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)
Study Details
Study Description
Brief Summary
The primary objective of this study is to evaluate the 28-day safety and tolerability, and to determine the pharmacokinetics (PK) of idelalisib in Japanese participants with relapsed or refractory indolent B-cell non-Hodgkin lymphomas (iNHL) or chronic lymphocytic leukemia (CLL).
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Idelalisib Participants with iNHL or CLL will receive idelalisib 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. |
Drug: Idelalisib
150 mg tablet(s) administered orally twice daily
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure [First dose date up to 28 days]
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.
- Percentage of Participants Experiencing TEAEs Related to Idelalisib Within 28 Days of Idelalisib Exposure [First dose date up to 28 days]
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.
- Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline [First dose date up to 28 days]
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.
- Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Within 28 Days of Idelalisib Exposure [First dose date up to 28 days]
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.
- Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1]
Lower limit of quantitation was 5 ng/mL for idelalisib and metabolite GS-563117 both.
- Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8 [Predose and 1.5 hours postdose on Day 8]
- Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15 [Predose and 1.5 hours postdose on Day 15]
- Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22 [Predose and 1.5 hours postdose on Day 22]
- Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 [Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 29]
Secondary Outcome Measures
- Percentage of Participants Experiencing TEAEs and SAEs Beyond 28 Days of Idelalisib Exposure [First dose date up to 30 days after last dose (up to approximately 3 years)]
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.
- Percentage of Participants Experiencing TEAEs Related to Idelalisib Beyond 28 Days of Idelalisib Exposure [First dose date up to 30 days after last dose (up to approximately 3 years)]
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.
- Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline [First dose date up to 30 days after last dose (up to approximately 3 years)]
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.
- Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Beyond 28 Days of Idelalisib Exposure [First dose date up to 30 days after last dose (up to approximately 3 years)]
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.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
-
Participants with mature B-cell malignancies of iNHL including follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, and CLL by World Health Organization classification
-
Must have been born in Japan and must not have lived outside of Japan for > 1 year in the 5 years prior to Day 1
-
Must be able to trace maternal and paternal ancestry of parents and grandparents as Japanese
-
Must have been previously treated with at least 1 regimen for iNHL or CLL and currently require treatment
-
Discontinuation of all therapy (including radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of iNHL or CLL ≥ 4 weeks prior to Day 1
-
Eastern Cooperative Oncology Group performance status of 0 or 1
-
Required baseline laboratory data (within 4 weeks prior to Day 1)
-
A negative serum pregnancy test for female participants of childbearing potential
-
Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
-
In the judgment of the investigator, participation in the protocol offers an acceptable benefit-to-risk ratio when considering current disease status, medical condition, and the potential benefits and risks of alternative treatments for the individual's disease.
Key Exclusion Criteria:
-
Known histological transformation to an aggressive histology
-
Known presence of myelodysplastic syndrome
-
History of iNHL or CLL with central nervous system involvement
-
Life expectancy < 120 days as per investigator assessment
-
History of a nonlymphoid malignancy with the following exceptions:
-
the malignancy has been in remission without treatment for ≥ 5 years prior to Day 1, or
-
carcinoma in situ of the cervix, or
-
adequately treated basal or squamous cell skin cancer or other localized nonmelanoma skin cancer, or
-
surgically treated low-grade prostate cancer, or
-
ductal carcinoma in situ of the breast treated with lumpectomy alone
-
On-going drug-induced liver injury, alcoholic liver disease, nonalcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension
-
History or diagnosis of pneumonitis or interstitial lung disease.
