Gossypol Acetic Acid in Treating Patients With Recurrent, Metastatic, or Primary Adrenocortical Cancer That Cannot Be Removed By Surgery

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Cancer Institute (NCI)

ClinicalTrials.gov Identifier:

NCT00848016

First received: February 19, 2009

Last updated: April 17, 2014

Last verified: January 2014

History of Changes

Results First Received: January 6, 2014

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Recurrent Adrenocortical Carcinoma Stage III Adrenocortical Carcinoma Stage IV Adrenocortical Carcinoma
Intervention:	Drug: R-(-)-gossypol acetic acid

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
This study opened on 3/17/2009 and accrued 29 participants before being permanently closed 8/03/2011.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All 29 participants are off treatment, and all participants are evaluable for response and for adverse responses.

Reporting Groups

	Description
Treatment (R-(-)-Gossypol Acetic Acid)	Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Participant Flow: Overall Study

	Treatment (R-(-)-Gossypol Acetic Acid)
STARTED	29
COMPLETED	29
NOT COMPLETED	0

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.
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Reporting Groups

	Description
Treatment (R-(-)-Gossypol Acetic Acid)	Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Baseline Measures

	Treatment (R-(-)-Gossypol Acetic Acid)
Number of Participants [units: participants]	29
Age [units: years] Median (Full Range)	50 (28 to 76)
Gender [units: participants]
Female	15
Male	14
Region of Enrollment [units: participants]
United States	29

Outcome Measures

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1. Primary:

The Proportion of Patients Who Achieve a Confirmed Objective Response to Treatment, Either Partial Response (PR) or Complete Response (CR) as Defined by Response Evaluation Criteria In Solid Tumors (RECIST) Criteria [ Time Frame: Up to 2 years ]

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2. Secondary:

Overall Survival [ Time Frame: From registration to date of last follow-up or death due to any cause, assessed up to 2 years ]

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3. Secondary:

Progression-free Survival [ Time Frame: From registration to progression or death, whichever occurs first, up to 2 years. ]

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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.

Results Point of Contact:

Name/Title: Michael E. Menefee, M.D.
Organization: Mayo Clinic Cancer Center
e-mail: menefee.michael@mayo.edu

Responsible Party:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00848016 History of Changes
Other Study ID Numbers:	NCI-2009-01160 MC0771 8035 CDR0000635024 N01CM00070 ( US NIH Grant/Contract Award Number ) N01CM00038 ( US NIH Grant/Contract Award Number )
Study First Received:	February 19, 2009
Results First Received:	January 6, 2014
Last Updated:	April 17, 2014
Health Authority:	United States: Food and Drug Administration

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