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Lapatinib in Treating Patients With Locally Advanced or Metastatic Biliary Tract or Liver Cancer That Cannot Be Removed By Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00101036
First received: January 7, 2005
Last updated: December 18, 2014
Last verified: October 2013
Results First Received: July 21, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer
Recurrent Extrahepatic Bile Duct Cancer
Recurrent Gallbladder Cancer
Unresectable Extrahepatic Bile Duct Cancer
Unresectable Gallbladder Cancer
Interventions: Drug: lapatinib ditosylate
Other: laboratory biomarker analysis

  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
No text entered.

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
Arm 1 GW572016 1500 mg orally daily for 28 days, Biliary strata
Arm 2 GW572016 1500 mg orally daily for 28 days, HCC strata

Participant Flow:   Overall Study
    Arm 1     Arm 2  
STARTED     17     40  
COMPLETED     17     40  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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
Arm 1 GW572016 1500 mg orally daily for 28 days, Biliary strata
Arm 2 GW572016 1500 mg orally daily for 28 days, HCC strata
Total Total of all reporting groups

Baseline Measures
    Arm 1     Arm 2     Total  
Number of Participants  
[units: participants]
  17     40     57  
Age  
[units: years]
Median (Full Range)
  58  
  (44 to 76)  
  62  
  (19 to 82)  
  62  
  (19 to 82)  
Gender  
[units: participants]
     
Female     13     8     21  
Male     4     32     36  
Region of Enrollment  
[units: participants]
     
United States     17     40     57  



  Outcome Measures
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1.  Primary:   Response Rate   [ Time Frame: Up to 5 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 5 years ]

3.  Secondary:   Progress-free Survival   [ Time Frame: Up to 5 years ]

4.  Secondary:   Disease Control Rate (i.e., the Mathematical Sum of Percentages of Complete Response, Partial Response and Stable Disease)   [ Time Frame: Up to 5 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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:
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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: DCC Project Administrator
Organization: California Cancer Consortium
phone: 626-256-4673 ext 60094
e-mail: CCCP@coh.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00101036     History of Changes
Other Study ID Numbers: NCI-2012-03065
NCI-2012-03065 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
PHII-53 ( Other Identifier: UC Davis Comprehensive Cancer Center )
6674 ( Other Identifier: CTEP )
N01CM62201 ( US NIH Grant/Contract Award Number )
N01CM62209 ( US NIH Grant/Contract Award Number )
Study First Received: January 7, 2005
Results First Received: July 21, 2014
Last Updated: December 18, 2014
Health Authority: United States: Food and Drug Administration