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Trial record 2 of 55 for:    hki-272 OR neratinib

Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT00300781
Recruitment Status : Completed
First Posted : March 9, 2006
Results First Posted : September 13, 2017
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Neoplasms
Neoplasms
Intervention Drug: neratinib
Enrollment 136
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neratinib 240, Prior Trastuzumab Neratinib 240, No Prior Trastuzumab
Hide Arm/Group Description Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen, in participants with prior trastuzumab treatment. Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with with no prior trastuzumab treatment.
Period Title: Overall Study
Started 66 70
Completed 3 8
Not Completed 63 62
Reason Not Completed
Disease Progression             55             52
Adverse Event             5             6
Withdrawal by Subject             1             2
Physician Decision             1             0
Not Recorded             0             1
Symptomatic Deterioration             1             0
Lost to Follow-up             0             1
Arm/Group Title Neratinib 240, Prior Trastuzumab Neratinib 240, No Prior Trastuzumab Total
Hide Arm/Group Description Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment. Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment. Total of all reporting groups
Overall Number of Baseline Participants 66 70 136
Hide Baseline Analysis Population Description
All treated subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 70 participants 136 participants
51.62  (10.67) 49.64  (9.92) 50.60  (10.30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 70 participants 136 participants
Female
66
 100.0%
70
 100.0%
136
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 70 participants 136 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
6
   9.1%
52
  74.3%
58
  42.6%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   3.0%
0
   0.0%
2
   1.5%
White
55
  83.3%
15
  21.4%
70
  51.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   4.5%
3
   4.3%
6
   4.4%
1.Primary Outcome
Title 16-week Progression Free Survival
Hide Description 16 week progression-free survival (PFS) rate of neratinib in women with human epidermal growth factor receptor 2 (HER2) positive breast cancer, either with prior trastuzumab or no prior trastuzumab therapy, evaluated by independent assessment of tumor scans collected at baseline and then every 8 weeks.
Time Frame From first dose to 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Neratinib 240, Prior Trastuzumab Neratinib 240, No Prior Trastuzumab
Hide Arm/Group Description:
Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.
Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.
Overall Number of Participants Analyzed 66 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
58.2
(45.3 to 71.2)
77.8
(67.6 to 88.1)
2.Secondary Outcome
Title Objective Response Rate
Hide Description Percentage of participants with Partial Response (PR) or Complete Response (CR) by independent assessment of tumor per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame From first dose date to progression or last tumor assessment, up to 46 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population
Arm/Group Title Neratinib 240, Prior Trastuzumab Neratinib 240, No Prior Trastuzumab
Hide Arm/Group Description:
Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.
Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.
Overall Number of Participants Analyzed 66 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
24.2
(14.5 to 36.4)
52.9
(40.6 to 64.9)
3.Secondary Outcome
Title Clinical Benefit Rate
Hide Description Percentage of participants who experienced Complete Response (CR), Partial Response (PR), or Stable Disease (SD) ≥ 24 weeks by independent assessment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions.
Time Frame From first dose date to progression or last tumor assessment, up to 46 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population
Arm/Group Title Neratinib 240, Prior Trastuzumab Neratinib 240, No Prior Trastuzumab
Hide Arm/Group Description:
Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.
Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.
Overall Number of Participants Analyzed 66 70
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
31.8
(20.9 to 44.4)
62.9
(50.5 to 74.1)
4.Secondary Outcome
Title Duration of Response
Hide Description Number of weeks between Complete Response (CR) or Partial Response (PR) and the first date of disease progression (PD) or death per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions
Time Frame From start date of response to first PD/death, up to 46 months
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects in Intent to Treat population with CR or PR
Arm/Group Title Neratinib 240, Prior Trastuzumab Neratinib 240, No Prior Trastuzumab
Hide Arm/Group Description:
Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment.
Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.
Overall Number of Participants Analyzed 16 37
Median (95% Confidence Interval)
Unit of Measure: weeks
40.3
(32.3 to 80.1)
60.0
(40.1 to 100.1)
Time Frame From first dose through 28 days after last dose, up to 46 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neratinib 240, Prior Trastuzumab Neratinib 240, No Prior Trastuzumab
Hide Arm/Group Description Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with prior trastuzumab treatment. Neratinib: 80mg capsules and 40mg coated tablets taken orally in prescribed dose of 240mg daily, as long as tolerated and disease does not worsen in participants with no prior trastuzumab treatment.
