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Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer

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ClinicalTrials.gov Identifier: NCT00558103
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : July 18, 2012
Last Update Posted : February 4, 2013
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Neoplasms, Breast
Interventions: Drug: lapatinib
Drug: Pazopanib

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study consisted of an initial randomized treatment phase; participants were randomized to receive lapatinib, pazopanib, or combination therapy. Participants who received pazopanib monotherapy in this initial phase and experienced disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Enrollment in Cohort 1 was halted after 76 participants had been randomized based on safety data from Study VEG20007 (NCT00347919). The protocol was amended (Amendment 2) to change the combination therapy dose (Cohort 2); in addition, an open-label pazopanib arm (pazopanib 800 milligrams) was added (Cohort 2).

Reporting Groups
  Description
Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
Cohort 2: Pazopanib 800 mg Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
Open-label Lapatinib 1500 mg Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.

Participant Flow for 2 periods

Period 1:   Randomized Treatment Phase
    Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo   Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg   Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo   Cohort 2: Pazopanib 800 mg   Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg   Open-label Lapatinib 1500 mg
STARTED   38   38   36   13   38   0 
COMPLETED   33   34   33   11   33   0 
NOT COMPLETED   5   4   3   2   5   0 
Lost to Follow-up                2                2                2                1                3                0 
Withdrawal by Subject                2                2                0                0                1                0 
Disease Progression                1                0                1                0                0                0 
Adverse Event                0                0                0                1                1                0 

Period 2:   Monotherapy Extension Phase
    Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo   Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg   Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo   Cohort 2: Pazopanib 800 mg   Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg   Open-label Lapatinib 1500 mg
STARTED   0   0   0   0   0   9 [1] 
COMPLETED   0   0   0   0   0   0 
NOT COMPLETED   0   0   0   0   0   9 
Protocol Violation                0                0                0                0                0                1 
Disease Progression                0                0                0                0                0                8 
[1] 9/11 participants completing pazopanib monotherapy elected to receive lapatinib monotherapy.



  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
Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
Cohort 2: Pazopanib 800 mg Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
Total Total of all reporting groups

Baseline Measures
   Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo   Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg   Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo   Cohort 2: Pazopanib 800 mg   Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 38   38   36   13   38   163 
Age 
[Units: Years]
Mean (Standard Deviation)
           
Years   51.9  (9.00)   52.4  (12.84)   53.0  (10.39)   54.7  (12.26)   53.9  (12.65)   53.0  (11.31) 
Gender 
[Units: Participants]
           
Female   38   38   36   13   38   163 
Male   0   0   0   0   0   0 
Race/Ethnicity, Customized 
[Units: Participants]
           
African American/African Heritage   1   1   0   0   0   2 
American Indian or Alaska Native   1   3   2   1   3   10 
Central/South Asian Heritage   2   1   2   1   2   8 
Japanese/East Asian /South East Asian Heritage   9   6   11   5   14   45 
White   24   27   21   6   19   97 
American Indian or Alaska Native and Asian   1   0   0   0   0   1 


  Outcome Measures

1.  Primary:   Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions   [ Time Frame: Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks ]

2.  Secondary:   Median Duration of Response,Defined as the First Documented Evidence of CR or PR Until the First Documentation of Disease Progression   [ Time Frame: From the date of the first documented evidence of CR or PR until the date of the first documented disease progression or death, assessed for up to 62 weeks ]

3.  Secondary:   Progression-free Survival, Defined as the Interval Between the Date of Randomization and the Earliest Date of Disease Progression (PD) or Death Due to Any Cause (Defined by an Investigator Review of Lesions Based on RECIST and Cutaneous Disease)   [ Time Frame: From the date of the randomization until the earliest date of disease progression or death due to any cause, assessed for up to 66 weeks ]

4.  Secondary:   Overall Survival   [ Time Frame: From the date of randomization until the date of death due to any cause, assessed for up to 163 weeks ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00558103     History of Changes
Other Study ID Numbers: VEG108838
First Submitted: November 9, 2007
First Posted: November 14, 2007
Results First Submitted: May 17, 2012
Results First Posted: July 18, 2012
Last Update Posted: February 4, 2013