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Trial record 7 of 55 for:    hki-272 OR neratinib

Study Evaluating the Safety Of HKI-272 (Neratinib) In Subjects With Advanced Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00266877
Recruitment Status : Completed
First Posted : December 19, 2005
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Intervention Drug: HKI-272
Enrollment 172
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Prior Tarceva or Iressa With EGFR Mutation Prior Tarceva or Iressa w/o EGFR Mutation No Prior EGFR Tyrosine Kinase Inhibitor Treatment
Hide Arm/Group Description

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Period Title: Overall Study
Started 91 48 28
Completed 0 0 0
Not Completed 91 48 28
Reason Not Completed
Death             1             1             1
Adverse Event             6             4             1
Physician Decision             2             1             1
Withdrawal by Subject             3             1             1
Disease Progression             72             37             23
Symptomatic Deterioration             6             3             1
Hospitalization             1             0             0
Concomitant Radiotherapy             0             1             0
Arm/Group Title Prior Tarceva or Iressa With EGFR Mutation Prior Tarceva or Iressa w/o EGFR Mutation No Prior EGFR Tyrosine Kinase Inhibitor Treatment Total
Hide Arm/Group Description

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Total of all reporting groups
Overall Number of Baseline Participants 91 48 28 167
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 48 participants 28 participants 167 participants
< 60 years
45
  49.5%
24
  50.0%
13
  46.4%
82
  49.1%
>= 60 years
46
  50.5%
24
  50.0%
15
  53.6%
85
  50.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 48 participants 28 participants 167 participants
Female
74
  81.3%
26
  54.2%
18
  64.3%
118
  70.7%
Male
17
  18.7%
22
  45.8%
10
  35.7%
49
  29.3%
1.Primary Outcome
Title Objective Response Rate for Neratinib in Patients With Non-small Cell Lung Cancer
Hide Description Objective response rate as reported by Independent Assessment (radiographic review by independent radiologists) per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Time Frame From first dose date to progression/death or last tumor assessment, up to three years.
Hide Outcome Measure Data
Hide Analysis Population Description
modified ITT: Subjects who were randomized and who had taken at least 1 dose of neratinib; equivalent to the safety population
Arm/Group Title Prior Tarceva or Iressa With EGFR Mutation Prior Tarceva or Iressa w/o EGFR Mutation No Prior EGFR Tyrosine Kinase Inhibitor Treatment
Hide Arm/Group Description:

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Overall Number of Participants Analyzed 91 48 28
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
3.3
(0.9 to 8.3)
0
(0 to 6.05)
3.6
(0.18 to 15.85)
2.Secondary Outcome
Title Clinical Benefit Rate for Neratinib in Patients With Non-small Cell Lung Cancer
Hide Description Clinical benefit rate is the percentage of patients with Partial or Complete Response, or with Stable Disease >= 12 Weeks per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time Frame From first dose date to progression/death or last tumor assessment, up to three years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prior Tarceva or Iressa With EGFR Mutation Prior Tarceva or Iressa w/o EGFR Mutation No Prior EGFR Tyrosine Kinase Inhibitor Treatment
Hide Arm/Group Description:

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Overall Number of Participants Analyzed 91 48 28
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
9.9
(5.26 to 16.62)
6.3
(1.73 to 15.37)
10.7
(2.98 to 25.42)
3.Secondary Outcome
Title Duration of Response for Neratinib in Patients With Non-small Cell Lung Cancer
Hide Description Measured from the time at which measurement criteria were first met for CR or PR (whichever status was recorded first), until the date of first recurrence, PD, or death was objectively documented, taking as a reference for PD the smallest measurements recorded since enrollment, per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.0: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; and Non-PD for non-target lesions, and no new lesions.
Time Frame From start date of response to first PD, assessed up to three years after the first randomization.
Hide Outcome Measure Data
Hide Analysis Population Description
Number of subjects with PR or higher response.
Arm/Group Title Prior Tarceva or Iressa With EGFR Mutation Prior Tarceva or Iressa w/o EGFR Mutation No Prior EGFR Tyrosine Kinase Inhibitor Treatment
Hide Arm/Group Description:

