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)

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT02242045
Collaborator
(none)
6
3
1
36.5
2
0.1

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Subjects With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas or Chronic Lymphocytic Leukemia
Actual Study Start Date :
Oct 1, 2014
Actual Primary Completion Date :
Dec 25, 2014
Actual Study Completion Date :
Oct 17, 2017

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:
  • Zydelig®
  • GS-1101
  • CAL-101
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 8 [Predose and 1.5 hours postdose on Day 8]

    7. Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 15 [Predose and 1.5 hours postdose on Day 15]

    8. Plasma Concentration of Idelalisib and Its Major Metabolite GS-563117 on Day 22 [Predose and 1.5 hours postdose on Day 22]

    9. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02242045
    Other Study ID Numbers:
    • GS-US-313-1380
    First Posted:
    Sep 16, 2014
    Last Update Posted:
    Mar 19, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    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

    1. Primary Outcome
    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%
    2. Primary Outcome
    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%
    3. Primary Outcome
    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%
    4. Primary Outcome
    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%
    5. Primary Outcome
    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)
    6. Primary Outcome
    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)
    7. Primary Outcome
    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)
    8. Primary Outcome
    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)
    9. Primary Outcome
    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)
    10. Secondary Outcome
    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%
    11. Secondary Outcome
    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%
    12. Secondary Outcome
    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%
    13. Secondary Outcome
    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

    [Not Specified]

    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)
    Email GileadClinicalTrials@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT02242045
    Other Study ID Numbers:
    • GS-US-313-1380
    First Posted:
    Sep 16, 2014
    Last Update Posted:
    Mar 19, 2021
    Last Verified:
    Feb 1, 2021