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Trial record 10 of 55 for:    hki-272 OR neratinib

A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

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ClinicalTrials.gov Identifier: NCT00445458
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : May 9, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Advanced Breast Cancer
Advanced Malignant Solid Tumors
Breast Neoplasms
Interventions Drug: HKI-272
Drug: Paclitaxel
Enrollment 110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neratinib 160 mg + Paclitaxel 80 mg/m2 Neratinib 240 mg + Paclitaxel 80 mg/m2 Arm A Neratinib (MTD) + Paclitaxel 80 mg/m2 Arm B Neratinib (MTD) + Paclitaxel 80 mg/m2
Hide Arm/Group Description Neratinib 160 mg qd + Paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Neratinib 240 mg qd + Paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Neratinib (MTD) qd + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease. Neratinib (MTD) + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease.
Period Title: Overall Study
Started 3 5 71 31
Completed 0 0 3 3
Not Completed 3 5 68 28
Reason Not Completed
Disease Progression             3             4             54             27
Withdrawal by Subject             0             0             7             0
Adverse Event             0             0             3             0
Death             0             1             2             0
Physician Decision             0             0             1             1
Surgery             0             0             1             0
Arm/Group Title Neratinib 160 mg + Paclitaxel 80 mg/m2 Neratinib 240 mg + Paclitaxel 80 mg/m2 Arm A Neratinib (MTD) + Paclitaxel Arm B Neratinib (MTD) + Paclitaxel Total
Hide Arm/Group Description Neratinib 160 mg qd + Paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Neratinib 240 mg qd + Paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Neratinib (MTD) + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease Neratinib (MTD) + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease Total of all reporting groups
Overall Number of Baseline Participants 3 5 71 31 110
Hide Baseline Analysis Population Description
Safety population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 5 participants 71 participants 31 participants 110 participants
56.3  (14.57) 49.6  (11.72) 49.2  (10.10) 51.4  (8.50) 50.0  (9.82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 71 participants 31 participants 110 participants
Female
1
  33.3%
2
  40.0%
71
 100.0%
31
 100.0%
105
  95.5%
Male
2
  66.7%
3
  60.0%
0
   0.0%
0
   0.0%
5
   4.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 71 participants 31 participants 110 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
  66.7%
2
  40.0%
48
  67.6%
25
  80.6%
77
  70.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
1
   1.4%
0
   0.0%
1
   0.9%
White
0
   0.0%
3
  60.0%
22
  31.0%
5
  16.1%
30
  27.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  33.3%
0
   0.0%
0
   0.0%
1
   3.2%
2
   1.8%
1.Primary Outcome
Title Dose Limiting Toxicity Incidence of Neratinib in Combination With Paclitaxel
Hide Description Dose Limiting Toxicity in subjects with solid tumors treated with neratinib, administered daily, in combination with paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
Time Frame From first dose date through day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of Study Part 1. Treated set including patients eligible for MTD determination.
Arm/Group Title Neratinib 160 mg + Paclitaxel 80 mg/m² Neratinib 240 mg + Paclitaxel 80 mg/m²
Hide Arm/Group Description:
Neratinib 160 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
Neratinib 240 mg qd + Paclitaxel 80 mg/m² IV on days 1, 8, and 15 of a 28 day cycle.
Overall Number of Participants Analyzed 3 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Maximum Tolerated Dose
Hide Description Maximum Tolerated Dose (MTD) of neratinib, daily, in combination with paclitaxel 80 mg/m², intravenous at days 1, 8, and 15, associated with the dose limiting toxicity data.
Time Frame From first dose date through day 28.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population of Study Part 1. Treated set including patients eligible for MTD determination.
Arm/Group Title Part 1. Neratinib + Paclitaxel 80 mg/m²
Hide Arm/Group Description:
Daily Administration of Neratinib in combination with Paclitaxel 80 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle.
Overall Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: mg
240
3.Primary Outcome
Title Objective Response Rate
Hide Description Subjects with partial response (PR) or complete response (CR) with ERBB2 positive breast cancer treated at the maximum tolerated dose (MTD) of neratinib in combination with paclitaxel, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: CR, disappearance of all target lesions; PR, >=30% decrease in the sum of the longest diameter of target lesions; and no progressive disease (PD) for non-target lesions, and no new lesions.
