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Safety and Efficacy Study of Idelalisib (GS-1101, CAL-101) in Patients With Previously Treated Low-grade Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01306643
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : December 21, 2016
Last Update Posted : November 19, 2018
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
Conditions Indolent Non-Hodgkin's Lymphoma
Follicular Lymphoma
Small Lymphocytic Lymphoma
Marginal Zone Lymphoma
Intervention Drug: Idelalisib
Enrollment 18
Recruitment Details Participants were enrolled at 2 study sites in the United States. The first participant was screened on 22 February 2011. The last study visit occurred on 24 August 2015.
Pre-assignment Details 24 participants were screened.
Arm/Group Title Idelalisib
Hide Arm/Group Description Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
Period Title: Overall Study
Started 18
Completed 5 [1]
Not Completed 13
Reason Not Completed
Adverse Event             5
Disease Progression             7
Other: Change in Eligibility Status             1
[1]
Completed Study was defined as participants who completed through Cycle 12 (Week 48) per protocol.
Arm/Group Title Idelalisib
Hide Arm/Group Description Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) Analysis Set: all enrolled participants who received at least 1 dose of idelalisib.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants
58  (12.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
8
  44.4%
Male
10
  55.6%
Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 18 participants
Follicular lymphoma 10
Marginal zone lymphoma 3
Small lymphocytic lymphoma 4
Missing 1
1.Primary Outcome
Title Overall Safety of Idelalisib
Hide Description The overall safety of idelalisib was assessed as the percentage of participants experiencing treatment-emergent adverse events (AEs; Serious AEs, Grade ≥ 3 AEs, AEs related to idelalisib, and AEs leading to discontinuation of idelalisib).
Time Frame 30 days post last study treatment (up to 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Analysis Set: all enrolled participants who received at least 1 dose of idelalisib.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of participants
Any AE 88.9
Serious AE 27.8
Grade ≥ 3 AE 55.6
AE related to idelalisib 83.3
AE leading to permanent drug discontinuation 27.8
2.Primary Outcome
Title Clinical Response: Overall Response Rate
Hide Description

Participants were assessed for clinical response by appropriate imaging at the end of cycles 3, 6, 9, and 12.

Overall response rate (ORR) was assessed based on standardized criteria (Cheson 2007), and was defined as the percentage of participants who achieved a complete response (CR) or partial response (PR) based on investigator assessment after the start of idelalisib treatment until progression or the end of study drug treatment.

  • CR was defined as the disappearance of all evidence of disease.
  • PR was defined the regression of measurable disease and no new sites.
Time Frame Up to twelve 28-day cycles (maximum of 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
Overall Number of Participants Analyzed 18
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
44.4
(21.5 to 69.2)
3.Secondary Outcome
Title Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells
Hide Description [Not Specified]
Time Frame Up to twelve 28-day cycles (maximum of 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells
Hide Description [Not Specified]
Time Frame Up to twelve 28-day cycles (maximum of 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Changes in Concentration of Peripheral Blood Chemokines and Cytokines
Hide Description [Not Specified]
Time Frame Up to twelve 28-day cycles (maximum of 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast
Hide Description [Not Specified]
Time Frame Up to twelve 28-day cycles (maximum of 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead.
Arm/Group Title Idelalisib
Hide Arm/Group Description:
Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 30 days post last study treatment (up to 12 months)
Adverse Event Reporting Description ITT Analysis Set
 
