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Roll Over Study to Provide Idelalisib to Participants Previously Treated With the Investigational PI3Kδ Inhibitor, GS-9820

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ClinicalTrials.gov Identifier: NCT02739360
Recruitment Status : Terminated
First Posted : April 15, 2016
Results First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Lymphoid Malignancies
Intervention Drug: Idelalisib
Enrollment 3
Recruitment Details Participants were enrolled at study sites in the Netherlands. The first participant was screened on 04 May 2016. The last study visit occurred on 28 December 2017.
Pre-assignment Details Six participants previously enrolled in Study GS-US-315-0102 were offered screening for enrollment into this study.
Arm/Group Title Idelalisib
Hide Arm/Group Description Idelalisib 150 mg tablet administered orally twice daily.
Period Title: Overall Study
Started 3
Completed 0
Not Completed 3
Reason Not Completed
Adverse Event             1
Study terminated by Sponsor             2
Arm/Group Title Idelalisib
Hide Arm/Group Description Idelalisib 150 mg tablet administered orally twice daily.
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
Safety Analysis Set: participants who took at least 1 dose of study drug.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
From 65 - 84 years Number Analyzed 3 participants
3
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths
Hide Description The severity of Adverse Events were graded using the Common Terminology Criteria for Adverse Events (CTCAE), Version 4.03. An SAE was defined as an event that, at any dose, resulted in one or more of the following: 1) Death, 2) Life-threatening, 3) In-patient hospitalization or prolongation of existing hospitalization, 4) Persistent or significant disability/incapacity, 5) A congenital anomaly/birth defect, or 6) A medically important event or reaction.
Time Frame Up to Day 602 plus 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Analysis Set: participants who took at least 1 dose of study drug.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet administered orally twice daily.
Overall Number of Participants Analyzed 3
Measure Type: Number
Unit of Measure: Participants
≥ Grade 3 Adverse Event 1
SAE 1
Death 0
Time Frame Up to Day 602 plus 30 days
Adverse Event Reporting Description Safety Analysis Set: participants who took at least 1 dose of study drug.
 
Arm/Group Title Idelalisib
Hide Arm/Group Description Idelalisib 150 mg tablet administered orally twice daily.
All-Cause Mortality
Idelalisib
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Idelalisib
Affected / at Risk (%)
Total   1/3 (33.33%) 
Hepatobiliary disorders   
Cholangitis  1  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders   
Lung disorder  1  1/3 (33.33%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Idelalisib
Affected / at Risk (%)
Total   3/3 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  1/3 (33.33%) 
Eye disorders   
Vision blurred  1  1/3 (33.33%) 
Gastrointestinal disorders   
Abdominal distension  1  1/3 (33.33%) 
Constipation  1  1/3 (33.33%) 
Diarrhoea  1  1/3 (33.33%) 
Dry mouth  1  1/3 (33.33%) 
Nausea  1  1/3 (33.33%) 
General disorders   
Fatigue  1  1/3 (33.33%) 
Influenza like illness  1  1/3 (33.33%) 
Oedema peripheral  1  1/3 (33.33%) 
Pyrexia  1  1/3 (33.33%) 
Infections and infestations   
Urinary tract infection  1  3/3 (100.00%) 
Investigations   
Aspartate aminotransferase increased  1  1/3 (33.33%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/3 (33.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma  1  1/3 (33.33%) 
Nervous system disorders   
Dizziness  1  1/3 (33.33%) 
Neuralgia  1  1/3 (33.33%) 
Psychiatric disorders   
Delirium  1  1/3 (33.33%) 
Renal and urinary disorders   
Renal impairment  1  1/3 (33.33%) 
Respiratory, thoracic and mediastinal disorders   
Bronchitis chronic  1  1/3 (33.33%) 
Skin and subcutaneous tissue disorders   
Skin ulcer  1  1/3 (33.33%) 
Vascular disorders   
Intermittent claudication  1  1/3 (33.33%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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)
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02739360     History of Changes
Other Study ID Numbers: GS-US-313-2120
2015-005766-39 ( EudraCT Number )
First Submitted: April 12, 2016
First Posted: April 15, 2016
Results First Submitted: December 17, 2018
Results First Posted: January 16, 2019
Last Update Posted: January 16, 2019