Time Frame From first dose date to progression or last tumor assessment, up to 140 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects, in Study part 2 evaluable population, who met the inclusion/exclusion criteria, received at least 2 weeks of neratinib and at least 2 doses of paclitaxel, and underwent at least 1 post-Baseline tumor assessment. Subjects who died or had symptomatic deterioration before the first scheduled post-Baseline tumor assessment were included.
Arm/Group Title Arm A Neratinib (MTD) + Paclitaxel Arm B Neratinib (MTD) + Paclitaxel
Hide Arm/Group Description:
Neratinib (MTD) + Paclitaxel 80 mg/m² on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease.
Neratinib (MTD) + Paclitaxel 80 mg/m² on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 3 prior cytotoxic chemotherapy treatment regimens for metastatic disease.
Overall Number of Participants Analyzed 68 31
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70.6
(58.3 to 81.0)
77.4
(58.9 to 90.4)
4.Secondary Outcome
Title Maximum Plasma Concentration of Neratinib
Hide Description Maximum plasma concentration of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.
Time Frame Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neratinib 160 mg + Paclitaxel 80 mg/m² Neratinib 240 mg + Paclitaxel 80 mg/m²
Hide Arm/Group Description:
Neratinib 160 mg, once a day, orally, in combination with paclitaxel 80 mg/m², IV, given on days 1, 8, and 15 of a 28 day cycle.
Neratinib 240 mg, once a day, orally, in combination with paclitaxel 80 mg/m², IV, given on days 1, 8, and 15 of a 28 day cycle.
Overall Number of Participants Analyzed 3 94
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
66.78
(25%)
80.42
(55%)
5.Secondary Outcome
Title Area Under the Concentration-time Curve 0-24
Hide Description Area under the concentration-time curve of neratinib; after each dosing of neratinib on Cycle 1 of Day 15, blood samples taken at regular time points.
Time Frame Samples taken at 0 hour and at 1, 2, 4, 6, 8, and 24 hours postdose on Day 15 of Cycle 1, and 1 predose sample on Day 1 in Cycle 1.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Neratinib 160 mg + Paclitaxel 80 mg/m² Neratinib 240 mg + Paclitaxel 80 mg/m²
Hide Arm/Group Description:
Neratinib 160 mg, once a day, orally, in combination with paclitaxel 80 mg/m², IV, given on days 1, 8, and 15 of a 28 day cycle.
Neratinib 240 mg, once a day, orally, in combination with paclitaxel 80 mg/m², IV, given on days 1, 8, and 15 of a 28 day cycle.
Overall Number of Participants Analyzed 3 94
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
684
(92%)
1274
(61%)
Time Frame From first dose through 28 days after last dose, up to 140 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neratinib 160 mg + Paclitaxel 80 mg/m2 Neratinib 240 mg+ Paclitaxel 80 mg/m2 Arm A Neratinib 240 mg (MTD) + Paclitaxel 80 mg/m2 Arm B Neratinib 240 mg (MTD) + Paclitaxel 80 mg/m2
