Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma

Sponsor
Gilead Sciences (Industry)
Overall Status
Completed
CT.gov ID
NCT01393106
Collaborator
(none)
25
3
1
35
8.3
0.2

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy and safety of idelalisib in participants with relapsed of refractory Hodgkin Lymphoma (HL). The primary objective will be to assess the overall response rate.

Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg twice daily. Treatment with idelalisib will continue until tumor progression or unacceptable toxicity.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study to Assess the Efficacy and Safety of GS-1101 (CAL-101) in Patients With Relapsed or Refractory Hodgkin Lymphoma
Study Start Date :
Sep 1, 2011
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Idelalisib

Participants will receive up to 300 mg of idelalisib twice daily.

Drug: Idelalisib
Idelalisib tablets administered orally
Other Names:
  • Zydelig®
  • GS-1101
  • CAL-101
  • Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate [Up to Week 110]

      Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions.

    Secondary Outcome Measures

    1. Duration of Response [Up to Week 110]

      Duration of response (DOR) was defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression or death from any cause.

    2. Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of Target Lymph Nodes as Documented Radiographically [Baseline, Week 8, Week 48, and up to Week 110]

    3. Change From Baseline in Fluorodeoxyglucose (FDG) Uptake in Lymph Nodes as Assessed by Positron-emission Tomography (PET) [Up to Week 110]

    4. Time to Response [Up to Week 110]

      Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR.

    5. Overall Survival [Up to Week 110]

      Overall survival was defined as the time from start of idelalisib treatment to death from any cause.

    6. Progression Free Survival [Up to Week 110]

      Progression free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.

    7. Time to Treatment Failure [Up to Week 110]

      Time to treatment failure (TTF) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression, the permanent cessation of idelalisib therapy due to an adverse event, or death from any cause.

    8. Changes in Health-related Quality of Life as Reported Using the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) Questionnaire [Baseline and up to Week 110]

      Change in health-related quality of life was reported by participants using the FACT-Lym questionnaire assessment tool. Results are presented as the mean (SD) best change from baseline in FACT-Lym total score, which was defined as the highest change score (improvement) after baseline. The FACT-Lym total score is on a scale from 0-168, with higher scores associated with a better quality of life.

    9. Changes in Performance Status as Documented Using the Karnofsky Performance Criteria for Participants ≥ 16 Years of Age and the Lansky Performance Criteria for Participants < 16 Years of Age [Baseline and up to Week 110]

      Changes in performance status were assessed using the Karnofsky performance criteria for participants ≥ 16 years of age and the Lansky performance criteria for participants < 16 years of age. Since there were no participants < 16 years of age, only the Karnofsky performance criteria were used. The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classifies patients according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.

    10. Changes in the Plasma Concentrations of Disease-associated Chemokines and Cytokines [Up to Week 110]

    11. Overall Safety Profile of Idelalisib [Up to Week 110]

      The overall safety of idelalisib was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib), clinically significant abnormal electrocardiograms (ECG), and laboratory abnormalities. "Clinically significant" abnormalities in ECG were as determined by the investigator.

    12. Compliance With Study Drug Dosing as Assessed by Accounting for Used and Unused Drug [Up to Week 110]

    13. Idelalisib Trough and Peak Plasma Concentration at Week 4 [Predose and 1.5 hours postdose at Week 4]

      Plasma samples were collected predose (trough) and 1.5 hours postdose (peak). The minimum and maximum value among participants sampled at each time point are presented. Results of less than the lower limit of quantitation (ie, 5 ng/mL) were treated as zero prior to the achievement of the first quantifiable concentration and as missing otherwise.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age ≥ 12 years

    • Karnofsky performance score of ≥ 60 (Eastern Cooperative Oncology Group (ECOG) performance score of 0, 1, or 2)

    • Histologically confirmed diagnosis of classic HL (ie, nodular sclerosis, mixed cellularity, lymphocyte depleted, and or lymphocyte rich types)

