A Study Of Oral GW572016 In Advanced Or Metastatic Non-Small Cell Lung Cancer

This study has been terminated.

( Based on interim analysis at the end of Stage 1, and predefined stopping rules for futility, further enrollment was stopped due to lack of efficacy )

Study NCT00073008 Information provided by GlaxoSmithKline

First Received on November 13, 2003. Last Updated on March 17, 2011 History of Changes

Results First Received: June 15, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Non-Small-Cell Lung Cancer Lung Cancer, Non-Small Cell
Intervention:	Drug: GW572016 (lapatinib)

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
Lapatinib 1500 mg QD	Oral lapatinib 1500 mg once daily (QD)
Lapatinib 500 mg BID	Oral lapatinib 500 mg twice daily (BID)

Participant Flow: Overall Study

	Lapatinib 1500 mg QD	Lapatinib 500 mg BID
STARTED	65	66
COMPLETED	3	3
NOT COMPLETED	62	63
Missing	6	6
Withdrawal by Subject	2	2
Lost to Follow-up	1	3
Death	46	47
"Other" selected on Case Report Form	7	5

Baseline Characteristics

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Reporting Groups

	Description
Lapatinib 1500 mg QD	Oral lapatinib 1500 mg once daily (QD)
Lapatinib 500 mg BID	Oral lapatinib 500 mg twice daily (BID)

Baseline Measures

	Lapatinib 1500 mg QD	Lapatinib 500 mg BID	Total
Number of Participants [units: participants]	65	66	131
Age [units: years] Mean ± Standard Deviation	65.1 ± 12.03	65.2 ± 10.56	65.1 ± 11.27
Gender [units: participants]
Female	33	40	73
Male	32	26	58
Race/Ethnicity, Customized [units: participants]
White	54	56	110
Black	4	1	5
Asian	4	5	9
American Hispanic	2	4	6
Other	1	0	1
Histology at diagnosis ^[1] [units: Participants]
Squamous cell	9	3	12
Bronchioloalveolar carcinoma (BAC)	3	2	5
Adenocarcinoma with BAC features	8	13	21
Adenocarcinoma without BAC features	34	43	77
Other non-small cell lung cancer type	5	1	6
Other	4	2	6
Missing	2	2	4

[1]	Type of lung cancer

Outcome Measures

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1. Primary:

Tumor Response in the Targeted Population Through the End of Treatment [ Time Frame: Baseline and then every 8 weeks through end of treatment ]

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2. Secondary:

Progression-free Survival (PFS) at Four Months in the Targeted Population [ Time Frame: From randomization and then every 8 weeks up to four months ]

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3. Secondary:

Progression-free Survival (PFS) at Four Months in the Non-Targeted Population [ Time Frame: From randomization and then every 8 weeks up to four months ]

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4. Secondary:

The Number of Participants Who Showed Certain Biomarkers in Their Serum or Tumor Tissue [ Time Frame: From randomization to disease progression (for serum biomarkers) or until analyses of tumor tissue samples ]

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5. Secondary:

Pharmacokinetics (PK) of Lapatinib [ Time Frame: From randomization to time of PK period completed: Day 1 (first dose) and Days 2, 28, and 29 while participant was on study drug ]

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6. Secondary:

Pharmacogenetics (PgX) [ Time Frame: From randomization at every 4-week assessment through end of treatment ]

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7. Secondary:

Quality of Life [ Time Frame: Baseline and then every 4 weeks through end of treatment ]

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8. Secondary:

Time to Response [ Time Frame: From randomization and then every 8 weeks to time of response to study drug ]

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9. Secondary:

Duration of Response [ Time Frame: Time from first documented evidence of response to study treatment and then every 8 weeks until disease progression or death ]

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10. Secondary:

Time to Tumor Progression [ Time Frame: From randomization and then every 8 weeks to disease progression or death ]

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11. Secondary:

Overall Survival [ Time Frame: From randomization and then every 8 weeks while on study drug and then every 3 months as follow-up until death ]

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12. Secondary:

Review of Non-small Cell Lung Cancer (NSCLC) Histology (Cell Type) Using an Independent Review [ Time Frame: Anytime from Baseline through end of study ]

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13. Other Pre-specified:

Tumor Response in the Non-Targeted Population Through the End of Treatment [ Time Frame: Baseline and then every 8 weeks through end of treatment ]

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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
Based on interim analysis and predefined stopping rules for futility, the study was discontinued due to lack of efficacy. At that time, no additional participants were added; enrolled participants could continue on treatment, following the protocol.

Results Point of Contact:

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

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00073008 History of Changes
Obsolete Identifiers:	NCT00084955
Other Study ID Numbers:	EGF20014
Study First Received:	November 13, 2003
Results First Received:	June 15, 2009
Last Updated:	March 17, 2011
Health Authority:	United States: Food and Drug Administration