All-Cause Mortality
Neratinib 240, Prior Trastuzumab Neratinib 240, No Prior Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Neratinib 240, Prior Trastuzumab Neratinib 240, No Prior Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   19/66 (28.79%)   17/70 (24.29%) 
Blood and lymphatic system disorders     
Anaemia  1  0/66 (0.00%)  1/70 (1.43%) 
Cardiac disorders     
Atrioventricular block  1  0/66 (0.00%)  1/70 (1.43%) 
Bradycardia  1  0/66 (0.00%)  1/70 (1.43%) 
Gastrointestinal disorders     
Diarrhoea  1  4/66 (6.06%)  4/70 (5.71%) 
Nausea  1  2/66 (3.03%)  0/70 (0.00%) 
Vomiting  1  3/66 (4.55%)  6/70 (8.57%) 
General disorders     
Asthenia  1  0/66 (0.00%)  1/70 (1.43%) 
Fatigue  1  1/66 (1.52%)  0/70 (0.00%) 
Malaise  1  0/66 (0.00%)  1/70 (1.43%) 
Pyrexia  1  0/66 (0.00%)  1/70 (1.43%) 
Infections and infestations     
Disseminated tuberculosis  1  0/66 (0.00%)  1/70 (1.43%) 
Folliculitis  1  0/66 (0.00%)  1/70 (1.43%) 
Hepatitis E  1  0/66 (0.00%)  1/70 (1.43%) 
Mastitis  1  0/66 (0.00%)  1/70 (1.43%) 
Sinusitis  1  1/66 (1.52%)  0/70 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture  1  0/66 (0.00%)  1/70 (1.43%) 
Investigations     
Alanine aminotransferase increased  1  1/66 (1.52%)  1/70 (1.43%) 
Aspartate aminotransferase increased  1  1/66 (1.52%)  1/70 (1.43%) 
Blood creatinine increased  1  1/66 (1.52%)  1/70 (1.43%) 
Gamma-glutamyltransferase increased  1  1/66 (1.52%)  0/70 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite  1  2/66 (3.03%)  1/70 (1.43%) 
Dehydration  1  2/66 (3.03%)  4/70 (5.71%) 
Hyponatraemia  1  1/66 (1.52%)  0/70 (0.00%) 
Musculoskeletal and connective tissue disorders     
Muscular weakness  1  1/66 (1.52%)  0/70 (0.00%) 
Musculoskeletal pain  1  1/66 (1.52%)  0/70 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lymphangiosis carcinomatosa  1  1/66 (1.52%)  0/70 (0.00%) 
Malignant ascites  1  0/66 (0.00%)  1/70 (1.43%) 
Malignant pleural effusion  1  0/66 (0.00%)  1/70 (1.43%) 
Metastases to central nervous system  1  0/66 (0.00%)  1/70 (1.43%) 
Nervous system disorders     
Dyskinesia  1  1/66 (1.52%)  0/70 (0.00%) 
Headache  1  1/66 (1.52%)  0/70 (0.00%) 
Neuropathy peripheral  1  1/66 (1.52%)  0/70 (0.00%) 
VIIth nerve paralysis  1  1/66 (1.52%)  0/70 (0.00%) 
Psychiatric disorders     
Confusional state  1  1/66 (1.52%)  0/70 (0.00%) 
Renal and urinary disorders     
Nephrolithiasis  1  2/66 (3.03%)  0/70 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  2/66 (3.03%)  1/70 (1.43%) 
Hypoxia  1  1/66 (1.52%)  0/70 (0.00%) 
Pleural effusion  1  2/66 (3.03%)  1/70 (1.43%) 
Pulmonary embolism  1  0/66 (0.00%)  1/70 (1.43%) 
Vascular disorders     
Lymphoedema  1  1/66 (1.52%)  0/70 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Neratinib 240, Prior Trastuzumab Neratinib 240, No Prior Trastuzumab
Affected / at Risk (%) Affected / at Risk (%)
Total   66/66 (100.00%)   70/70 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  4/66 (6.06%)  8/70 (11.43%) 