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Overall Number of Participants Analyzed 3 0 1
Median (90% Confidence Interval)
Unit of Measure: weeks
54.1
(17.9 to 54.1)
28.7 [1] 
(NA to NA)
[1]
Insufficient number of participants with events.
4.Secondary Outcome
Title Progression Free Survival for Neratinib in Patients With Non-small Cell Lung Cancer
Hide Description Defined as the interval from the date of randomization until the first date on which recurrence or progression, or death due to any cause, is documented, censored at the last assessable evaluation or at the initiation of new anticancer therapy. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v 1.0 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame From first dose date to progression/death, assessed up to three years.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Prior Tarceva or Iressa With EGFR Mutation Prior Tarceva or Iressa w/o EGFR Mutation No Prior EGFR Tyrosine Kinase Inhibitor Treatment
Hide Arm/Group Description:

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Overall Number of Participants Analyzed 91 48 28
Median (90% Confidence Interval)
Unit of Measure: weeks
15.3
(11.9 to 15.7)
16.1
(15.0 to 23.9)
9.3
(6.4 to 18.9)
Time Frame First dose through 28 days after last dose, assessed up to three years.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Prior Tarceva or Iressa With EGFR Mutation Prior Tarceva or Iressa w/o EGFR Mutation No Prior EGFR Tyrosine Kinase Inhibitor Treatment
Hide Arm/Group Description

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients whose disease has progressed following > or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, < or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)