Hide Arm/Group Description Neratinib 160 mg qd + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Neratinib 240 mg qd + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle. Neratinib (MTD) qd + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 1 prior cytotoxic chemotherapy treatment regimen for metastatic disease Neratinib (MTD) qd + Paclitaxel 80 mg/m2 on days 1, 8, and 15 of a 28 day cycle for subjects with not more than 3 prior cytotoxic chemotherapy treatment regimen for metastatic disease
All-Cause Mortality
Neratinib 160 mg + Paclitaxel 80 mg/m2 Neratinib 240 mg+ Paclitaxel 80 mg/m2 Arm A Neratinib 240 mg (MTD) + Paclitaxel 80 mg/m2 Arm B Neratinib 240 mg (MTD) + Paclitaxel 80 mg/m2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Neratinib 160 mg + Paclitaxel 80 mg/m2 Neratinib 240 mg+ Paclitaxel 80 mg/m2 Arm A Neratinib 240 mg (MTD) + Paclitaxel 80 mg/m2 Arm B Neratinib 240 mg (MTD) + Paclitaxel 80 mg/m2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)   4/5 (80.00%)   27/71 (38.03%)   4/31 (12.90%) 
Blood and lymphatic system disorders         
Anaemia  1  0/3 (0.00%)  2/5 (40.00%)  0/71 (0.00%)  1/31 (3.23%) 
Febrile neutropenia  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Leukopenia  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Cardiac disorders         
Sinus tachycardia  1  1/3 (33.33%)  0/5 (0.00%)  0/71 (0.00%)  0/31 (0.00%) 
Eye disorders         
Cataract  1  0/3 (0.00%)  0/5 (0.00%)  0/71 (0.00%)  1/31 (3.23%) 
Gastrointestinal disorders         
Abdominal discomfort  1  1/3 (33.33%)  0/5 (0.00%)  0/71 (0.00%)  0/31 (0.00%) 
Diarrhoea  1  1/3 (33.33%)  1/5 (20.00%)  6/71 (8.45%)  0/31 (0.00%) 
Nausea  1  0/3 (0.00%)  1/5 (20.00%)  0/71 (0.00%)  0/31 (0.00%) 
Vomiting  1  0/3 (0.00%)  1/5 (20.00%)  2/71 (2.82%)  0/31 (0.00%) 
General disorders         
Fatigue  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Gait disturbance  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Oedema peripheral  1  0/3 (0.00%)  0/5 (0.00%)  0/71 (0.00%)  1/31 (3.23%) 
Pyrexia  1  0/3 (0.00%)  1/5 (20.00%)  1/71 (1.41%)  0/31 (0.00%) 
Infections and infestations         
Bacteraemia  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Cellulitis  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Cystitis  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Fungaemia  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Malaria  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Pneumonia  1  0/3 (0.00%)  0/5 (0.00%)  2/71 (2.82%)  0/31 (0.00%) 
Sepsis  1  0/3 (0.00%)  1/5 (20.00%)  0/71 (0.00%)  0/31 (0.00%) 
Injury, poisoning and procedural complications         
Femur fracture  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Hip fracture  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Tibia fracture  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Investigations         
Ejection fraction decreased  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Electrocardiogram T wave inversion  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  0/3 (0.00%)  0/5 (0.00%)  2/71 (2.82%)  0/31 (0.00%) 
