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyponatremia (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypertriglyceridemia (Grade 1)
|
33.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypertriglyceridemia (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypertriglyceridemia (Grade 3)
|
33.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hypertriglyceridemia (Grade 4)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperuricemia (Grade 1)
|
33.3 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperuricemia (Grade 2)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperuricemia (Grade 3)
|
0 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline
Hyperuricemia (Grade 4)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: First dose date up to 30 days after last dose (up to approximately 3 years)Population: Participants in the Full Analysis Set were analyzed.
An AE was any untoward medical occurrence in a clinical study participant which did not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and/or unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. TEAEs were defined as 1 or both of the following: 1) Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug; and/or 2) Any AEs leading to premature discontinuation of study drug.
Outcome measures
| Measure |
Idelalisib
n=6 Participants
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Beyond 28 Days of Idelalisib Exposure
|
16.7 percentage of participants
|
Adverse Events
Idelalisib
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Idelalisib
n=6 participants at risk
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Infection
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Transaminases increased
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
Other adverse events
| Measure |
Idelalisib
n=6 participants at risk
Participants with iNHL or CLL received idelalisib 150 mg tablet orally twice daily until the earliest of the following: unacceptable toxicity, substantial noncompliance, disease progression, pregnancy, initiation of another anticancer or experimental therapy, investigator discretion, or idelalisib discontinuation.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Eye disorders
Optic disc haemorrhage
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
83.3%
5/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
50.0%
3/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
2/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Chest pain
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Chills
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Face oedema
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Malaise
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
50.0%
3/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Vessel puncture site bruise
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
General disorders
Vessel puncture site inflammation
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Enteritis infectious
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Enterocolitis infectious
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Herpes simplex
|
33.3%
2/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Infection
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Otitis media
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
2/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Antithrombin III decreased
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Transaminases increased
|
33.3%
2/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Investigations
Weight decreased
|
33.3%
2/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
2/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Nervous system disorders
Somnolence
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Delirium
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
50.0%
3/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • First dose date up to approximately 3 years
The Full Analysis Set included all participants who took at least 1 dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER