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Continuation Study of the Oral AKT Inhibitor GSK2110183

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ClinicalTrials.gov Identifier: NCT01531894
Recruitment Status : Completed
First Posted : February 13, 2012
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cancer
Intervention Drug: GSK2110183 (afuresertib)
Enrollment 11
Recruitment Details As this was a rollover study, there was no planned number of subjects. Eleven subjects were enrolled and analyzed in the study.
Pre-assignment Details 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.
Arm/Group Title GSK2110183 (Afuresertib)
Hide Arm/Group Description All patients received the GSK2110183 (afuresertib) treatment
Period Title: Overall Study
Started 11
Completed 2
Not Completed 9
Reason Not Completed
Physician Decision             8
Death             1
Arm/Group Title GSK2110183 (Afuresertib)
Hide Arm/Group Description All patients received the GSK2110183 (afuresertib) treatment
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
The 'all treated subjects' population consisted of all subjects that received at least one dose of afuresertib in this rollover study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
60.1  (14.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
8
  72.7%
Male
3
  27.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
 Number Analyzed 11 participants
Asian - East Asian heritage 2
White - White/Caucasian/European heritage 9
1.Primary Outcome
Title Number of Participants With at Least One Adverse Events (AEs)
Hide Description Adverse Events (AEs) includes Summary of adverse events, drug related AEs, Serious adverse events, adverse events leading to study treatment discontinuation and death.
Time Frame from the time of consent until the final study visit up to approx. 76 months
Hide Outcome Measure Data
Hide Analysis Population Description
The 'all treated subjects' population consisted of all subjects that received at least one dose of afuresertib in this rollover study.
Arm/Group Title GSK2110183 (Afuresertib)
Hide Arm/Group Description:
All patients received the GSK2110183 (afuresertib) treatment
Overall Number of Participants Analyzed 11
Measure Type: Count of Participants
Unit of Measure: Participants
11
 100.0%
Time Frame 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.
Adverse Event Reporting Description 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.
 
Arm/Group Title All Patients
Hide Arm/Group Description All patients received the GSK2110183 (afuresertib) treatment
All-Cause Mortality
All Patients
Affected / at Risk (%)
Total   1/11 (9.09%) 
Hide Serious Adverse Events
All Patients
Affected / at Risk (%)
Total   2/11 (18.18%) 
Gastrointestinal disorders   
Gastritis † 1  1/11 (9.09%) 
Infections and infestations   
Pneumonia † 1  1/11 (9.09%) 
1
Term from vocabulary, MedDRA (19.1)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
All Patients
Affected / at Risk (%)
Total   11/11 (100.00%) 
Blood and lymphatic system disorders   
Anaemia † 1  1/11 (9.09%) 
Lymphopenia † 1  1/11 (9.09%) 
Neutropenia † 1  2/11 (18.18%) 
Cardiac disorders   
Palpitations † 1  1/11 (9.09%) 
Ear and labyrinth disorders   
Ear discomfort † 1  1/11 (9.09%) 
Gastrointestinal disorders   
Abdominal discomfort † 1  1/11 (9.09%) 
Abdominal distension † 1  1/11 (9.09%) 
Diarrhoea † 1  7/11 (63.64%) 
Gastrooesophageal reflux disease † 1  1/11 (9.09%) 
Large intestine polyp † 1  1/11 (9.09%) 
Nausea † 1  1/11 (9.09%) 
Oesophageal discomfort † 1  1/11 (9.09%) 
Oesophageal pain † 1  1/11 (9.09%) 
Tooth disorder † 1  1/11 (9.09%) 
Vomiting † 1  2/11 (18.18%) 
General disorders   
Asthenia † 1  1/11 (9.09%) 
Chest discomfort † 1  2/11 (18.18%) 
Fatigue † 1  5/11 (45.45%) 
Oedema † 1  1/11 (9.09%) 
Oedema peripheral † 1  1/11 (9.09%) 
Peripheral swelling † 1  1/11 (9.09%) 
Infections and infestations   
Chronic sinusitis † 1  1/11 (9.09%) 
Conjunctivitis † 1  1/11 (9.09%) 
Helicobacter infection † 1  1/11 (9.09%) 
Nasopharyngitis † 1  1/11 (9.09%) 
Respiratory tract infection † 1  1/11 (9.09%) 
Sinusitis † 1  1/11 (9.09%) 
Tooth infection † 1  1/11 (9.09%) 
Upper respiratory tract infection † 1  2/11 (18.18%) 
Urinary tract infection † 1  2/11 (18.18%) 
Metabolism and nutrition disorders   
Decreased appetite † 1  2/11 (18.18%) 
Hyperglycaemia † 1  1/11 (9.09%) 
Musculoskeletal and connective tissue disorders   
Foot deformity † 1  1/11 (9.09%) 
Muscle spasms † 1  1/11 (9.09%) 
Temporomandibular joint syndrome † 1  1/11 (9.09%) 
Nervous system disorders   
Ageusia † 1  1/11 (9.09%) 
Anosmia † 1  1/11 (9.09%) 
Dizziness † 1  1/11 (9.09%) 
Paraesthesia † 1  1/11 (9.09%) 
Renal and urinary disorders   
Micturition urgency † 1  1/11 (9.09%) 
Nephrolithiasis † 1  1/11 (9.09%) 
Respiratory, thoracic and mediastinal disorders   
Cough † 1  3/11 (27.27%) 
Dyspnoea † 1  1/11 (9.09%) 
Epistaxis † 1  2/11 (18.18%) 
Nasal congestion † 1  2/11 (18.18%) 
Skin and subcutaneous tissue disorders   
Erythema † 1  1/11 (9.09%) 
Pruritus † 1  2/11 (18.18%) 
Pruritus generalised † 1  1/11 (9.09%) 
Rash † 1  1/11 (9.09%) 
Skin ulcer † 1  1/11 (9.09%) 
Vascular disorders   
Hypertension † 1  1/11 (9.09%) 
Raynaud's phenomenon † 1  1/11 (9.09%) 
1
Term from vocabulary, MedDRA (19.1)
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: novartis.email@novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01531894    
Other Study ID Numbers: 115131
2014-002041-22 ( EudraCT Number )
First Submitted: February 9, 2012
First Posted: February 13, 2012
Results First Submitted: June 20, 2019
Results First Posted: July 9, 2019
Last Update Posted: July 9, 2019