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Study Evaluating The Combination Of Neratinib And Capecitabine In Solid Tumors And Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00741260
First Posted: August 26, 2008
Last Update Posted: November 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
Results First Submitted: August 10, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Neratinib
Drug: Capecitabine

  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
N160 + C1500 Neratinib 160 mg + Capecitabine 1500 mg/sq m
N240 + C1500 Neratinib 240 mg + Capecitabine 1500 mg/sq m
N240 + C2000 Neratinib 240 mg + Capecitabine 2000 mg/sq m
N200 + C2000 Neratinib 200 mg + Capecitabine 2000 mg/sq m
N160 + C2000 Neratinib 160 mg + Capecitabine 2000 mg/sq m
N + C MTD - No Prior Lap Neratinib + Capecitabine MTD (No prior Lapatinib)
N + C MTD - Prior Lap Neratinib + Capecitabine MTD (Prior Lapatinib)

Participant Flow:   Overall Study
    N160 + C1500   N240 + C1500   N240 + C2000   N200 + C2000   N160 + C2000   N + C MTD - No Prior Lap   N + C MTD - Prior Lap
STARTED   6   8   4   6   9   65   7 
COMPLETED   0   0   0   0   0   20   0 
NOT COMPLETED   6   8   4   6   9   45   7 
Disease Progression                3                5                3                3                5                37                4 
Death                0                1                0                1                2                2                1 
Withdrawal by Subject                0                0                0                0                1                3                1 
Physician Decision                1                1                0                0                0                0                0 
Not Specified                2                1                1                2                1                3                1 



  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.
Safety population

Reporting Groups
  Description
N160 + C1500 Neratinib 160 mg + Capecitabine 1500 mg/sq m
N240 + C1500 Neratinib 240 mg + Capecitabine 1500 mg/sq m
N240 + C2000 Neratinib 240 mg + Capecitabine 2000 mg/sq m
N200 + C2000 Neratinib 200 mg + Capecitabine 2000 mg/sq m
N160 + C2000 Neratinib 160 mg + Capecitabine 2000 mg/sq m
N + C MTD - No Prior Lap Neratinib + Capecitabine MTD (No prior Lapatinib)
N + C MTD - Prior Lap Neratinib + Capecitabine MTD (Prior Lapatinib)
Total Total of all reporting groups

Baseline Measures
   N160 + C1500   N240 + C1500   N240 + C2000   N200 + C2000   N160 + C2000   N + C MTD - No Prior Lap   N + C MTD - Prior Lap   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   8   4   6   9   65   7   105 
Age 
[Units: Participants]
Count of Participants
               
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      5  83.3%      7  87.5%      3  75.0%      3  50.0%      7  77.8%      59  90.8%      7 100.0%      91  86.7% 
>=65 years      1  16.7%      1  12.5%      1  25.0%      3  50.0%      2  22.2%      6   9.2%      0   0.0%      14  13.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.7  (11.50)   53.3  (10.42)   56.3  (17.15)   59.0  (10.88)   55.7  (10.64)   51.5  (10.48)   50.9  (10.65)   52.4  (10.77) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
               
Female      4  66.7%      5  62.5%      3  75.0%      3  50.0%      6  66.7%      65 100.0%      7 100.0%      93  88.6% 
Male      2  33.3%      3  37.5%      1  25.0%      3  50.0%      3  33.3%      0   0.0%      0   0.0%      12  11.4% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
               
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      25  38.5%      3  42.9%      28  26.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  16.7%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      2   3.1%      0   0.0%      3   2.9% 
White      5  83.3%      8 100.0%      4 100.0%      6 100.0%      9 100.0%      38  58.5%      4  57.1%      74  70.5% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Dose Limiting Toxicities   [ Time Frame: From first dose date to 21st day or to time receiving 75% of planned doses ]

2.  Secondary:   Overall Response Rate   [ Time Frame: From first dose date to progression or last tumor assessment, up to three years. ]

3.  Secondary:   Clinical Benefit Rate   [ Time Frame: From first dose date to progression or last tumor assessment, up to three years. ]

4.  Secondary:   Duration of Response   [ Time Frame: From start date of response to first PD/death, up to three years. ]


  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: Senior Director, Clinical Operations
Organization: Puma Biotechnology, Inc.
phone: +1 (424) 248-6500
e-mail: clinicaltrials@pumabiotechnology.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00741260     History of Changes
Other Study ID Numbers: 3144A1-2206
B1891017
First Submitted: August 22, 2008
First Posted: August 26, 2008
Results First Submitted: August 10, 2017
Results First Posted: November 9, 2017
Last Update Posted: November 9, 2017