Randomized Discontinuation Study of Lapatinib Versus Placebo in Subjects With Documented Tumor Progression After Chemotherapy, or Where no Approved Therapy Exists

This study has been terminated.
(The study had failed to meet the primary objective of tumor response rate at 12 weeks from first dose.)
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00447226
First received: March 13, 2007
Last updated: June 7, 2012
Last verified: June 2012
Results First Received: January 11, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Cancer
Intervention: Drug: Oral lapatinib tablets or placebo tablets

  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
Participants maintaining stable disease (SD) in Stage 1 (open label) were randomized to double-blind lapatinib 1500 milligrams (mg)/day or placebo (Stage 2). Of 32 participants in Stage 1, 7 maintained SD and were randomized into Stage 2. These 7 participants are represented as "completed" in the "Open-label Phase" participant flow table.

Reporting Groups
  Description
Placebo Identical matching placebo orally, once a day
Lapatinib 1500 Milligrams (mg) Lapatinib 1500 mg orally, once a day

Participant Flow for 2 periods

Period 1:   12-Week Open-label Phase
    Placebo     Lapatinib 1500 Milligrams (mg)  
STARTED     0     32  
COMPLETED     0     7  
NOT COMPLETED     0     25  
Adverse Event                 0                 3  
Protocol Violation                 0                 1  
Disease Progression                 0                 20  
Physician Decision                 0                 1  

Period 2:   Double-blind Phase
    Placebo     Lapatinib 1500 Milligrams (mg)  
STARTED     4     3  
COMPLETED     0     0  
NOT COMPLETED     4     3  
Disease Progression                 4                 3  



  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
All Participants All participants treated in the open-label phase (1500 milligrams [mg] lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  32  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 10.25  
Gender  
[units: participants]
 
Female     13  
Male     19  
Race/Ethnicity, Customized  
[units: participants]
 
White     31  
African American/ African heritage     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With the Indicated Tumor Response at 12 Weeks From First Dose   [ Time Frame: Week 12 ]

2.  Primary:   Percentage of Participants Who Remained Progression-free 12 Weeks After Randomization   [ Time Frame: Week 12 after randomization. ]

3.  Secondary:   Duration of Response   [ Time Frame: (assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib) ]

4.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From start of treatment to disease progression/death (assessments every 12 weeks until death for withdrawn participants and every 3 weeks for participants continuing on lapatinib) ]

5.  Secondary:   Time to Disease Progression (TTP)   [ Time Frame: From start of treatment to disease progression/death (up to 83.3 weeks) ]

6.  Secondary:   Number of Participants With the Indicated Change in Cancer Antigen-125 (CA-125) Levels From Day 1   [ Time Frame: Pre-dose and every 6 weeks until withdrawal (up to 84.1 weeks) ]

7.  Secondary:   Incidence of MET Amplification in Gastric Cancer   [ Time Frame: Performed on archived tissue collected at screening. ]

8.  Secondary:   Incidence of ErbB2-positive Participants   [ Time Frame: Screening ]


  Serious Adverse Events


  Other Adverse Events


  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 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.


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
Study terminated prematurely: preliminary assessment (prompted by low screening/enrollment rates) showed primary objective of tumor response rate not met. Also unable to test primary treatment comparison after randomization following SD at 12 wks.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00447226     History of Changes
Other Study ID Numbers: LPT108741
Study First Received: March 13, 2007
Results First Received: January 11, 2010
Last Updated: June 7, 2012
Health Authority: United States: Food and Drug Administration