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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002041-22 | EudraCT Number |
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This multicenter, non-randomized, open-label, treatment continuation or 'rollover' study was designed to provide continued access to eligible subjects who had previously participated in a GSK2110183 study (parent study) sponsored by GlaxoSmithKline (GSK) or another research organization working on behalf of GSK. Eligible subjects had previously received clinical benefit from continued treatment and had to have ad an acceptable safety profile with GSK2110183. Subjects who had participated in a GSK2110183 combination study with an approved anti-cancer agent were also be eligible to enroll in this rollover study. Subjects who participated in combination studies with two investigational compounds (one being GSK2110183) were not eligible for this rollover study. Subjects were enrolled by cohort based on the duration and treatment received while in their parent study. Safety assessments (physical examinations, vital sign measurements, 12-lead electrocardiograms, echocardiograms or multiple-gated acquisition scans, clinical laboratory assessments and monitoring of adverse events) were evaluated during this study. Disease assessment were performed using local standard of care imaging practices and criteria appropriate for disease type and location.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2110183 (afuresertib) | Experimental | All patients received the GSK2110183 (afuresertib) treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK2110183 (afuresertib) | Drug | Afuresertib is an oral, low nanomolar pan-AKT kinase inhibitor immediate release (IR) 50 mg or 75 mg tablets was to be taken orally with at least 200 mL of water, with or without food, in the morning. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least One Adverse Events (AEs) | Adverse Events (AEs) includes Summary of adverse events, drug related AEs, Serious adverse events, adverse events leading to study treatment discontinuation and death. | from the time of consent until the final study visit up to approx. 76 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Baltimore | Maryland | 21231 | United States | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data is currently available according to the process described on www.clinicalstudydatarequest.com.
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There was no planned duration of treatment as this was a rollover study. The subjects could permanently discontinue the study treatment due to protocol deviation, adverse event, disease progression, withdrawal of consent, Investigator's discretion, lost to follow-up, termination of study or death.
As this was a rollover study, there was no planned number of subjects. Eleven subjects were enrolled and analyzed in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK2110183 (Afuresertib) | All patients received the GSK2110183 (afuresertib) treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The 'all treated subjects' population consisted of all subjects that received at least one dose of afuresertib in this rollover study.
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK2110183 (Afuresertib) | All patients received the GSK2110183 (afuresertib) treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 With at Least One Adverse Events (AEs) | Adverse Events (AEs) includes Summary of adverse events, drug related AEs, Serious adverse events, adverse events leading to study treatment discontinuation and death. | The 'all treated subjects' population consisted of all subjects that received at least one dose of afuresertib in this rollover study. | Posted | Count of Participants | Participants | from the time of consent until the final study visit up to approx. 76 months |
|
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Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 2239 days.
All cause mortality (deaths) was collected for as long as participants could be contacted from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV) up to a maximum of about 76 months.
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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 | All Patients | All patients received the GSK2110183 (afuresertib) treatment | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastritis | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | novartis.email@novartis.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 | Mar 31, 2016 | Jun 20, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 27, 2017 | Jun 20, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000595148 | GSK2110183 |
| C000593263 | afuresertib |
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|
| Boston |
| Massachusetts |
| 02115 |
| United States |
| Novartis Investigative Site | New York | New York | 10029 | United States |
| Novartis Investigative Site | New York | New York | 10065 | United States |
| Novartis Investigative Site | Melbourne | Victoria | 3004 | Australia |
| Novartis Investigative Site | Toronto | Ontario | M5G 1Z6 | Canada |
| Novartis Investigative Site | Galway | Ireland |
| Novartis Investigative Site | Seoul | 110-744 | South Korea |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Participants |
|
|
| 11 |
| 2 |
| 11 |
| 11 |
| 11 |
| Pneumonia | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA (19.1) | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA (19.1) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Large intestine polyp | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Oesophageal discomfort | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Tooth disorder | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (19.1) | Systematic Assessment |
|
| Chronic sinusitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Helicobacter infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (19.1) | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (19.1) | Systematic Assessment |
|
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Anosmia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (19.1) | Systematic Assessment |
|
| Micturition urgency | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (19.1) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (19.1) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (19.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
| Raynaud's phenomenon | Vascular disorders | MedDRA (19.1) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.