-
On-going inflammatory bowel disease
-
Pregnancy or breastfeeding
-
History of prior allogeneic hematopoietic stem cell or solid organ transplantation
-
Concurrent participation in another therapeutic clinical trial
-
Prior or on-going clinically significant illness, medical condition, surgical history, physical finding, electrocardiogram finding, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the individual or impair the assessment of study results.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Aichi | Japan | |||
2 | Miyagi | Japan | |||
3 | Tokyo | Japan |
Sponsors and Collaborators
- Gilead Sciences
Investigators
- Study Director: Gilead Study Director, Gilead Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GS-US-313-1380
Study Results
Participant Flow
Recruitment Details | 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. |
---|---|
Pre-assignment Detail | 6 participants were screened. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Period Title: Overall Study | |
STARTED | 6 |
COMPLETED | 0 |
NOT COMPLETED | 6 |
Baseline Characteristics
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Overall Participants | 6 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
62.3
(10.71)
|
Sex: Female, Male (Count of Participants) | |
Female |
0
0%
|
Male |
6
100%
|
Ethnicity (NIH/OMB) (Count of Participants) | |
Hispanic or Latino |
0
0%
|
Not Hispanic or Latino |
6
100%
|
Unknown or Not Reported |
0
0%
|
Race (NIH/OMB) (Count of Participants) | |
American Indian or Alaska Native |
0
0%
|
Asian |
6
100%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
Black or African American |
0
0%
|
White |
0
0%
|
More than one race |
0
0%
|
Unknown or Not Reported |
0
0%
|
Outcome Measures
Title | Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Within 28 Days of Idelalisib Exposure |
---|---|
Description | 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. |
Time Frame | First dose date up to 28 days |
Outcome Measure Data
Analysis Population Description |
---|
The Full Analysis Set included all participants who took at least 1 dose of study drug. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
TEAEs |
66.7
1111.7%
|
SAEs |
16.7
278.3%
|
Title | Percentage of Participants Experiencing TEAEs Related to Idelalisib Within 28 Days of Idelalisib Exposure |
---|---|
Description | 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. |
Time Frame | First dose date up to 28 days |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
Number [percentage of participants] |
0
0%
|
Title | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Within 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline |
---|---|
Description | 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. |
Time Frame | First dose date up to 28 days |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
Leukocytosis (Grade 1) |
0
0%
|
Leukocytosis (Grade 2) |
0
0%
|
Leukocytosis (Grade 3) |
16.7
278.3%
|
Leukocytosis (Grade 4) |
0
0%
|
White blood cell decreased (Grade 1) |
16.7
278.3%
|
White blood cell decreased (Grade 2) |
0
0%
|
White blood cell decreased (Grade 3) |
16.7
278.3%
|
White blood cell decreased (Grade 4) |
0
0%
|
Neutrophil count decreased (Grade 1) |
16.7
278.3%
|
Neutrophil count decreased (Grade 2) |
16.7
278.3%
|
Neutrophil count decreased (Grade 3) |
0
0%
|
Neutrophil count decreased (Grade 4) |
0
0%
|
Hypocalcemia (Grade 1) |
0
0%
|