Arm/Group Title Idelalisib
Hide Arm/Group Description Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
All-Cause Mortality
Idelalisib
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Idelalisib
Affected / at Risk (%)
Total   5/18 (27.78%) 
Cardiac disorders   
Atrial fibrillation  1  1/18 (5.56%) 
Gastrointestinal disorders   
Gastrointestinal haemorrhage  1  1/18 (5.56%) 
Infections and infestations   
Cellulitis  1  1/18 (5.56%) 
Sepsis  1  1/18 (5.56%) 
Investigations   
Alanine aminotransferase increased  1  1/18 (5.56%) 
Aspartate aminotransferase increased  1  1/18 (5.56%) 
Transaminases increased  1  1/18 (5.56%) 
Metabolism and nutrition disorders   
Tumour lysis syndrome  1  2/18 (11.11%) 
Renal and urinary disorders   
Renal failure  1  2/18 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1  1/18 (5.56%) 
Pneumonitis  1  1/18 (5.56%) 
Pneumothorax  1  1/18 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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   15/18 (83.33%) 
Blood and lymphatic system disorders   
Neutropenia  1  3/18 (16.67%) 
Thrombocytopenia  1  2/18 (11.11%) 
Cardiac disorders   
Atrial fibrillation  1  1/18 (5.56%) 
Atrial tachycardia  1  1/18 (5.56%) 
Palpitations  1  1/18 (5.56%) 
Ear and labyrinth disorders   
Vertigo  1  2/18 (11.11%) 
Eye disorders   
Blepharospasm  1  1/18 (5.56%) 
Chalazion  1  1/18 (5.56%) 
Conjunctival hyperaemia  1  1/18 (5.56%) 
Keratitis  1  1/18 (5.56%) 
Photopsia  1  1/18 (5.56%) 
Vision blurred  1  1/18 (5.56%) 
Gastrointestinal disorders   
Abdominal discomfort  1  1/18 (5.56%) 
Abdominal pain  1  2/18 (11.11%) 
Colitis  1  1/18 (5.56%) 
Constipation  1  3/18 (16.67%) 
Diarrhoea  1  8/18 (44.44%) 
Flatulence  1  3/18 (16.67%) 
Gastrointestinal pain  1  1/18 (5.56%) 
Gastrooesophageal reflux disease  1  1/18 (5.56%) 
Haemorrhoidal haemorrhage  1  1/18 (5.56%) 
Lip discolouration  1  1/18 (5.56%) 
Nausea  1  7/18 (38.89%) 
Oral pain  1  1/18 (5.56%) 
Painful defaecation  1  1/18 (5.56%) 
Paraesthesia oral  1  1/18 (5.56%) 
Vomiting  1  5/18 (27.78%) 
General disorders   
Asthenia  1  2/18 (11.11%) 
Chest pain  1  1/18 (5.56%) 
Chills  1  2/18 (11.11%) 
Fatigue  1  8/18 (44.44%) 
Influenza like illness  1  2/18 (11.11%) 
Malaise  1  2/18 (11.11%) 
Pain  1  2/18 (11.11%) 
Pyrexia  1  5/18 (27.78%) 
Hepatobiliary disorders   
Hyperbilirubinaemia  1  1/18 (5.56%) 
Infections and infestations   
Atypical pneumonia  1  1/18 (5.56%) 
Candida infection  1  1/18 (5.56%) 
Conjunctivitis  1  1/18 (5.56%) 
Hordeolum  1  1/18 (5.56%) 
Nasopharyngitis  1  2/18 (11.11%) 
Upper respiratory tract infection  1  4/18 (22.22%) 
Injury, poisoning and procedural complications   
Contusion  1  2/18 (11.11%) 
Fall  1  1/18 (5.56%) 
Investigations   
Alanine aminotransferase increased  1  8/18 (44.44%) 
Aspartate aminotransferase increased  1  8/18 (44.44%) 
Blood bilirubin increased  1  2/18 (11.11%) 
Blood creatinine increased  1  1/18 (5.56%) 
Blood phosphorus increased  1  1/18 (5.56%) 
Blood uric acid increased  1  1/18 (5.56%) 
Glomerular filtration rate decreased  1  1/18 (5.56%) 
Hepatic enzyme increased  1  1/18 (5.56%) 
Neutrophil count decreased  1  1/18 (5.56%) 
Transaminases increased  1  4/18 (22.22%) 
Weight decreased  1  2/18 (11.11%) 
Metabolism and nutrition disorders   
Decreased appetite  1  3/18 (16.67%) 
Dehydration  1  1/18 (5.56%) 
Hyperuricaemia  1  1/18 (5.56%) 
Hypokalaemia  1  1/18 (5.56%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  2/18 (11.11%) 
Back pain  1  2/18 (11.11%) 
Flank pain  1  1/18 (5.56%) 
Haemarthrosis  1  1/18 (5.56%) 
Joint stiffness  1  1/18 (5.56%) 
Muscle spasms  1  2/18 (11.11%) 
Muscular weakness  1  1/18 (5.56%) 
Musculoskeletal pain  1  1/18 (5.56%) 
Pain in extremity  1  3/18 (16.67%) 
Nervous system disorders   
Dysgeusia  1  3/18 (16.67%) 
Headache  1  4/18 (22.22%) 
Hypersomnia  1  1/18 (5.56%) 
Lethargy  1  2/18 (11.11%) 
Mental impairment  1  1/18 (5.56%) 
Neuropathy peripheral  1  1/18 (5.56%) 
Sinus headache  1  1/18 (5.56%) 
Psychiatric disorders   
Agitation  1  2/18 (11.11%) 
Confusional state  1  1/18 (5.56%) 
Emotional disorder  1  1/18 (5.56%) 
Insomnia  1  5/18 (27.78%) 
Renal and urinary disorders   
Chromaturia  1  1/18 (5.56%) 
Dysuria  1  1/18 (5.56%) 
Nocturia  1  1/18 (5.56%) 
Pollakiuria  1  1/18 (5.56%) 
Renal failure  1  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  4/18 (22.22%) 
Dysphonia  1  1/18 (5.56%) 
Dyspnoea  1  2/18 (11.11%) 
Hypopnoea  1  1/18 (5.56%) 
Nasal congestion  1  1/18 (5.56%) 
Oropharyngeal pain  1  1/18 (5.56%) 
Pneumonitis  1  2/18 (11.11%) 
Productive cough  1  1/18 (5.56%) 
Skin and subcutaneous tissue disorders   
Acne  1  1/18 (5.56%) 
Exfoliative rash  1  3/18 (16.67%) 
Hyperhidrosis  1  2/18 (11.11%) 
Hyperkeratosis  1  1/18 (5.56%) 
Pruritus  1  3/18 (16.67%) 
Rash  1  5/18 (27.78%) 
Skin fissures  1  1/18 (5.56%) 
Vascular disorders   
Hot flush  1  1/18 (5.56%) 
Hypotension  1  1/18 (5.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
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: Clinical Trial Disclosures
Organization: Gilead Sciences
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01306643     History of Changes
Other Study ID Numbers: 101-10
First Submitted: February 25, 2011
First Posted: March 2, 2011
Results First Submitted: August 23, 2016
Results First Posted: December 21, 2016
Last Update Posted: November 19, 2018