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Study Evaluating HKI-272 in Tumors

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ClinicalTrials.gov Identifier: NCT00146172
Recruitment Status : Completed
First Posted : September 5, 2005
Results First Posted : February 13, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Neoplasms
Intervention: Drug: neratinib

  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
Neratinib 40 mg Neratinb 40 mg qd
Neratinib 80 mg Neratinib 80 mg qd
Neratinib 120 mg Neratinib 120 mg qd
Neratinib 180 mg Neratinib 180 mg qd
Neratinib 240 mg Neratinib 240 mg qd
Neratinib 320 mg Neratinib 320 mg qd
Neratinib 400 mg Neratinib 400 mg qd
Neratinib MTD Neratinib maximum tolerated dose (320 mg).

Participant Flow:   Overall Study
    Neratinib 40 mg   Neratinib 80 mg   Neratinib 120 mg   Neratinib 180 mg   Neratinib 240 mg   Neratinib 320 mg   Neratinib 400 mg   Neratinib MTD
STARTED   3   4   4   6   3   7   6   40 
Received Drug   3   4   4   6   3   7   6   39 
COMPLETED   0   0   0   0   0   0   0   0 
NOT COMPLETED   3   4   4   6   3   7   6   40 
Adverse Event                0                0                1                1                0                2                3                10 
Lost to Follow-up                0                0                0                0                0                0                0                1 
Disease Progression                2                4                2                5                2                2                1                22 
Death                0                0                0                0                0                0                1                0 
Physician Decision                0                0                0                0                0                0                0                1 
Withdrawal by Subject                0                0                0                0                0                1                1                4 
Symptomatic Deterioration                1                0                1                0                1                2                0                2 



  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
Neratinib 40 mg Neratinb 40 mg qd
Neratinib 80 mg Neratinib 80 mg qd
Neratinib 120 mg Neratinib 120 mg qd
Neratinib 180 mg Neratinib 180 mg qd
Neratinib 240 mg Neratinib 240 mg qd
Neratinib 320 mg Neratinib 320 mg qd
Neratinib 400 mg Neratinib 400 mg qd
Neratinib MTD Neratinib maximum tolerated dose (320 mg) from part 2.
Total Total of all reporting groups

Baseline Measures
   Neratinib 40 mg   Neratinib 80 mg   Neratinib 120 mg   Neratinib 180 mg   Neratinib 240 mg   Neratinib 320 mg   Neratinib 400 mg   Neratinib MTD   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   4   4   6   3   7   6   39   72 
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%      0   0.0% 
Between 18 and 65 years      3 100.0%      4 100.0%      2  50.0%      5  83.3%      3 100.0%      3  42.9%      6 100.0%      28  71.8%      54  75.0% 
>=65 years      0   0.0%      0   0.0%      2  50.0%      1  16.7%      0   0.0%      4  57.1%      0   0.0%      11  28.2%      18  25.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.33  (12.50)   54.00  (7.66)   56.25  (20.43)   60.67  (15.31)   57.00  (8.89)   63.71  (15.70)   51.33  (8.91)   58.18  (11.05)   57.68  (12.06) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
                 
Female      2  66.7%      4 100.0%      3  75.0%      6 100.0%      2  66.7%      5  71.4%      4  66.7%      26  66.7%      52  72.2% 
Male      1  33.3%      0   0.0%      1  25.0%      0   0.0%      1  33.3%      2  28.6%      2  33.3%      13  33.3%      20  27.8% 


  Outcome Measures

1.  Primary:   Dose Limiting Toxicity (DLT)   [ Time Frame: From first dose date to day 14 ]

2.  Primary:   Maximum Tolerated Dose (MTD)   [ Time Frame: From first dose date to day 14 ]

3.  Secondary:   Number of Participants With Best Overall Response   [ Time Frame: From first dose date to progression or last tumor assessment, up to 39 weeks. ]

4.  Secondary:   Duration of Response   [ Time Frame: From start date of response to first PD, up to 39 weeks. ]

5.  Secondary:   Progression Free Survival   [ Time Frame: From first dose date to progression or death, up to 39 weeks. ]

6.  Secondary:   Objective Response Rate   [ Time Frame: From first dose date to progression/death or last assessment, up to 39 weeks ]

7.  Secondary:   Clinical Benefit Rate   [ Time Frame: From first dose date to progression/death or last assessment, up to 39 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 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



Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00146172     History of Changes
Other Study ID Numbers: 3144A1-102
First Submitted: September 2, 2005
First Posted: September 5, 2005
Results First Submitted: August 10, 2017
Results First Posted: February 13, 2018
Last Update Posted: September 17, 2018