Hypocalcemia (Grade 2) |
16.7
278.3%
|
Hypocalcemia (Grade 3) |
0
0%
|
Hypocalcemia (Grade 4) |
0
0%
|
Cholesterol high (Grade 1) |
33.3
555%
|
Cholesterol high (Grade 2) |
0
0%
|
Cholesterol high (Grade 3) |
0
0%
|
Cholesterol high (Grade 4) |
0
0%
|
Creatinine increased (Grade 1) |
16.7
278.3%
|
Creatinine increased (Grade 2) |
0
0%
|
Creatinine increased (Grade 3) |
0
0%
|
Creatinine increased (Grade 4) |
0
0%
|
Chronic Kidney Disease (Grade 1) |
0
0%
|
Chronic Kidney Disease (Grade 2) |
33.3
555%
|
Chronic Kidney Disease (Grade 3) |
0
0%
|
Chronic Kidney Disease (Grade 4) |
0
0%
|
Hypertriglyceridemia (Grade 1) |
33.3
555%
|
Hypertriglyceridemia (Grade 2) |
16.7
278.3%
|
Hypertriglyceridemia (Grade 3) |
0
0%
|
Hypertriglyceridemia (Grade 4) |
0
0%
|
Title | Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Within 28 Days of Idelalisib Exposure |
---|---|
Description | 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. |
Time Frame | First dose date up to 28 days |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
Number [percentage of participants] |
0
0%
|
Title | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 1 |
---|---|
Description | Lower limit of quantitation was 5 ng/mL for idelalisib and metabolite GS-563117 both. |
Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 1 |
Outcome Measure Data
Analysis Population Description |
---|
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. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
Idelalisib: Predose |
NA
(NA)
|
Idelalisib: 0.5 hour |
188.4
(322.97)
|
Idelalisib: 1 hour |
763.9
(1141.85)
|
Idelalisib: 1.5 hour |
1454.0
(1255.23)
|
Idelalisib: 2 hour |
2097.4
(1483.25)
|
Idelalisib: 3 hour |
2226.5
(1231.66)
|
Idelalisib: 4 hour |
2042.3
(1048.57)
|
Idelalisib: 6 hour |
1215.0
(797.50)
|
Idelalisib: 8 hour |
718.5
(532.06)
|
Idelalisib: 12 hour |
291.4
(247.66)
|
GS-563117: Predose |
NA
(NA)
|
GS-563117: 0.5 hour |
6.38
(7.095)
|
GS-563117: 1 hour |
134.92
(153.644)
|
GS-563117: 1.5 hour |
478.75
(507.114)
|
GS-563117: 2 hour |
1005.12
(781.188)
|
GS-563117: 3 hour |
2011.00
(1206.687)
|
GS-563117: 4 hour |
2121.00
(1352.570)
|
GS-563117: 6 hour |
2288.33
(1358.446)
|
GS-563117: 8 hour |
2195.00
(1494.054)
|
GS-563117: 12 hour |
1677.83
(1307.384)
|
Title | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8 |
---|---|
Description | |
Time Frame | Predose and 1.5 hours postdose on Day 8 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the PK Analysis Set were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
Idelalisib: Predose |
463.2
(220.75)
|
Idelalisib: 1.5 hour |
2138.5
(759.23)
|
GS-563117: Predose |
2703.33
(1866.555)
|
GS-563117: 1.5 hour |
3040.00
(1736.237)
|
Title | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15 |
---|---|
Description | |
Time Frame | Predose and 1.5 hours postdose on Day 15 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the PK Analysis Set were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
Idelalisib: Predose |
459.3
(203.64)
|
Idelalisib: 1.5 hour |
2648.3
(1601.70)
|
GS-563117: Predose |
3326.67
(2655.234)
|
GS-563117: 1.5 hour |
3636.67
(2547.883)
|
Title | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22 |
---|---|
Description | |
Time Frame | Predose and 1.5 hours postdose on Day 22 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the PK Analysis Set were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