    • Nodal HL that shows fluorodeoxyglucose (FDG) avidity (defined as focal or diffuse FDG uptake above background in a location incompatible with normal anatomy or physiology), and is measurable (defined as the presence of ≥ 1 nodal lesion that measures ≥ 2 cm in a single dimension as assessed by CT, PET/CT, or magnetic resonance imaging (MRI))

    • Relapsed or refractory HL after prior myeloablative therapy with autologous stem cell transplantation (ASCT) or after ≥ 2 prior chemotherapy-containing regimens and no curative option with conventional therapy

    • Discontinuation of all radiotherapy or chemotherapy for the treatment of HL greater than or equal to 3 weeks before initiation of study treatment and discontinuation of all radioimmunotherapy for HL (Visit 2)

    • All acute toxic effects (excluding alopecia, neurotoxicity, or anemia) of any prior antitumor therapy resolved to Grade ≤ 2 before initiation of study treatment (Visit 2)

    • For men and women of childbearing potential willingness to abstain from sexual intercourse or employ an effective method of contraception during the study drug administration and follow-up periods

    • Willingness and ability to provide written informed consent and to comply with protocol requirements

    Exclusion Criteria:
    • Known active central nervous system or leptomeningeal lymphoma

    • History of a non-lymphoma malignancy except for the following: adequately treated local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, superficial bladder cancer, localized prostate cancer, other adequately treated Stage 1 or 2 cancer currently in complete remission, or any other cancer that has been in complete remission for ≥ 5 years

    • Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral upper respiratory tract infections) at the time of initiation of study treatment (Visit 2)

    • Pregnancy or breastfeeding

    • Ongoing alcohol or drug addiction

    • Known history of drug-induced liver injury, chronic active hepatitis C virus (HCV), chronic active hepatitis B virus (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver or portal hypertension

    • History of prior allogeneic bone marrow progenitor cell or solid organ transplantation

    • Ongoing immunosuppressive therapy, including systemic corticosteroids.

    • Prior therapy with idelalisib

    • Exposure to another investigational drug within 3 weeks prior to start of study treatment

    • Concurrent participation in another therapeutic treatment trial

    • Prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, ECG finding, or laboratory abnormality that, in the investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism or excretion of the study drug; or impair the assessment of study results

    • Prior therapy with any drug that inhibits Akt, Bruton tyrosine kinase (BTK), Janus kinase (JAK), mammalian target of rapamycin (mTOR), phosphatidylinositol 3 kinase (PI3K) (including idelalisib), or spleen tyrosine kinase (SYK)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan Kettering Cancer Center New York New York United States 10065
    2 MD Anderson Cancer Center Houston Texas United States 77030
    3 Fred Hutchinson Cancer Research Center Seattle Washington United States 98109

    Sponsors and Collaborators

    • Gilead Sciences

    Investigators

    • Study Director: Lyndah Dreiling, MD, Gilead Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01393106
    Other Study ID Numbers:
    • 101-11
    First Posted:
    Jul 13, 2011
    Last Update Posted:
    Nov 19, 2018
    Last Verified:
    Nov 1, 2015
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Gilead Sciences
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details Participants were enrolled at study sites in the United States. The first participant was screened on 15 September 2011. The last study visit occurred on 28 August 2014.
    Pre-assignment Detail 32 participants were screened.
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Period Title: Overall Study
    STARTED 25
    COMPLETED 20
    NOT COMPLETED 5

    Baseline Characteristics

    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Overall Participants 25
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    43
    (16.1)
    Sex: Female, Male (Count of Participants)
    Female
    14
    56%
    Male
    11
    44%
    Race/Ethnicity, Customized (participants) [Number]
    Asian
    1
    4%
    Black or African American
    2
    8%
    White
    19
    76%
    Other
    3
    12%
    Race/Ethnicity, Customized (participants) [Number]
    Hispanic or Latino
    3
    12%
    Not Hispanic or Latino
    22
    88%
    Time Since Diagnosis (years) (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    3.9
    (4.26)
    Classical Hodgkin Lymphoma Pathologic Subtype (participants) [Number]
    Nodular Sclerosis
    23
    92%
    Lymphocyte Rich
    2
    8%
    Disease Stage at Screening (participants) [Number]
    Stage I
    1
    4%
    Stage II
    8
    32%
    Stage III
    6
    24%
    Stage IV
    10
    40%
    Karnofsky Performance Status (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    83
    (7.1)