HKI-272: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

All-Cause Mortality
Prior Tarceva or Iressa With EGFR Mutation Prior Tarceva or Iressa w/o EGFR Mutation No Prior EGFR Tyrosine Kinase Inhibitor Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Prior Tarceva or Iressa With EGFR Mutation Prior Tarceva or Iressa w/o EGFR Mutation No Prior EGFR Tyrosine Kinase Inhibitor Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   33/91 (36.26%)   21/48 (43.75%)   14/28 (50.00%) 
Blood and lymphatic system disorders       
Anaemia  1  0/91 (0.00%)  0/48 (0.00%)  1/28 (3.57%) 
Neutropenia  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Thrombocytopenia  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Cardiac disorders       
Pericardial effusion  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Sinus tachycardia  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Supraventricular tachycardia  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Ear and labyrinth disorders       
Deafness unilateral  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  2/91 (2.20%)  0/48 (0.00%)  0/28 (0.00%) 
Acute abdomen  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Ascites  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Diarrhoea  1  2/91 (2.20%)  1/48 (2.08%)  2/28 (7.14%) 
Nausea  1  4/91 (4.40%)  0/48 (0.00%)  1/28 (3.57%) 
Vomiting  1  2/91 (2.20%)  1/48 (2.08%)  2/28 (7.14%) 
General disorders       
Fatigue  1  0/91 (0.00%)  0/48 (0.00%)  1/28 (3.57%) 
General physical health deterioration  1  5/91 (5.49%)  3/48 (6.25%)  3/28 (10.71%) 
Hyperthermia  1  0/91 (0.00%)  0/48 (0.00%)  1/28 (3.57%) 
Pyrexia  1  1/91 (1.10%)  0/48 (0.00%)  1/28 (3.57%) 
Unevaluable event  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Infections and infestations       
Bacteraemia  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Bronchitis  1  0/91 (0.00%)  0/48 (0.00%)  1/28 (3.57%) 
Escherichia urinary tract infection  1  0/91 (0.00%)  0/48 (0.00%)  1/28 (3.57%) 
Infection  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Lung infection  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Pneumonia  1  0/91 (0.00%)  3/48 (6.25%)  0/28 (0.00%) 
Injury, poisoning and procedural complications       
Accidental overdose  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Overdose  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Spinal compression fracture  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Metabolism and nutrition disorders       
Dehydration  1  1/91 (1.10%)  2/48 (4.17%)  2/28 (7.14%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  1/91 (1.10%)  1/48 (2.08%)  1/28 (3.57%) 
Bone pain  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Intervertebral disc protrusion  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Muscular weakness  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Spinal pain  1  0/91 (0.00%)  0/48 (0.00%)  1/28 (3.57%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Metastases to meninges  1  2/91 (2.20%)  0/48 (0.00%)  0/28 (0.00%) 
Non-small cell lung cancer  1  4/91 (4.40%)  3/48 (6.25%)  1/28 (3.57%) 
Prostate cancer  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Tumour pain  1  0/91 (0.00%)  0/48 (0.00%)  1/28 (3.57%) 
Nervous system disorders       
Cerebral ischaemia  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Cerebral venous thrombosis  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Coma  1  0/91 (0.00%)  0/48 (0.00%)  1/28 (3.57%) 
Convulsion  1  0/91 (0.00%)  1/48 (2.08%)  1/28 (3.57%) 
Dizziness  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Headache  1  2/91 (2.20%)  0/48 (0.00%)  1/28 (3.57%) 
