Trial Outcomes & Findings for GSK1120212 Rollover Study (NCT NCT01376310)

NCT ID: NCT01376310

Last Updated: 2019-02-19

Results Overview

Number of participants with adverse events as a measure of safety and tolerability

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

159 participants

Primary outcome timeframe

Until 30 days after the last dose of study treatment. Subjects may have continued to receive study treatment until disease progression, death, unacceptable toxicity or until locally commercially available. The maximum duration of exposure was 76 months.

Results posted on

2019-02-19

Participant Flow

159 subjects received treatment with GSK1120212 and were included in the safety set.

Continued treatment with GSK1120212 was provided for subjects who had previously participated in a GSK1120212 study and who continued to receive clinical benefit as well as have an acceptable safety profile with GSK1120212.

Participant milestones

Participant milestones
Measure	Cohort A (GSK1120212 < 24 Weeks) Subjects on GSK1120212 Monotherapy and have been treated less than 24 weeks in their parent study.	Cohort B (GSK1120212 >= 24 Weeks) Subjects on GSK monotherapy who have been treated for 24 weeks or greater in their parent study. Also, subjects entering this study from any GSK1120212 combo trial.
Overall Study STARTED	126	33
Overall Study COMPLETED	90	22
Overall Study NOT COMPLETED	36	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A (GSK1120212 < 24 Weeks) Subjects on GSK1120212 Monotherapy and have been treated less than 24 weeks in their parent study.	Cohort B (GSK1120212 >= 24 Weeks) Subjects on GSK monotherapy who have been treated for 24 weeks or greater in their parent study. Also, subjects entering this study from any GSK1120212 combo trial.
Overall Study Study closed/terminated	1	2
Overall Study Withdrawal by Subject	8	2
Overall Study Physician Decision	26	7
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

GSK1120212 Rollover Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A (GSK1120212 < 24 Weeks) n=126 Participants Subjects on GSK1120212 Monotherapy and have been treated less than 24 weeks in their parent study.	Cohort B (GSK1120212 >= 24 Weeks) n=33 Participants Subjects on GSK monotherapy who have been treated for 24 weeks or greater in their parent study. Also, subjects entering this study from any GSK1120212 combo trial.	Total n=159 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 12.34 • n=5 Participants	61.7 years STANDARD_DEVIATION 11.30 • n=7 Participants	61.2 years STANDARD_DEVIATION 12.10 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	17 Participants n=7 Participants	83 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	16 Participants n=7 Participants	76 Participants n=5 Participants
Race/Ethnicity, Customized White	116 Participants n=5 Participants	28 Participants n=7 Participants	144 Participants n=5 Participants
Race/Ethnicity, Customized Black	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Native American/Pacific Islander	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Until 30 days after the last dose of study treatment. Subjects may have continued to receive study treatment until disease progression, death, unacceptable toxicity or until locally commercially available. The maximum duration of exposure was 76 months.

Population: Safety Set

Number of participants with adverse events as a measure of safety and tolerability

Outcome measures

Outcome measures
Measure	Cohort A (GSK1120212 < 24 Weeks) n=126 Participants Subjects on GSK1120212 Monotherapy and have been treated less than 24 weeks in their parent study.	Cohort B (GSK1120212 >= 24 Weeks) n=33 Participants Subjects on GSK monotherapy who have been treated for 24 weeks or greater in their parent study. Also, subjects entering this study from any GSK1120212 combo trial.
Number of Participants With Adverse Events Adverse Events	119 Participants	30 Participants
Number of Participants With Adverse Events Treatment-Related Adverse Events	101 Participants	26 Participants
Number of Participants With Adverse Events Serious Adverse Events	26 Participants	13 Participants
Number of Participants With Adverse Events Treatment-Related Serious Adverse Events	8 Participants	4 Participants

Adverse Events

Cohort A (GSK1120212 < 24 Weeks)

Serious events: 26 serious events

Other events: 115 other events

Deaths: 13 deaths

Cohort B (GSK1120212 >= 24 Weeks)

Serious events: 13 serious events

Other events: 28 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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 the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	Cohort A (GSK1120212 < 24 Weeks) n=126 participants at risk Subjects on GSK1120212 Monotherapy and have been treated less than 24 weeks in their parent study.	Cohort B (GSK1120212 >= 24 Weeks) n=33 participants at risk Subjects on GSK monotherapy who have been treated for 24 weeks or greater in their parent study. Also, subjects entering this study from any GSK1120212 combo trial.
Cardiac disorders Acute myocardial infarction	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Cardiac disorders Bradycardia	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Cardiac disorders Cardiac arrest	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Cardiac disorders Left ventricular dysfunction	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Eye disorders Retinal vein occlusion	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Gastrointestinal disorders Abdominal hernia	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Gastrointestinal disorders Diarrhoea	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	6.1% 2/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Gastrointestinal disorders Intestinal obstruction	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Gastrointestinal disorders Intestinal perforation	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Gastrointestinal disorders Intra-abdominal fluid collection	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Gastrointestinal disorders Nausea	1.6% 2/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Gastrointestinal disorders Pancreatitis	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Gastrointestinal disorders Small intestinal obstruction	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Gastrointestinal disorders Vomiting	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
General disorders General physical health deterioration	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
General disorders Generalised oedema	1.6% 2/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
General disorders Pyrexia	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Hepatobiliary disorders Hepatitis acute	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Cellulitis	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Clostridium difficile infection	1.6% 2/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Erysipelas	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Gastroenteritis	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Influenza	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Klebsiella sepsis	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Liver abscess	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Moraxella infection	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Pneumonia	1.6% 2/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	9.1% 3/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Pyelonephritis	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Sepsis	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Urinary tract infection	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Infections and infestations Wound infection	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Injury, poisoning and procedural complications Fall	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Injury, poisoning and procedural complications Pelvic fracture	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Investigations Blood bilirubin increased	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Investigations Blood creatinine increased	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Investigations Ejection fraction decreased	1.6% 2/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Metabolism and nutrition disorders Dehydration	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Musculoskeletal and connective tissue disorders Back pain	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Nervous system disorders Sciatica	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Nervous system disorders Seizure	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Psychiatric disorders Adjustment disorder with depressed mood	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Renal and urinary disorders Acute kidney injury	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.79% 1/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	0.00% 0/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.6% 2/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	6.1% 2/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	6.1% 2/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	6.1% 2/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	6.1% 2/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).
Skin and subcutaneous tissue disorders Purpura	0.00% 0/126 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).	3.0% 1/33 • From date of transition into this Rollover study until 30 days following the last dose (up to 76 months from date of transition).