    Outcome Measures

    1. Primary Outcome
    Title Overall Response Rate
    Description Overall response rate (ORR) was assessed based on the International Working Group Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), and was defined as the proportion of participants achieving a complete response (CR) or partial response (PR) as assessed by the investigator. CR was defined as the complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease. PR was defined as a ≥ 50% reduction in the sum of the products of the longest perpendicular diameters of all index lesions, with no new lesions.
    Time Frame Up to Week 110

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) Analysis Set: participants who received at least one dose of study drug.
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 25
    Number (95% Confidence Interval) [percentage of participants]
    20.0
    80%
    2. Secondary Outcome
    Title Duration of Response
    Description Duration of response (DOR) was defined as the interval from the first documentation of PR or CR to the earlier of the first documentation of disease progression or death from any cause.
    Time Frame Up to Week 110

    Outcome Measure Data

    Analysis Population Description
    Responding Analysis Set: participants who achieved a best response of CR or PR.
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 5
    Median (95% Confidence Interval) [months]
    8.4
    3. Secondary Outcome
    Title Percent Change From Baseline in the Sum of the Product of the Greatest Perpendicular Diameters (SPD) of Target Lymph Nodes as Documented Radiographically
    Description
    Time Frame Baseline, Week 8, Week 48, and up to Week 110

    Outcome Measure Data

    Analysis Population Description
    ITT Analysis Set
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 25
    Percent Change at Week 8 (n = 24)
    -14.1
    Percent Change at Week 48 (n = 5)
    -45.9
    Best Percent Change from Baseline (n = 24)
    -24.1
    4. Secondary Outcome
    Title Change From Baseline in Fluorodeoxyglucose (FDG) Uptake in Lymph Nodes as Assessed by Positron-emission Tomography (PET)
    Description
    Time Frame Up to Week 110

    Outcome Measure Data

    Analysis Population Description
    An analysis of changes in FDG uptake by the tumor was not conducted due to unavailability of lymph node biopsy samples.
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 0
    5. Secondary Outcome
    Title Time to Response
    Description Time to response (TTR) was defined as the interval from the start of idelalisib treatment to the first documentation of CR or PR.
    Time Frame Up to Week 110

    Outcome Measure Data

    Analysis Population Description
    Responding Analysis Set
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 5
    Median (Full Range) [months]
    2.0
    6. Secondary Outcome
    Title Overall Survival
    Description Overall survival was defined as the time from start of idelalisib treatment to death from any cause.
    Time Frame Up to Week 110

    Outcome Measure Data

    Analysis Population Description
    ITT Analysis Set
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 25
    Median (95% Confidence Interval) [months]
    19.8
    7. Secondary Outcome
    Title Progression Free Survival
    Description Progression free survival (PFS) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression or death from any cause.
    Time Frame Up to Week 110

    Outcome Measure Data

    Analysis Population Description
    ITT Analysis Set
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 25
    Median (95% Confidence Interval) [months]
    2.3
    8. Secondary Outcome
    Title Time to Treatment Failure
    Description Time to treatment failure (TTF) was defined as the interval from the start of idelalisib treatment to the earlier of the first documentation of disease progression, the permanent cessation of idelalisib therapy due to an adverse event, or death from any cause.
    Time Frame Up to Week 110

    Outcome Measure Data

    Analysis Population Description
    No data are presented because time to treatment failure data were not collected.
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 0
    9. Secondary Outcome
    Title Changes in Health-related Quality of Life as Reported Using the Functional Assessment of Cancer Therapy: Lymphoma (FACT-Lym) Questionnaire
    Description Change in health-related quality of life was reported by participants using the FACT-Lym questionnaire assessment tool. Results are presented as the mean (SD) best change from baseline in FACT-Lym total score, which was defined as the highest change score (improvement) after baseline. The FACT-Lym total score is on a scale from 0-168, with higher scores associated with a better quality of life.
    Time Frame Baseline and up to Week 110