Hypoglycaemia  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Musculoskeletal and connective tissue disorders         
Bone pain  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Pain in extremity  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer metastatic  1  0/3 (0.00%)  0/5 (0.00%)  4/71 (5.63%)  0/31 (0.00%) 
Metastases to central nervous system  1  0/3 (0.00%)  0/5 (0.00%)  2/71 (2.82%)  1/31 (3.23%) 
Nervous system disorders         
Brain oedema  1  0/3 (0.00%)  0/5 (0.00%)  0/71 (0.00%)  1/31 (3.23%) 
Dizziness  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Loss of consciousness  1  0/3 (0.00%)  1/5 (20.00%)  0/71 (0.00%)  0/31 (0.00%) 
Transient ischaemic attack  1  0/3 (0.00%)  0/5 (0.00%)  0/71 (0.00%)  1/31 (3.23%) 
Psychiatric disorders         
Anxiety  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Renal and urinary disorders         
Renal failure acute  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/3 (0.00%)  1/5 (20.00%)  0/71 (0.00%)  0/31 (0.00%) 
Dyspnoea  1  0/3 (0.00%)  1/5 (20.00%)  2/71 (2.82%)  0/31 (0.00%) 
Pneumonitis  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Pulmonary embolism  1  0/3 (0.00%)  1/5 (20.00%)  1/71 (1.41%)  0/31 (0.00%) 
Skin and subcutaneous tissue disorders         
Ingrowing nail  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (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 160 mg + Paclitaxel 80 mg/m2 Neratinib 240 mg+ Paclitaxel 80 mg/m2 Arm A Neratinib 240 mg (MTD) + Paclitaxel 80 mg/m2 Arm B Neratinib 240 mg (MTD) + Paclitaxel 80 mg/m2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   5/5 (100.00%)   70/71 (98.59%)   31/31 (100.00%) 
Blood and lymphatic system disorders         
Anaemia  1  2/3 (66.67%)  2/5 (40.00%)  24/71 (33.80%)  11/31 (35.48%) 
Leukopenia  1  0/3 (0.00%)  0/5 (0.00%)  29/71 (40.85%)  15/31 (48.39%) 
Neutropenia  1  0/3 (0.00%)  1/5 (20.00%)  37/71 (52.11%)  17/31 (54.84%) 
Thrombocytopenia  1  0/3 (0.00%)  0/5 (0.00%)  4/71 (5.63%)  1/31 (3.23%) 
Cardiac disorders         
Arrhythmia  1  0/3 (0.00%)  1/5 (20.00%)  0/71 (0.00%)  0/31 (0.00%) 
Palpitations  1  0/3 (0.00%)  0/5 (0.00%)  4/71 (5.63%)  0/31 (0.00%) 
Ear and labyrinth disorders         
Tinnitus  1  0/3 (0.00%)  0/5 (0.00%)  0/71 (0.00%)  2/31 (6.45%) 
Gastrointestinal disorders         
Abdominal discomfort  1  0/3 (0.00%)  0/5 (0.00%)  3/71 (4.23%)  3/31 (9.68%) 
Abdominal distension  1  1/3 (33.33%)  1/5 (20.00%)  5/71 (7.04%)  1/31 (3.23%) 
Abdominal pain  1  0/3 (0.00%)  0/5 (0.00%)  8/71 (11.27%)  3/31 (9.68%) 
Abdominal pain upper  1  0/3 (0.00%)  0/5 (0.00%)  10/71 (14.08%)  3/31 (9.68%) 
Constipation  1  1/3 (33.33%)  0/5 (0.00%)  3/71 (4.23%)  1/31 (3.23%) 
Diarrhoea  1  1/3 (33.33%)  5/5 (100.00%)  65/71 (91.55%)  29/31 (93.55%) 
Dry mouth  1  0/3 (0.00%)  1/5 (20.00%)  4/71 (5.63%)  1/31 (3.23%) 
Dyspepsia  1  0/3 (0.00%)  2/5 (40.00%)  8/71 (11.27%)  4/31 (12.90%) 
Dysphagia  1  0/3 (0.00%)  1/5 (20.00%)  1/71 (1.41%)  0/31 (0.00%) 
Gastritis  1  0/3 (0.00%)  0/5 (0.00%)  5/71 (7.04%)  3/31 (9.68%) 
