Trial Outcomes & Findings for Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum (NCT NCT01355497)

NCT ID: NCT01355497

Last Updated: 2020-11-09

Results Overview

Measure is the percentage of subjects at day 84 with stair climb power change \>=10% from their baseline value.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

330 participants

Primary outcome timeframe

Day 84

Results posted on

2020-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	GTx-024 3mg Once Daily subjects will be randomized to receive GTx-024 for the duration of the trial GTx-024: subjects will be randomized to receive GTx-024 for the duration of the trial.	Placebo subjects will be randomized to matching placebo once daily for the duration of the trial placebo: subject will receive placebo for the duration of the trial
Overall Study STARTED	165	165
Overall Study COMPLETED	99	102
Overall Study NOT COMPLETED	66	63

Reasons for withdrawal

Reasons for withdrawal
Measure	GTx-024 3mg Once Daily subjects will be randomized to receive GTx-024 for the duration of the trial GTx-024: subjects will be randomized to receive GTx-024 for the duration of the trial.	Placebo subjects will be randomized to matching placebo once daily for the duration of the trial placebo: subject will receive placebo for the duration of the trial
Overall Study Death	19	18
Overall Study Lost to Follow-up	3	0
Overall Study Protocol Violation	0	1
Overall Study other-not provided	9	4
Overall Study Withdrawal by Subject	12	20
Overall Study noncompliance	1	2
Overall Study progressive disease	11	8
Overall Study Adverse Event	11	10

Baseline Characteristics

Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GTx-024 n=159 Participants subjects will be randomized to receive GTx-024 for the duration of the trail GTx-024: subjects will be randomized to receive GTx-024 for the duration of the trial.	Placebo n=161 Participants subjects will be randomized to receive placebo for the duration of the trial placebo: subject will receive placebo for the duration of the trial	Total n=320 Participants Total of all reporting groups
Age, Continuous	60.0 years n=5 Participants	62.0 years n=7 Participants	61.0 years n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	48 Participants n=7 Participants	93 Participants n=5 Participants
Sex: Female, Male Male	114 Participants n=5 Participants	113 Participants n=7 Participants	227 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 84

Population: Subjects included in the Full Analysis Set

Measure is the percentage of subjects at day 84 with stair climb power change \>=10% from their baseline value.

Outcome measures

Outcome measures
Measure	GTx-024 n=159 Participants subjects will be randomized to receive GTx-024 for the duration of the trail GTx-024: subjects will be randomized to receive GTx-024 for the duration of the trial.	Placebo n=161 Participants subjects will be randomized to receive placebo for the duration of the trial placebo: subject will receive placebo for the duration of the trial
Physical Function	19.5 percentage of subjects Interval 13.6 to 26.5	24.8 percentage of subjects Interval 18.4 to 32.3

PRIMARY outcome

Timeframe: Day 84

Population: Subjects included in the Full Analysis Set

Measure is the percentage of subjects at day 84 with lean body mass change \>=0% from their baseline value.

Outcome measures

Outcome measures
Measure	GTx-024 n=159 Participants subjects will be randomized to receive GTx-024 for the duration of the trail GTx-024: subjects will be randomized to receive GTx-024 for the duration of the trial.	Placebo n=161 Participants subjects will be randomized to receive placebo for the duration of the trial placebo: subject will receive placebo for the duration of the trial
Lean Body Mass	46.5 percentage of subjects Interval 38.6 to 54.6	37.9 percentage of subjects Interval 30.4 to 45.9

Adverse Events

GTx-024 3mg Once Daily

Serious events: 109 serious events

Other events: 149 other events

Deaths: 0 deaths

Placebo Once Daily

Serious events: 113 serious events

Other events: 157 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Senior Director, Clinical Operations

GTx Inc.

Phone: 1-901-261-3795

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Provide Sponsor with an advance copy of any proposed results communication at least 60 days prior to the date of the planned submission or presentation and Sponsor shall have 60 days from receipt to request any changes. Sponsor may request a delay of up to 60 additional days. The PI shall not present data until the earlier of Sponsor's publication of the results of all investigators participating in the Study or 18 months after completion of the Study at all participating sites.
Publication restrictions are in place

Restriction type: OTHER

Measure	GTx-024 3mg Once Daily n=165 participants at risk subjects will be randomized to receive GTx-024 for the duration of the trial GTx-024: subjects will be randomized to receive GTx-024 for the duration of the trial.	Placebo Once Daily n=165 participants at risk subjects will be randomized to receive placebo for the duration of the trial placebo: subject will receive placebo for the duration of the trial
Blood and lymphatic system disorders Anemia	50.9% 84/165 • Number of events 143 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	47.9% 79/165 • Number of events 119 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Blood and lymphatic system disorders Neutropenia	30.9% 51/165 • Number of events 92 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	33.9% 56/165 • Number of events 114 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Blood and lymphatic system disorders Thrombocytopenia	18.8% 31/165 • Number of events 45 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	17.6% 29/165 • Number of events 55 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Blood and lymphatic system disorders Leukopenia	15.8% 26/165 • Number of events 39 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	17.0% 28/165 • Number of events 52 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Gastrointestinal disorders Nausea	44.8% 74/165 • Number of events 153 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	44.2% 73/165 • Number of events 168 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Gastrointestinal disorders Vomiting	27.3% 45/165 • Number of events 81 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	29.1% 48/165 • Number of events 82 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Gastrointestinal disorders Constipation	12.7% 21/165 • Number of events 24 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	15.2% 25/165 • Number of events 33 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Gastrointestinal disorders Diarrhoea	9.1% 15/165 • Number of events 25 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	10.3% 17/165 • Number of events 23 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
General disorders Disease Progression	17.6% 29/165 • Number of events 34 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	18.8% 31/165 • Number of events 36 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
General disorders Fatigue	15.8% 26/165 • Number of events 37 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	17.6% 29/165 • Number of events 41 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
General disorders Asthenia	15.2% 25/165 • Number of events 30 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	16.4% 27/165 • Number of events 35 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
General disorders Pyrexia	11.5% 19/165 • Number of events 25 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	12.1% 20/165 • Number of events 29 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
General disorders Chest Pain	3.6% 6/165 • Number of events 8 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	7.3% 12/165 • Number of events 14 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
General disorders Oedema Peripheral	4.2% 7/165 • Number of events 8 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	6.1% 10/165 • Number of events 12 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Respiratory, thoracic and mediastinal disorders Cough	11.5% 19/165 • Number of events 21 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	9.1% 15/165 • Number of events 16 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.7% 21/165 • Number of events 23 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	6.7% 11/165 • Number of events 17 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Respiratory, thoracic and mediastinal disorders Haemoptysis	3.6% 6/165 • Number of events 6 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	6.7% 11/165 • Number of events 13 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Metabolism and nutrition disorders Decreased Appetite	19.4% 32/165 • Number of events 38 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	17.0% 28/165 • Number of events 37 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Metabolism and nutrition disorders Hypokalaemia	3.0% 5/165 • Number of events 5 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	7.3% 12/165 • Number of events 15 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Investigations Blood Creatinine Increased	13.9% 23/165 • Number of events 31 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	9.1% 15/165 • Number of events 22 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Nervous system disorders Dizziness	8.5% 14/165 • Number of events 18 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	9.7% 16/165 • Number of events 18 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Nervous system disorders Headache	8.5% 14/165 • Number of events 14 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	9.7% 16/165 • Number of events 20 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Infections and infestations Pneumonia	6.1% 10/165 • Number of events 11 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	6.1% 10/165 • Number of events 10 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Skin and subcutaneous tissue disorders Alopecia	10.9% 18/165 • Number of events 19 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	10.3% 17/165 • Number of events 19 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013
Musculoskeletal and connective tissue disorders Back Pain	4.2% 7/165 • Number of events 9 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013	6.1% 10/165 • Number of events 11 • 1 year, 6 months Initiation: 29 Nov 2011, Completion: 30 May 2013