Idelalisib: Predose |
358.7
(237.86)
|
Idelalisib: 1.5 hour |
2155.0
(782.73)
|
GS-563117: Predose |
2318.33
(1070.111)
|
GS-563117: 1.5 hour |
2828.33
(1749.153)
|
Title | Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 29 |
---|---|
Description | |
Time Frame | Predose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, and 12 hours postdose on Day 29 |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the PK Analysis Set were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
Idelalisib: Predose |
501.2
(329.02)
|
Idelalisib: 0.5 hour |
666.8
(454.58)
|
Idelalisib: 1 hour |
1107.8
(891.69)
|
Idelalisib: 1.5 hour |
1523.3
(990.84)
|
Idelalisib: 2 hour |
1940.0
(1028.47)
|
Idelalisib: 3 hour |
2313.3
(644.13)
|
Idelalisib: 4 hour |
1843.8
(701.36)
|
Idelalisib: 6 hour |
1141.2
(509.70)
|
Idelalisib: 8 hour |
707.2
(340.26)
|
Idelalisib: 12 hour |
403.0
(315.41)
|
GS-563117: Predose Day 29 |
3075.00
(2546.698)
|
GS-563117: 0.5 hour |
2913.33
(2855.182)
|
GS-563117: 1 hour |
2833.33
(2535.387)
|
GS-563117: 1.5 hour |
2930.00
(2585.660)
|
GS-563117: 2 hour |
3185.00
(2799.691)
|
GS-563117: 3 hour |
3781.67
(3058.283)
|
GS-563117: 4 hour |
3893.33
(2996.309)
|
GS-563117: 6 hour |
3653.33
(2900.232)
|
GS-563117: 8 hour |
3428.33
(2987.376)
|
GS-563117: 12 hour |
2871.67
(3309.601)
|
Title | Percentage of Participants Experiencing TEAEs and SAEs Beyond 28 Days of Idelalisib Exposure |
---|---|
Description | 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. |
Time Frame | First dose date up to 30 days after last dose (up to approximately 3 years) |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
TEAEs |
100.0
1666.7%
|
SAEs |
83.3
1388.3%
|
Title | Percentage of Participants Experiencing TEAEs Related to Idelalisib Beyond 28 Days of Idelalisib Exposure |
---|---|
Description | 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. |
Time Frame | First dose date up to 30 days after last dose (up to approximately 3 years) |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
Number [percentage of participants] |
83.3
1388.3%
|
Title | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities Beyond 28 Days of Idelalisib Exposure by Worst Grade at Postbaseline |
---|---|
Description | 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. |
Time Frame | First dose date up to 30 days after last dose (up to approximately 3 years) |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
Anemia (Grade 1) |
0
0%
|
Anemia (Grade 2) |
16.7
278.3%
|
Anemia (Grade 3) |
0
0%
|
Anemia (Grade 4) |
0
0%
|
Leukocytosis (Grade 1) |
0
0%
|
Leukocytosis (Grade 2) |
0
0%
|
Leukocytosis (Grade 3) |
16.7
278.3%
|
Leukocytosis (Grade 4) |
0
0%
|
White blood cell decreased (Grade 1) |
50.0
833.3%
|
White blood cell decreased (Grade 2) |
0
0%
|
White blood cell decreased (Grade 3) |
16.7
278.3%
|
White blood cell decreased (Grade 4) |
0
0%
|
Lymphocyte count decreased (Grade 1) |
0
0%
|
Lymphocyte count decreased (Grade 2) |
16.7
278.3%
|
Lymphocyte count decreased (Grade 3) |
16.7
278.3%
|
Lymphocyte count decreased (Grade 4) |
0
0%
|
Neutrophil count decreased (Grade 1) |
33.3
555%
|
Neutrophil count decreased (Grade 2) |
16.7
278.3%
|
Neutrophil count decreased (Grade 3) |
33.3
555%
|
Neutrophil count decreased (Grade 4) |
0
0%
|
Alanine aminotransferase increased (Grade 1) |
33.3
555%
|
Alanine aminotransferase increased (Grade 2) |
0
0%
|