Gingival ulceration  1  0/3 (0.00%)  0/5 (0.00%)  2/71 (2.82%)  2/31 (6.45%) 
Mouth ulceration  1  0/3 (0.00%)  0/5 (0.00%)  5/71 (7.04%)  0/31 (0.00%) 
Nausea  1  0/3 (0.00%)  4/5 (80.00%)  26/71 (36.62%)  7/31 (22.58%) 
Rectal haemorrhage  1  0/3 (0.00%)  1/5 (20.00%)  0/71 (0.00%)  0/31 (0.00%) 
Stomatitis  1  0/3 (0.00%)  1/5 (20.00%)  13/71 (18.31%)  5/31 (16.13%) 
Vomiting  1  0/3 (0.00%)  3/5 (60.00%)  20/71 (28.17%)  4/31 (12.90%) 
General disorders         
Asthenia  1  0/3 (0.00%)  0/5 (0.00%)  13/71 (18.31%)  7/31 (22.58%) 
Axillary pain  1  0/3 (0.00%)  1/5 (20.00%)  0/71 (0.00%)  0/31 (0.00%) 
Fatigue  1  1/3 (33.33%)  1/5 (20.00%)  16/71 (22.54%)  6/31 (19.35%) 
Generalised oedema  1  0/3 (0.00%)  0/5 (0.00%)  0/71 (0.00%)  2/31 (6.45%) 
Local swelling  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  2/31 (6.45%) 
Malaise  1  1/3 (33.33%)  2/5 (40.00%)  1/71 (1.41%)  0/31 (0.00%) 
Mucosal inflammation  1  0/3 (0.00%)  0/5 (0.00%)  6/71 (8.45%)  2/31 (6.45%) 
Oedema peripheral  1  0/3 (0.00%)  2/5 (40.00%)  13/71 (18.31%)  5/31 (16.13%) 
Pain  1  1/3 (33.33%)  0/5 (0.00%)  2/71 (2.82%)  1/31 (3.23%) 
Pyrexia  1  0/3 (0.00%)  0/5 (0.00%)  18/71 (25.35%)  4/31 (12.90%) 
Immune system disorders         
Drug hypersensitivity  1  1/3 (33.33%)  2/5 (40.00%)  1/71 (1.41%)  0/31 (0.00%) 
Infections and infestations         
Catheter site infection  1  0/3 (0.00%)  0/5 (0.00%)  0/71 (0.00%)  2/31 (6.45%) 
Gastroenteritis  1  1/3 (33.33%)  0/5 (0.00%)  0/71 (0.00%)  0/31 (0.00%) 
Gingivitis  1  0/3 (0.00%)  0/5 (0.00%)  4/71 (5.63%)  1/31 (3.23%) 
Influenza  1  0/3 (0.00%)  1/5 (20.00%)  6/71 (8.45%)  1/31 (3.23%) 
Nasopharyngitis  1  0/3 (0.00%)  1/5 (20.00%)  7/71 (9.86%)  2/31 (6.45%) 
Oral herpes  1  0/3 (0.00%)  1/5 (20.00%)  0/71 (0.00%)  0/31 (0.00%) 
Paronychia  1  0/3 (0.00%)  0/5 (0.00%)  3/71 (4.23%)  2/31 (6.45%) 
Upper respiratory tract infection  1  0/3 (0.00%)  0/5 (0.00%)  9/71 (12.68%)  2/31 (6.45%) 
Urinary tract infection  1  0/3 (0.00%)  1/5 (20.00%)  10/71 (14.08%)  5/31 (16.13%) 
Investigations         
Alanine aminotransferase increased  1  0/3 (0.00%)  0/5 (0.00%)  10/71 (14.08%)  6/31 (19.35%) 
Aspartate aminotransferase increased  1  0/3 (0.00%)  0/5 (0.00%)  9/71 (12.68%)  4/31 (12.90%) 
Blood alkaline phosphatase increased  1  1/3 (33.33%)  0/5 (0.00%)  0/71 (0.00%)  0/31 (0.00%) 
Blood urine present  1  1/3 (33.33%)  0/5 (0.00%)  0/71 (0.00%)  0/31 (0.00%) 
Weight decreased  1  0/3 (0.00%)  2/5 (40.00%)  10/71 (14.08%)  2/31 (6.45%) 
Metabolism and nutrition disorders         
Decreased appetite  1  1/3 (33.33%)  3/5 (60.00%)  16/71 (22.54%)  8/31 (25.81%) 
Hypocalcaemia  1  0/3 (0.00%)  0/5 (0.00%)  6/71 (8.45%)  3/31 (9.68%) 
Hypokalaemia  1  0/3 (0.00%)  1/5 (20.00%)  7/71 (9.86%)  3/31 (9.68%) 
Hypomagnesaemia  1  0/3 (0.00%)  1/5 (20.00%)  1/71 (1.41%)  0/31 (0.00%) 
Hypophagia  1  0/3 (0.00%)  1/5 (20.00%)  0/71 (0.00%)  0/31 (0.00%) 
Hypoproteinaemia  1  0/3 (0.00%)  0/5 (0.00%)  0/71 (0.00%)  2/31 (6.45%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/3 (0.00%)  0/5 (0.00%)  6/71 (8.45%)  0/31 (0.00%) 