Loss of consciousness  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Memory impairment  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Radicular syndrome  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Sciatica  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Speech disorder  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Syncope  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Psychiatric disorders       
Agitation  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Confusional state  1  2/91 (2.20%)  0/48 (0.00%)  0/28 (0.00%) 
Renal and urinary disorders       
Renal failure  1  1/91 (1.10%)  0/48 (0.00%)  1/28 (3.57%) 
Urinary retention  1  0/91 (0.00%)  0/48 (0.00%)  1/28 (3.57%) 
Respiratory, thoracic and mediastinal disorders       
Atelectasis  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Dyspnoea  1  4/91 (4.40%)  1/48 (2.08%)  3/28 (10.71%) 
Haemoptysis  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Pleural effusion  1  7/91 (7.69%)  4/48 (8.33%)  1/28 (3.57%) 
Pneumothorax  1  0/91 (0.00%)  1/48 (2.08%)  1/28 (3.57%) 
Pulmonary embolism  1  1/91 (1.10%)  1/48 (2.08%)  1/28 (3.57%) 
Pulmonary hypertension  1  1/91 (1.10%)  0/48 (0.00%)  0/28 (0.00%) 
Respiratory failure  1  0/91 (0.00%)  0/48 (0.00%)  1/28 (3.57%) 
Skin and subcutaneous tissue disorders       
Rash  1  0/91 (0.00%)  1/48 (2.08%)  0/28 (0.00%) 
Vascular disorders       
Superior vena cava syndrome  1  0/91 (0.00%)  0/48 (0.00%)  1/28 (3.57%) 
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%
Prior Tarceva or Iressa With EGFR Mutation Prior Tarceva or Iressa w/o EGFR Mutation No Prior EGFR Tyrosine Kinase Inhibitor Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   91/91 (100.00%)   46/48 (95.83%)   26/28 (92.86%) 
Blood and lymphatic system disorders       
Anaemia  1  11/91 (12.09%)  9/48 (18.75%)  8/28 (28.57%) 
Lymphopenia  1  11/91 (12.09%)  4/48 (8.33%)  8/28 (28.57%) 
Gastrointestinal disorders       
Abdominal distension  1  6/91 (6.59%)  2/48 (4.17%)  4/28 (14.29%) 
Abdominal pain  1  36/91 (39.56%)  14/48 (29.17%)  5/28 (17.86%) 
Abdominal pain upper  1  8/91 (8.79%)  2/48 (4.17%)  1/28 (3.57%) 
Constipation  1  10/91 (10.99%)  4/48 (8.33%)  4/28 (14.29%) 
Diarrhoea  1  85/91 (93.41%)  41/48 (85.42%)  25/28 (89.29%) 
Dry mouth  1  1/91 (1.10%)  3/48 (6.25%)  1/28 (3.57%) 
Dyspepsia  1  4/91 (4.40%)  2/48 (4.17%)  3/28 (10.71%) 
Dysphagia  1  2/91 (2.20%)  0/48 (0.00%)  2/28 (7.14%) 
Flatulence  1  5/91 (5.49%)  1/48 (2.08%)  2/28 (7.14%) 
Gastrooesophageal reflux disease  1  2/91 (2.20%)  3/48 (6.25%)  1/28 (3.57%) 
Haemorrhoids  1  0/91 (0.00%)  0/48 (0.00%)  2/28 (7.14%) 
Nausea  1  52/91 (57.14%)  24/48 (50.00%)  16/28 (57.14%) 
Vomiting  1  36/91 (39.56%)  14/48 (29.17%)  9/28 (32.14%) 
General disorders       
Asthenia  1  22/91 (24.18%)  9/48 (18.75%)  6/28 (21.43%) 
Chest pain  1  12/91 (13.19%)  7/48 (14.58%)  2/28 (7.14%) 
Fatigue  1  36/91 (39.56%)  19/48 (39.58%)  7/28 (25.00%) 
Oedema peripheral  1  2/91 (2.20%)  3/48 (6.25%)  1/28 (3.57%) 
Pyrexia  1  11/91 (12.09%)  6/48 (12.50%)  4/28 (14.29%) 
Hepatobiliary disorders       
Hyperbilirubinaemia  1  0/91 (0.00%)  0/48 (0.00%)  3/28 (10.71%) 
Infections and infestations       
Folliculitis  1  1/91 (1.10%)  0/48 (0.00%)  2/28 (7.14%) 
Nasopharyngitis  1  2/91 (2.20%)  1/48 (2.08%)  4/28 (14.29%) 
Pulpitis dental  1  0/91 (0.00%)  0/48 (0.00%)  2/28 (7.14%) 
Rhinitis  1  2/91 (2.20%)  1/48 (2.08%)  2/28 (7.14%) 
Upper respiratory tract infection  1  3/91 (3.30%)  6/48 (12.50%)  1/28 (3.57%) 
Investigations       
Alanine aminotransferase increased  1  7/91 (7.69%)  1/48 (2.08%)  3/28 (10.71%) 