Alanine aminotransferase increased (Grade 3) |
0
0%
|
Alanine aminotransferase increased (Grade 4) |
16.7
278.3%
|
Hypoalbuminemia (Grade 1) |
0
0%
|
Hypoalbuminemia (Grade 2) |
16.7
278.3%
|
Hypoalbuminemia (Grade 3) |
0
0%
|
Hypoalbuminemia (Grade 4) |
0
0%
|
Hypocalcemia (Grade 1) |
0
0%
|
Hypocalcemia (Grade 2) |
16.7
278.3%
|
Hypocalcemia (Grade 3) |
0
0%
|
Hypocalcemia (Grade 4) |
0
0%
|
Alkaline phosphatase increased (Grade 1) |
16.7
278.3%
|
Alkaline phosphatase increased (Grade 2) |
0
0%
|
Alkaline phosphatase increased (Grade 3) |
0
0%
|
Alkaline phosphatase increased (Grade 4) |
0
0%
|
Aspartate aminotransferase increased (Grade 1) |
33.3
555%
|
Aspartate aminotransferase increased (Grade 2) |
0
0%
|
Aspartate aminotransferase increased (Grade 3) |
16.7
278.3%
|
Aspartate aminotransferase increased (Grade 4) |
0
0%
|
Blood bilirubin increased (Grade 1) |
16.7
278.3%
|
Blood bilirubin increased (Grade 2) |
0
0%
|
Blood bilirubin increased (Grade 3) |
0
0%
|
Blood bilirubin increased (Grade 4) |
0
0%
|
Cholesterol high (Grade 1) |
16.7
278.3%
|
Cholesterol high (Grade 2) |
16.7
278.3%
|
Cholesterol high (Grade 3) |
0
0%
|
Cholesterol high (Grade 4) |
0
0%
|
Creatinine increased (Grade 1) |
50.0
833.3%
|
Creatinine increased (Grade 2) |
16.7
278.3%
|
Creatinine increased (Grade 3) |
0
0%
|
Creatinine increased (Grade 4) |
0
0%
|
Chronic Kidney Disease (Grade 1) |
0
0%
|
Chronic Kidney Disease (Grade 2) |
50.0
833.3%
|
Chronic Kidney Disease (Grade 3) |
16.7
278.3%
|
Chronic Kidney Disease (Grade 4) |
0
0%
|
Gamma Glutamyl Transferase increased (Grade 1) |
50.0
833.3%
|
Gamma Glutamyl Transferase increased (Grade 2) |
16.7
278.3%
|
Gamma Glutamyl Transferase increased (Grade 3) |
0
0%
|
Gamma Glutamyl Transferase increased (Grade 4) |
0
0%
|
Hyperglycemia (Grade 1) |
50.0
833.3%
|
Hyperglycemia (Grade 2) |
0
0%
|
Hyperglycemia (Grade 3) |
16.7
278.3%
|
Hyperglycemia (Grade 4) |
0
0%
|
Hypophosphatemia (Grade 1) |
0
0%
|
Hypophosphatemia (Grade 2) |
16.7
278.3%
|
Hypophosphatemia (Grade 3) |
33.3
555%
|
Hypophosphatemia (Grade 4) |
0
0%
|
Hypokalemia (Grade 1) |
0
0%
|
Hypokalemia (Grade 2) |
0
0%
|
Hypokalemia (Grade 3) |
16.7
278.3%
|
Hypokalemia (Grade 4) |
16.7
278.3%
|
Hyponatremia (Grade 1) |
33.3
555%
|
Hyponatremia (Grade 2) |
0
0%
|
Hyponatremia (Grade 3) |
0
0%
|
Hyponatremia (Grade 4) |
0
0%
|
Hypertriglyceridemia (Grade 1) |
33.3
555%
|
Hypertriglyceridemia (Grade 2) |
0
0%
|
Hypertriglyceridemia (Grade 3) |
33.3
555%
|
Hypertriglyceridemia (Grade 4) |
0
0%
|
Hyperuricemia (Grade 1) |
33.3
555%
|
Hyperuricemia (Grade 2) |
0
0%
|
Hyperuricemia (Grade 3) |
0
0%
|
Hyperuricemia (Grade 4) |
0
0%
|
Title | Percentage of Participants Who Permanently Discontinued Idelalisib Due to a TEAE Beyond 28 Days of Idelalisib Exposure |
---|---|
Description | 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. |
Time Frame | First dose date up to 30 days after last dose (up to approximately 3 years) |
Outcome Measure Data
Analysis Population Description |
---|
Participants in the Full Analysis Set were analyzed. |
Arm/Group Title | Idelalisib |
---|---|
Arm/Group Description | 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. |
Measure Participants | 6 |
Number [percentage of participants] |
16.7
278.3%
|
Adverse Events
Time Frame | First dose date up to approximately 3 years | |
---|---|---|
Adverse Event Reporting Description | The Full Analysis Set included all participants who took at least 1 dose of study drug. | |
