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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005766-39 | EudraCT Number |
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The primary objective of this study is to provide idelalisib to participants receiving GS-9820 in Gilead-sponsored Study GS-US-315-0102 at the time of study closure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Idelalisib | Experimental | Participants will receive idelalisib until unacceptable toxicity, disease progression, study discontinuation, or death occurs. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Idelalisib | Drug | Idelalisib 150 mg tablet administered orally twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths | 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. | Up to Day 602 plus 30 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/ Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam | Netherlands |
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.
18 months after study completion
A secured external environment with username, password, and RSA code.
Six participants previously enrolled in Study GS-US-315-0102 were offered screening for enrollment into this study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Idelalisib | Idelalisib 150 mg tablet administered orally twice daily. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety Analysis Set: participants who took at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Idelalisib | Idelalisib 150 mg tablet administered orally twice daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of 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 | Number of Participants Experiencing Treatment-Emergent ≥ Grade 3 Adverse Events, Serious Adverse Events (SAEs), and Deaths | 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. | Safety Analysis Set: participants who took at least 1 dose of study drug. | Posted | Number | Participants | Up to Day 602 plus 30 days |
|
Up to Day 602 plus 30 days
Safety Analysis Set: participants who took at least 1 dose of study drug.
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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 administered orally twice daily. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholangitis | Hepatobiliary disorders | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Gilead Sciences | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Original | Jan 5, 2016 | Nov 16, 2018 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 1 | Mar 28, 2016 | Nov 16, 2018 | Prot_001.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 2 | Aug 26, 2016 | Nov 16, 2018 | Prot_002.pdf |
| Prot | Yes | No | No | Study Protocol: Amendment 3 | Nov 4, 2016 | Nov 16, 2018 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 21, 2018 | Nov 16, 2018 | SAP_004.pdf |
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| ID | Term |
|---|---|
| C552946 | idelalisib |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 3 |
| 1 |
| 3 |
| 3 |
| 3 |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 20.1 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Neuralgia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Delirium | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
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| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
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| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
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| Intermittent claudication | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
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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: