Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GTx

ClinicalTrials.gov Identifier:

NCT01355484

First received: May 12, 2011

Last updated: February 4, 2016

Last verified: February 2016

History of Changes

Results First Received: February 4, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Conditions:	Muscle Wasting Non Small Cell Lung Cancer
Interventions:	Drug: GTx-024 Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
GTx-024	subject will receive GTx-024 treatment for the duration of the trial GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.
Placebo	subject will receive placebo for the duration of the trial placebo: subject will receive placebo for the duration of the trial

Description

GTx-024

subject will receive GTx-024 treatment for the duration of the trial

GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.

Placebo

subject will receive placebo for the duration of the trial

placebo: subject will receive placebo for the duration of the trial

Participant Flow: Overall Study

	GTx-024	Placebo
STARTED	160	161
COMPLETED	109	107
NOT COMPLETED	51	54

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects included in the Full Analysis Set

Reporting Groups

	Description
GTx-024	subject will receive GTx-024 treatment for the duration of the trial GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.
Placebo	subject will receive placebo for the duration of the trial placebo: subject will receive placebo for the duration of the trial
Total	Total of all reporting groups

Description

GTx-024

subject will receive GTx-024 treatment for the duration of the trial

GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.

Placebo

subject will receive placebo for the duration of the trial

placebo: subject will receive placebo for the duration of the trial

Total

Total of all reporting groups

Baseline Measures

	GTx-024	Placebo	Total
Number of Participants [units: participants]	160	161	321
Age [units: years] Median (Full Range)	60.5 (36 to 84)	62.0 (34 to 88)	61.0 (34 to 88)
Gender [units: participants]
Female	43	46	89
Male	117	115	232

Outcome Measures

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1. Primary:

Physical Function [ Time Frame: Day 84 ]

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2. Primary:

Lean Body Mass [ Time Frame: Day 84 ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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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 agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:

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.

Results Point of Contact:

Name/Title: Senior Director, Clinical Operations
Organization: GTx Inc.
phone: 1-901-261-3795
e-mail: mdesordi@gtxinc.com

Responsible Party:	GTx
ClinicalTrials.gov Identifier:	NCT01355484 History of Changes
Other Study ID Numbers:	G300504 POWER1 ( Other Identifier: GTx )
Study First Received:	May 12, 2011
Results First Received:	February 4, 2016
Last Updated:	February 4, 2016
Health Authority:	United States: Food and Drug Administration Ukraine: Ministry of Health Poland: Ethics Committee Russia: Ministry of Health of the Russian Federation Hungary: Research Ethics Medical Committee Chile: Ministry of Health Peru: Ministry of Health Argentina: Ministry of Health

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