Intravenous Weekly Topotecan In Subjects With Recurrent Or Persistent Endometrial Cancer

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00267488

First received: December 20, 2005

Last updated: June 28, 2012

Last verified: June 2012

History of Changes

Results First Received: December 5, 2008

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Neoplasms, Endometrial Endometrial Cancer
Intervention:	Drug: topotecan

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
Topotecan Hydrochloride	Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.

Participant Flow: Overall Study

	Topotecan Hydrochloride
STARTED	37
COMPLETED	26
NOT COMPLETED	11
Sponsor Terminated Study	9
Protocol Violation	1
Other (Disease Progression)	1

Baseline Characteristics

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Outcome Measures

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1. Primary:

Best Overall Response [ Time Frame: Week 0 to Week 98 when endpoints were met ]

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2. Secondary:

Time to Progression [ Time Frame: Week 0 to Week 19 when endpoints were met ]

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3. Secondary:

Overall Survival [ Time Frame: Week 0 to Week 98 ]

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4. Secondary:

Response Duration [ Time Frame: Week 0 to week 98 ]

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5. Secondary:

Time to Response [ Time Frame: Week 0 to week 98 ]

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6. Secondary:

Safety and Tolerability as Summarized Through Adverse Event Reporting [ Time Frame: Week 0 to week 98 ]

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Serious Adverse Events

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Other Adverse Events

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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: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

Limitations and Caveats

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
As there was only 1 responder, time to response, and duration of response were not calculated.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00267488 History of Changes
Other Study ID Numbers:	100414
Study First Received:	December 20, 2005
Results First Received:	December 5, 2008
Last Updated:	June 28, 2012
Health Authority:	Hungary: National Institute of Pharmacy Canada: Canadian Institutes of Health Research United States: Food and Drug Administration

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