Amylase increased  1  6/91 (6.59%)  0/48 (0.00%)  2/28 (7.14%) 
Aspartate aminotransferase increased  1  4/91 (4.40%)  2/48 (4.17%)  3/28 (10.71%) 
Blood alkaline phosphatase increased  1  3/91 (3.30%)  4/48 (8.33%)  4/28 (14.29%) 
Blood creatinine increased  1  3/91 (3.30%)  2/48 (4.17%)  2/28 (7.14%) 
Blood lactate dehydrogenase increased  1  2/91 (2.20%)  4/48 (8.33%)  4/28 (14.29%) 
Gamma-glutamyltransferase increased  1  5/91 (5.49%)  5/48 (10.42%)  2/28 (7.14%) 
Protein total decreased  1  0/91 (0.00%)  3/48 (6.25%)  2/28 (7.14%) 
Weight decreased  1  7/91 (7.69%)  8/48 (16.67%)  4/28 (14.29%) 
Metabolism and nutrition disorders       
Cell death  1  4/91 (4.40%)  0/48 (0.00%)  3/28 (10.71%) 
Decreased appetite  1  35/91 (38.46%)  16/48 (33.33%)  11/28 (39.29%) 
Dehydration  1  15/91 (16.48%)  6/48 (12.50%)  4/28 (14.29%) 
Hyperkalaemia  1  5/91 (5.49%)  0/48 (0.00%)  3/28 (10.71%) 
Hypoalbuminaemia  1  1/91 (1.10%)  3/48 (6.25%)  2/28 (7.14%) 
Hypocalcaemia  1  0/91 (0.00%)  4/48 (8.33%)  2/28 (7.14%) 
Hypokalaemia  1  4/91 (4.40%)  3/48 (6.25%)  3/28 (10.71%) 
Hyponatraemia  1  2/91 (2.20%)  3/48 (6.25%)  1/28 (3.57%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  13/91 (14.29%)  6/48 (12.50%)  4/28 (14.29%) 
Back pain  1  14/91 (15.38%)  7/48 (14.58%)  7/28 (25.00%) 
Muscle spasms  1  3/91 (3.30%)  2/48 (4.17%)  2/28 (7.14%) 
Musculoskeletal chest pain  1  6/91 (6.59%)  4/48 (8.33%)  1/28 (3.57%) 
Musculoskeletal pain  1  4/91 (4.40%)  3/48 (6.25%)  0/28 (0.00%) 
Neck pain  1  1/91 (1.10%)  3/48 (6.25%)  1/28 (3.57%) 
Pain in extremity  1  6/91 (6.59%)  1/48 (2.08%)  1/28 (3.57%) 
Nervous system disorders       
Dizziness  1  11/91 (12.09%)  4/48 (8.33%)  0/28 (0.00%) 
Dysgeusia  1  4/91 (4.40%)  2/48 (4.17%)  4/28 (14.29%) 
Headache  1  15/91 (16.48%)  8/48 (16.67%)  4/28 (14.29%) 
Hypoaesthesia  1  2/91 (2.20%)  0/48 (0.00%)  2/28 (7.14%) 
Neuralgia  1  0/91 (0.00%)  0/48 (0.00%)  3/28 (10.71%) 
Paraesthesia  1  0/91 (0.00%)  2/48 (4.17%)  2/28 (7.14%) 
Psychiatric disorders       
Confusional state  1  2/91 (2.20%)  3/48 (6.25%)  0/28 (0.00%) 
Depression  1  6/91 (6.59%)  3/48 (6.25%)  2/28 (7.14%) 
Disorientation  1  0/91 (0.00%)  0/48 (0.00%)  2/28 (7.14%) 
Insomnia  1  6/91 (6.59%)  2/48 (4.17%)  2/28 (7.14%) 
Renal and urinary disorders       
Haematuria  1  3/91 (3.30%)  0/48 (0.00%)  3/28 (10.71%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  28/91 (30.77%)  5/48 (10.42%)  8/28 (28.57%) 
Dysphonia  1  1/91 (1.10%)  2/48 (4.17%)  3/28 (10.71%) 
Dyspnoea  1  26/91 (28.57%)  13/48 (27.08%)  8/28 (28.57%) 
Epistaxis  1  5/91 (5.49%)  0/48 (0.00%)  3/28 (10.71%) 
Oropharyngeal pain  1  2/91 (2.20%)  1/48 (2.08%)  4/28 (14.29%) 
Pleural effusion  1  7/91 (7.69%)  4/48 (8.33%)  0/28 (0.00%) 
Rhinorrhoea  1  3/91 (3.30%)  1/48 (2.08%)  2/28 (7.14%) 
Skin and subcutaneous tissue disorders       
Alopecia  1  2/91 (2.20%)  1/48 (2.08%)  3/28 (10.71%) 
Dermatitis acneiform  1  3/91 (3.30%)  2/48 (4.17%)  4/28 (14.29%) 
Dry skin  1  15/91 (16.48%)  7/48 (14.58%)  5/28 (17.86%) 
Eczema  1  2/91 (2.20%)  0/48 (0.00%)  2/28 (7.14%) 
Erythema  1  8/91 (8.79%)  2/48 (4.17%)  2/28 (7.14%) 
Pruritus  1  7/91 (7.69%)  2/48 (4.17%)  0/28 (0.00%) 
Rash  1  16/91 (17.58%)  8/48 (16.67%)  9/28 (32.14%) 
Skin fissures  1  2/91 (2.20%)  2/48 (4.17%)  2/28 (7.14%) 
Vascular disorders       
Thrombosis  1  0/91 (0.00%)  0/48 (0.00%)  2/28 (7.14%) 
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: NCT00266877     History of Changes
Other Study ID Numbers: 3144A1-200
B1891037
First Submitted: December 16, 2005
First Posted: December 19, 2005
Results First Submitted: August 10, 2017
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018