Clinical Trial of MK0683 in Combination With FDA Approved Cancer Drugs in Patients With Advanced NSCLC (MK0683-058)

This study has been completed.

Study NCT00423449 Information provided by Merck

First Received on January 17, 2007. Last Updated on July 6, 2011 History of Changes

Results First Received: July 6, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Non-Small Cell Lung Cancer
Interventions:	Drug: vorinostat Drug: Gemcitabine Drug: Platinum-based agent

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
Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin	Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin	Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin	Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin	Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin	Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.

Participant Flow: Overall Study

	Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin	Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin	Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin	Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin	Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin
STARTED	4	6	17	27	7
COMPLETED	1	2	2	5	0
NOT COMPLETED	3	4	15	22	7
Clinical Adverse Event	1	0	1	8	2
Death	1	0	2	1	1
Progressive Disease	1	3	8	11	4
Laboratory Adverse Event	0	1	2	0	0
Not Specified	0	0	0	1	0
Protocol Violation	0	0	2	1	0

Baseline Characteristics

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Reporting Groups

	Description
All Participants	Vorinostat + Gemcitabine + Cisplatin

Baseline Measures

	All Participants
Number of Participants [units: participants]	61
Age [units: years] Mean ± Standard Deviation	56.7 ± 9.2
Gender [units: participants]
Female	17
Male	44

Outcome Measures

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1. Primary:

Number of Participants With Dose-limiting Toxicities (DLT) Due to Vorinostat Administered in Combination With Standard Dose of Gemcitabine Plus Either Cisplatin or Carboplatin [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ]

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2. Primary:

Maximum Tolerated Dose of Vorinostat Administered in Combination With Standard Doses of Gemcitabine Plus Either Cisplatin or Carboplatin in Patients With Advanced Stage Non-Small Cell Lung Cancer Who Have Not Received Chemotherapy for Advanced Disease [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ]

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3. Secondary:

Number of Participants With Clinical Adverse Experiences (Safety and Tolerability) [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ]

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4. Secondary:

Number of Participants With Laboratory Adverse Experiences (Safety and Tolerability) [ Time Frame: every 21 days (every cycle), up to 126 days (6 cycles) ]

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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: The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 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 to meet publication guidelines.

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
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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@merck.com

No publications provided

Responsible Party:	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier:	NCT00423449 History of Changes
Other Study ID Numbers:	MK-0683-058, 2006_528
Study First Received:	January 17, 2007
Results First Received:	July 6, 2011
Last Updated:	July 6, 2011
Health Authority:	France: Ministry of Health