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The primary objectives of this study is to evaluate the safety and efficacy of idelalisib (GS-1101, CAL-101) in participants with previously treated indolent non-Hodgkin lymphoma (iNHL).
Eligible patients will initiate oral therapy with idelalisib at a starting dose of 150 mg twice per day. Treatment with idelalisib can continue in compliant participants for up to twelve 28-day cycles of idelalisib. Participants who appear to be benefiting from treatment at the completion of 12 cycles of treatment with idelalisib may be eligible for participation in a long-term safety extension study of idelalisib.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idelalisib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idelalisib | Drug | Tablet(s) administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Safety of Idelalisib | 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). | 30 days post last study treatment (up to 12 months) |
| Clinical Response: Overall Response Rate | 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.
| Up to twelve 28-day cycles (maximum of 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells | Up to twelve 28-day cycles (maximum of 12 months) | |
| Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells | Up to twelve 28-day cycles (maximum of 12 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Palo Alto | California | 94304-5548 | United States | ||
| Mount Sinai School of Medicine |
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
18 months after study completion
A secured external environment with username, password, and RSA code.
24 participants were screened.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Idelalisib | Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Changes in Concentration of Peripheral Blood Chemokines and Cytokines | Up to twelve 28-day cycles (maximum of 12 months) |
| Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast | Up to twelve 28-day cycles (maximum of 12 months) |
| New York |
| New York |
| 10029 |
| United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-treat (ITT) Analysis Set: all enrolled participants who received at least 1 dose of idelalisib.
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| ID | Title | Description |
|---|---|---|
| BG000 | Idelalisib | Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Diagnosis | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Safety of Idelalisib | 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). | Intent-to-treat (ITT) Analysis Set: all enrolled participants who received at least 1 dose of idelalisib. | Posted | Number | percentage of participants | 30 days post last study treatment (up to 12 months) |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Clinical Response: Overall Response Rate | 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.
| ITT Analysis Set | Posted | Number | 95% Confidence Interval | percentage of participants | Up to twelve 28-day cycles (maximum of 12 months) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Flow Cytometric Measurement of Constitutive or Inducible Phosphorylation of Akt (at S473) and S6 Within Tumor B Cells | Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead. | Posted | Up to twelve 28-day cycles (maximum of 12 months) |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Flow Cytometric Measurement of Tumoral and Peripheral Blood T and NK Cells | Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead. | Posted | Up to twelve 28-day cycles (maximum of 12 months) |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Concentration of Peripheral Blood Chemokines and Cytokines | Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead. | Posted | Up to twelve 28-day cycles (maximum of 12 months) |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes in Liver Imaging as Assessed by Magnetic Resonance Imaging (MRI) and Gadoxetic Acid (GD-EOB-DTPA) Contrast | Data are not available because the samples and analysis results (performed at the sites) could not be retrieved by Gilead. | Posted | Up to twelve 28-day cycles (maximum of 12 months) |
|
|
30 days post last study treatment (up to 12 months)
ITT Analysis Set
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Idelalisib | Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles | 5 | 18 | 15 | 18 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
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| Blepharospasm | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Chalazion | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Keratitis | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Photopsia | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lip discolouration | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oral pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Painful defaecation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Malaise | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
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| Atypical pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Candida infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Hypersomnia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Mental impairment | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Neuropathy peripheral | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Emotional disorder | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
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| Chromaturia | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Exfoliative rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
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:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D018442 | Lymphoma, B-Cell, Marginal Zone |
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D006402 | Hematologic Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016393 | Lymphoma, B-Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| C552946 | idelalisib |
Not provided
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| Small lymphocytic lymphoma |
|
| Missing |
|
| Title | Measurements |
|---|---|
|
| AE related to idelalisib |
|
| AE leading to permanent drug discontinuation |
|
|