    Outcome Measure Data

    Analysis Population Description
    FACT-Lym Evaluable Analysis Set: participants who had sufficient baseline and on-study measurements to provide interpretable results for this endpoint.
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 20
    Mean (Standard Deviation) [units on a scale]
    5.1
    (7.24)
    10. Secondary Outcome
    Title Changes in Performance Status as Documented Using the Karnofsky Performance Criteria for Participants ≥ 16 Years of Age and the Lansky Performance Criteria for Participants < 16 Years of Age
    Description Changes in performance status were assessed using the Karnofsky performance criteria for participants ≥ 16 years of age and the Lansky performance criteria for participants < 16 years of age. Since there were no participants < 16 years of age, only the Karnofsky performance criteria were used. The change in Karnofsky performance status was reported as the best (highest change score) and worst (lowest change score) change from baseline using the Karnofsky performance criteria. The Karnofsky score classifies patients according to their functional impairment. Scores are on a scale from 0-100, the lower the score, the worse the survival for most serious illnesses.
    Time Frame Baseline and up to Week 110

    Outcome Measure Data

    Analysis Population Description
    Participants in the ITT Analysis Set with available data were analyzed.
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 7
    Best Change
    6
    (5.3)
    Worst Change
    -1
    (6.9)
    11. Secondary Outcome
    Title Changes in the Plasma Concentrations of Disease-associated Chemokines and Cytokines
    Description
    Time Frame Up to Week 110

    Outcome Measure Data

    Analysis Population Description
    This analysis was not conducted due to discrepancies with the transfer of samples.
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 0
    12. Secondary Outcome
    Title Overall Safety Profile of Idelalisib
    Description The overall safety of idelalisib was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib), clinically significant abnormal electrocardiograms (ECG), and laboratory abnormalities. "Clinically significant" abnormalities in ECG were as determined by the investigator.
    Time Frame Up to Week 110

    Outcome Measure Data

    Analysis Population Description
    ITT Analysis Set
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 25
    Any AE
    96.0
    384%
    Serious AE
    36.0
    144%
    Grade ≥ 3 AE
    48.0
    192%
    AE related to idelalisib
    76.0
    304%
    AE leading to permanent drug discontinuation
    8.0
    32%
    Clinically significant abnormal ECG at Week 16
    0
    0%
    Grade 3 or 4 hemoglobin
    4.0
    16%
    Grade 3 or 4 neutrophils
    8.0
    32%
    Grade 3 or 4 platelets
    4.0
    16%
    Grade 3 or 4 alanine aminotransferase
    20.0
    80%
    Grade 3 or 4 aspartate aminotransferase
    16.0
    64%
    13. Secondary Outcome
    Title Compliance With Study Drug Dosing as Assessed by Accounting for Used and Unused Drug
    Description
    Time Frame Up to Week 110

    Outcome Measure Data

    Analysis Population Description
    ITT Analysis Set
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 25
    Number of doses dispensed
    463
    (462.3)
    Number of doses taken
    329
    (321.1)
    14. Secondary Outcome
    Title Idelalisib Trough and Peak Plasma Concentration at Week 4
    Description Plasma samples were collected predose (trough) and 1.5 hours postdose (peak). The minimum and maximum value among participants sampled at each time point are presented. Results of less than the lower limit of quantitation (ie, 5 ng/mL) were treated as zero prior to the achievement of the first quantifiable concentration and as missing otherwise.
    Time Frame Predose and 1.5 hours postdose at Week 4

    Outcome Measure Data

    Analysis Population Description
    Participants in the ITT Analysis Set with available data were analyzed.
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    Measure Participants 25
    Trough - minimum (n = 20)
    142
    Trough - maximum (n = 20)
    2120.0
    Peak - minimum (n = 22)
    90.2
    Peak - maximum (n = 22)
    8570.0