Leukopenia  1  4/66 (6.06%)  2/70 (2.86%) 
Gastrointestinal disorders     
Abdominal discomfort  1  1/66 (1.52%)  5/70 (7.14%) 
Abdominal pain  1  19/66 (28.79%)  6/70 (8.57%) 
Abdominal pain upper  1  4/66 (6.06%)  1/70 (1.43%) 
Constipation  1  5/66 (7.58%)  2/70 (2.86%) 
Diarrhoea  1  63/66 (95.45%)  64/70 (91.43%) 
Dry mouth  1  4/66 (6.06%)  4/70 (5.71%) 
Dyspepsia  1  4/66 (6.06%)  7/70 (10.00%) 
Haemorrhoids  1  1/66 (1.52%)  4/70 (5.71%) 
Nausea  1  27/66 (40.91%)  23/70 (32.86%) 
Stomatitis  1  4/66 (6.06%)  4/70 (5.71%) 
Vomiting  1  16/66 (24.24%)  23/70 (32.86%) 
General disorders     
Asthenia  1  3/66 (4.55%)  10/70 (14.29%) 
Fatigue  1  26/66 (39.39%)  7/70 (10.00%) 
Oedema peripheral  1  4/66 (6.06%)  5/70 (7.14%) 
Pyrexia  1  5/66 (7.58%)  12/70 (17.14%) 
Infections and infestations     
Nasopharyngitis  1  2/66 (3.03%)  5/70 (7.14%) 
Paronychia  1  0/66 (0.00%)  6/70 (8.57%) 
Urinary tract infection  1  7/66 (10.61%)  1/70 (1.43%) 
Investigations     
Alanine aminotransferase increased  1  1/66 (1.52%)  5/70 (7.14%) 
Aspartate aminotransferase increased  1  1/66 (1.52%)  5/70 (7.14%) 
Weight decreased  1  3/66 (4.55%)  4/70 (5.71%) 
Metabolism and nutrition disorders     
Decreased appetite  1  15/66 (22.73%)  12/70 (17.14%) 
Dehydration  1  4/66 (6.06%)  3/70 (4.29%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/66 (10.61%)  7/70 (10.00%) 
Back pain  1  5/66 (7.58%)  8/70 (11.43%) 
Muscle spasms  1  4/66 (6.06%)  2/70 (2.86%) 
Musculoskeletal chest pain  1  4/66 (6.06%)  3/70 (4.29%) 
Musculoskeletal pain  1  5/66 (7.58%)  3/70 (4.29%) 
Pain in extremity  1  5/66 (7.58%)  7/70 (10.00%) 
Nervous system disorders     
Dizziness  1  5/66 (7.58%)  6/70 (8.57%) 
Dysgeusia  1  6/66 (9.09%)  0/70 (0.00%) 
Headache  1  12/66 (18.18%)  14/70 (20.00%) 
Psychiatric disorders     
Insomnia  1  3/66 (4.55%)  4/70 (5.71%) 
Renal and urinary disorders     
Dysuria  1  1/66 (1.52%)  6/70 (8.57%) 
Pollakiuria  1  4/66 (6.06%)  1/70 (1.43%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/66 (12.12%)  6/70 (8.57%) 
Dyspnoea  1  8/66 (12.12%)  4/70 (5.71%) 
Epistaxis  1  1/66 (1.52%)  5/70 (7.14%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  3/66 (4.55%)  4/70 (5.71%) 
Dermatitis acneiform  1  2/66 (3.03%)  9/70 (12.86%) 
Dry skin  1  4/66 (6.06%)  3/70 (4.29%) 
Nail disorder  1  5/66 (7.58%)  0/70 (0.00%) 
Pruritus  1  8/66 (12.12%)  4/70 (5.71%) 
Rash  1  14/66 (21.21%)  9/70 (12.86%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
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.
Results Point of Contact
Name/Title: Senior Director, Clinical Operations
Organization: Puma Biotechnology, Inc.
Phone: +1 (424) 248-6500
Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00300781     History of Changes
Other Study ID Numbers: 3144A1-201 / B1891012
First Submitted: March 7, 2006
First Posted: March 9, 2006
Results First Submitted: August 10, 2017
Results First Posted: September 13, 2017
Last Update Posted: August 14, 2018