Back pain  1  1/3 (33.33%)  0/5 (0.00%)  3/71 (4.23%)  5/31 (16.13%) 
Bone pain  1  0/3 (0.00%)  0/5 (0.00%)  5/71 (7.04%)  1/31 (3.23%) 
Muscle spasms  1  0/3 (0.00%)  0/5 (0.00%)  3/71 (4.23%)  2/31 (6.45%) 
Musculoskeletal chest pain  1  0/3 (0.00%)  1/5 (20.00%)  1/71 (1.41%)  0/31 (0.00%) 
Myalgia  1  0/3 (0.00%)  1/5 (20.00%)  3/71 (4.23%)  3/31 (9.68%) 
Pain in extremity  1  0/3 (0.00%)  0/5 (0.00%)  8/71 (11.27%)  3/31 (9.68%) 
Nervous system disorders         
Dizziness  1  0/3 (0.00%)  0/5 (0.00%)  7/71 (9.86%)  4/31 (12.90%) 
Headache  1  0/3 (0.00%)  0/5 (0.00%)  10/71 (14.08%)  5/31 (16.13%) 
Peripheral sensory neuropathy  1  2/3 (66.67%)  1/5 (20.00%)  36/71 (50.70%)  17/31 (54.84%) 
Psychiatric disorders         
Insomnia  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  2/31 (6.45%) 
Renal and urinary disorders         
Dysuria  1  1/3 (33.33%)  0/5 (0.00%)  3/71 (4.23%)  0/31 (0.00%) 
Hydronephrosis  1  1/3 (33.33%)  0/5 (0.00%)  0/71 (0.00%)  0/31 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  1/3 (33.33%)  1/5 (20.00%)  16/71 (22.54%)  2/31 (6.45%) 
Dyspnoea  1  1/3 (33.33%)  0/5 (0.00%)  9/71 (12.68%)  1/31 (3.23%) 
Epistaxis  1  1/3 (33.33%)  1/5 (20.00%)  5/71 (7.04%)  1/31 (3.23%) 
Nasal inflammation  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  2/31 (6.45%) 
Oropharyngeal pain  1  0/3 (0.00%)  0/5 (0.00%)  4/71 (5.63%)  0/31 (0.00%) 
Rhinorrhoea  1  0/3 (0.00%)  0/5 (0.00%)  3/71 (4.23%)  3/31 (9.68%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  0/3 (0.00%)  2/5 (40.00%)  37/71 (52.11%)  12/31 (38.71%) 
Decubitus ulcer  1  0/3 (0.00%)  1/5 (20.00%)  0/71 (0.00%)  0/31 (0.00%) 
Dermatitis acneiform  1  0/3 (0.00%)  0/5 (0.00%)  1/71 (1.41%)  2/31 (6.45%) 
Dry skin  1  1/3 (33.33%)  0/5 (0.00%)  1/71 (1.41%)  0/31 (0.00%) 
Nail disorder  1  0/3 (0.00%)  0/5 (0.00%)  2/71 (2.82%)  2/31 (6.45%) 
Palmar-plantar erythrodysaesthesia syndrome  1  0/3 (0.00%)  0/5 (0.00%)  2/71 (2.82%)  3/31 (9.68%) 
Pigmentation disorder  1  0/3 (0.00%)  0/5 (0.00%)  0/71 (0.00%)  2/31 (6.45%) 
Pruritus  1  0/3 (0.00%)  0/5 (0.00%)  7/71 (9.86%)  3/31 (9.68%) 
Rash  1  1/3 (33.33%)  2/5 (40.00%)  21/71 (29.58%)  8/31 (25.81%) 
Vascular disorders         
Hot flush  1  0/3 (0.00%)  1/5 (20.00%)  1/71 (1.41%)  1/31 (3.23%) 
Hypertension  1  0/3 (0.00%)  0/5 (0.00%)  5/71 (7.04%)  2/31 (6.45%) 
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
Layout table for Results Point of Contact information
Name/Title: Senior Director, Clinical Operations
Organization: Puma Biotechnology, Inc.
Phone: +1 (424) 248-6500
EMail: clinicaltrials@pumabiotechnology.com
Layout table for additonal information
Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00445458     History of Changes
Other Study ID Numbers: 3144A1-203 / B1891014
First Submitted: March 8, 2007
First Posted: March 9, 2007
Results First Submitted: August 10, 2017
Results First Posted: May 9, 2018
Last Update Posted: July 25, 2018