    Adverse Events

    Time Frame Up to Week 110
    Adverse Event Reporting Description ITT Analysis Set
    Arm/Group Title Idelalisib
    Arm/Group Description Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
    All Cause Mortality
    Idelalisib
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    Idelalisib
    Affected / at Risk (%) # Events
    Total 9/25 (36%)
    Blood and lymphatic system disorders
    Febrile neutropenia 1/25 (4%)
    Gastrointestinal disorders
    Colitis 1/25 (4%)
    Vomiting 1/25 (4%)
    General disorders
    Pyrexia 1/25 (4%)
    Infections and infestations
    Herpes zoster 1/25 (4%)
    Lung infection 1/25 (4%)
    Pneumonia 1/25 (4%)
    Skin infection 1/25 (4%)
    Investigations
    Platelet count decreased 1/25 (4%)
    Metabolism and nutrition disorders
    Hypocalcaemia 1/25 (4%)
    Hypokalaemia 1/25 (4%)
    Hypomagnesaemia 1/25 (4%)
    Respiratory, thoracic and mediastinal disorders
    Hypoxia 1/25 (4%)
    Pneumonitis 1/25 (4%)
    Productive cough 1/25 (4%)
    Skin and subcutaneous tissue disorders
    Rash maculo-papular 2/25 (8%)
    Surgical and medical procedures
    Hospitalisation 1/25 (4%)
    Other (Not Including Serious) Adverse Events
    Idelalisib
    Affected / at Risk (%) # Events
    Total 24/25 (96%)
    Blood and lymphatic system disorders
    Anaemia 3/25 (12%)
    Leukopenia 4/25 (16%)
    Neutropenia 4/25 (16%)
    Thrombocytopenia 4/25 (16%)
    Cardiac disorders
    Tachycardia 2/25 (8%)
    Gastrointestinal disorders
    Abdominal pain 2/25 (8%)
    Abdominal pain upper 2/25 (8%)
    Constipation 6/25 (24%)
    Diarrhoea 3/25 (12%)
    Dyspepsia 4/25 (16%)
    Nausea 4/25 (16%)
    Vomiting 6/25 (24%)
    General disorders
    Chills 5/25 (20%)
    Fatigue 8/25 (32%)
    Pain 2/25 (8%)
    Pyrexia 6/25 (24%)
    Infections and infestations
    Upper respiratory tract infection 2/25 (8%)
    Injury, poisoning and procedural complications
    Fall 2/25 (8%)
    Investigations
    Alanine aminotransferase increased 5/25 (20%)
    Aspartate aminotransferase increased 6/25 (24%)
    Metabolism and nutrition disorders
    Hyperglycaemia 4/25 (16%)
    Hypoalbuminaemia 2/25 (8%)
    Hypocalcaemia 2/25 (8%)
    Hypokalaemia 2/25 (8%)
    Musculoskeletal and connective tissue disorders
    Back pain 2/25 (8%)
    Muscle spasms 2/25 (8%)
    Musculoskeletal pain 2/25 (8%)
    Myalgia 2/25 (8%)
    Nervous system disorders
    Memory impairment 2/25 (8%)
    Neuropathy peripheral 3/25 (12%)
    Respiratory, thoracic and mediastinal disorders
    Cough 5/25 (20%)
    Dyspnoea 2/25 (8%)
    Skin and subcutaneous tissue disorders
    Night sweats 3/25 (12%)
    Rash 3/25 (12%)
    Vascular disorders
    Hypertension 2/25 (8%)

    Limitations/Caveats

    There were no limitations affecting the analysis or results.

    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 Clinical Trial Disclosures
    Organization Gilead Sciences
    Phone
    Email ClinicalTrialDisclosures@gilead.com
    Responsible Party:
    Gilead Sciences
    ClinicalTrials.gov Identifier:
    NCT01393106
    Other Study ID Numbers:
    • 101-11
    First Posted:
    Jul 13, 2011
    Last Update Posted:
    Nov 19, 2018
    Last Verified:
    Nov 1, 2015