Arm/Group Title | Idelalisib | |
Arm/Group Description | 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. | |
All Cause Mortality |
||
Idelalisib | ||
Affected / at Risk (%) | # Events | |
Total | 0/6 (0%) | |
Serious Adverse Events |
||
Idelalisib | ||
Affected / at Risk (%) | # Events | |
Total | 5/6 (83.3%) | |
Gastrointestinal disorders | ||
Diarrhoea | 3/6 (50%) | |
General disorders | ||
Pyrexia | 1/6 (16.7%) | |
Infections and infestations | ||
Infection | 1/6 (16.7%) | |
Pneumonia | 1/6 (16.7%) | |
Investigations | ||
Transaminases increased | 1/6 (16.7%) | |
Metabolism and nutrition disorders | ||
Decreased appetite | 1/6 (16.7%) | |
Other (Not Including Serious) Adverse Events |
||
Idelalisib | ||
Affected / at Risk (%) | # Events | |
Total | 6/6 (100%) | |
Blood and lymphatic system disorders | ||
Anaemia | 1/6 (16.7%) | |
Eye disorders | ||
Optic disc haemorrhage | 1/6 (16.7%) | |
Gastrointestinal disorders | ||
Abdominal discomfort | 1/6 (16.7%) | |
Diarrhoea | 5/6 (83.3%) | |
Gastritis | 3/6 (50%) | |
Gastrointestinal pain | 1/6 (16.7%) | |
Nausea | 2/6 (33.3%) | |
Stomatitis | 1/6 (16.7%) | |
Vomiting | 1/6 (16.7%) | |
General disorders | ||
Chest pain | 1/6 (16.7%) | |
Chills | 1/6 (16.7%) | |
Face oedema | 1/6 (16.7%) | |
Fatigue | 1/6 (16.7%) | |
Malaise | 1/6 (16.7%) | |
Oedema peripheral | 1/6 (16.7%) | |
Pyrexia | 3/6 (50%) | |
Vessel puncture site bruise | 1/6 (16.7%) | |
Vessel puncture site inflammation | 1/6 (16.7%) | |
Infections and infestations | ||
Enteritis infectious | 1/6 (16.7%) | |
Enterocolitis infectious | 1/6 (16.7%) | |
Herpes simplex | 2/6 (33.3%) | |
Infection | 1/6 (16.7%) | |
Oral candidiasis | 1/6 (16.7%) | |
Otitis media | 1/6 (16.7%) | |
Upper respiratory tract infection | 2/6 (33.3%) | |
Investigations | ||
Antithrombin III decreased | 1/6 (16.7%) | |
Blood creatinine increased | 1/6 (16.7%) | |
Gamma-glutamyltransferase increased | 1/6 (16.7%) | |
Neutrophil count decreased | 1/6 (16.7%) | |
Platelet count decreased | 1/6 (16.7%) | |
Transaminases increased | 2/6 (33.3%) | |
Weight decreased | 2/6 (33.3%) | |
Metabolism and nutrition disorders | ||
Decreased appetite | 2/6 (33.3%) | |
Dehydration | 1/6 (16.7%) | |
Hypoalbuminaemia | 1/6 (16.7%) | |
Hypokalaemia | 1/6 (16.7%) | |
Hyponatraemia | 1/6 (16.7%) | |
Hypophosphataemia | 1/6 (16.7%) | |
Musculoskeletal and connective tissue disorders | ||
Back pain | 1/6 (16.7%) | |
Neck pain | 1/6 (16.7%) | |
Nervous system disorders | ||
Dysgeusia | 1/6 (16.7%) | |
Somnolence | 1/6 (16.7%) | |
Psychiatric disorders | ||
Delirium | 1/6 (16.7%) | |
Insomnia | 3/6 (50%) | |
Renal and urinary disorders | ||
Renal failure | 1/6 (16.7%) | |
Respiratory, thoracic and mediastinal disorders | ||
Cough | 1/6 (16.7%) | |
Dyspnoea | 1/6 (16.7%) | |
Hiccups | 1/6 (16.7%) | |
Oropharyngeal pain | 1/6 (16.7%) | |
Pneumonia aspiration | 1/6 (16.7%) | |
Pneumonitis | 1/6 (16.7%) | |
Rhinitis allergic | 1/6 (16.7%) | |
Skin and subcutaneous tissue disorders | ||
Pruritus | 1/6 (16.7%) | |
Rash | 2/6 (33.3%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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
Results Point of Contact
Name/Title | Gilead Clinical Study Information Center |
---|---|
Organization | Gilead Sciences |
Phone | 1-833-445-3230 (GILEAD-0) |
GileadClinicalTrials@gilead.com |
- GS-US-313-1380