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)
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00073008
First received: November 13, 2003
Last updated: March 17, 2011
Last verified: March 2011
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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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
  Hide Baseline Characteristics

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.
No text entered.

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)
Total Total of all reporting groups

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
  Show All Outcome Measures

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 ]

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 ]

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 ]

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 ]

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 ]

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

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

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

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 ]

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

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 ]

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 ]

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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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:
unchecked 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.
unchecked 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.


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