A Study to Evaluate Biomarkers in Patients With Solid Tumors (0000-097)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00800865

First received: December 1, 2008

Last updated: August 23, 2011

Last verified: August 2011

History of Changes

Results First Received: January 12, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Diagnostic
Condition:	Tumors
Intervention:	Other: Biomarker sample collection before and after dosing with cytotoxic agent(s)

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
There were 36 participants enrolled. Of these, 4 from Group I and 1 from Group II did not have evaluable biopsies and were considered not evaluable. Data only reflect the evaluable population (15 from Group I and 16 from Group II).

Reporting Groups

	Description
Biomarker Evaluation Group I	Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
Biomarker Evaluation Group II	A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).

Participant Flow: Overall Study

	Biomarker Evaluation Group I	Biomarker Evaluation Group II
STARTED	15	16
COMPLETED	15	16
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Biomarker Evaluation Group I	Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
Biomarker Evaluation Group II	A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
Total	Total of all reporting groups

Baseline Measures

	Biomarker Evaluation Group I	Biomarker Evaluation Group II	Total
Number of Participants [units: participants]	15	16	31
Age, Customized [units: participants]
29-77 years	15	0	15
34-88 years	0	16	16
Gender [units: participants]
Female	5	7	12
Male	10	9	19

Outcome Measures

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1. Primary:

Level of Biomarkers [ Time Frame: Baseline, 24, 32, and 48 hours post dose ]

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2. Primary:

Ratio of pCDC2 Response in Skin Following Administration of Cytotoxic Therapy [ Time Frame: 24, 32, and 48 hours post dose ]

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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: This is an exploratory study to develop data for possible future studies. It is not intended to be published, unless important new information or data concerning the safety of a marketed product is obtained. The Sponsor must have the opportunity to review all abstracts, manuscripts, or presentations 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. Sponsor review can be expedited.

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
No text entered.

Results Point of Contact:

Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00800865 History of Changes
Other Study ID Numbers:	MK-0000-097, 2008_593
Study First Received:	December 1, 2008
Results First Received:	January 12, 2011
Last Updated:	August 23, 2011
Health Authority:	United States: Institutional Review Board

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