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Trial record 61 of 125 for:    lapatinib | Recruiting, Active, not recruiting, Completed Studies | Phase 2

Study Evaluating Neratinib Versus Lapatinib Plus Capecitabine For ErbB2 Positive Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT00777101
Recruitment Status : Completed
First Posted : October 22, 2008
Results First Posted : November 9, 2017
Last Update Posted : August 9, 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 Advanced Breast Cancer
Breast Cancer
Interventions Drug: Neratinib
Drug: Lapatinib
Drug: Capecitabine
Enrollment 233
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neratinib Lapatinib+Capecitabine
Hide Arm/Group Description

Neratinib

Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity

Lapatinib plus Capecitabine

Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.

Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Period Title: Overall Study
Started 117 116
Treated 116 115
Completed 55 65
Not Completed 62 51
Reason Not Completed
Death             48             43
Withdrawal by Subject             11             6
Lost to Follow-up             2             1
Discontinuation of Study by Sponsor             1             0
Failed to Return             0             1
Arm/Group Title Neratinib Lapatinib+Capecitabine Total
Hide Arm/Group Description

Neratinib

Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity

Lapatinib plus Capecitabine

Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.

Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Total of all reporting groups
Overall Number of Baseline Participants 117 116 233
Hide Baseline Analysis Population Description
Randomized Population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 116 participants 233 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
104
  88.9%
100
  86.2%
204
  87.6%
>=65 years
13
  11.1%
16
  13.8%
29
  12.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 117 participants 116 participants 233 participants
53.1  (10.11) 54.7  (13.8) 54.3  (12.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants 116 participants 233 participants
Female
117
 100.0%
116
 100.0%
233
 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 117 participants 116 participants 233 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
32
  27.4%
46
  39.7%
78
  33.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
   3.4%
2
   1.7%
6
   2.6%
White
77
  65.8%
64
  55.2%
141
  60.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
4
   3.4%
4
   3.4%
8
   3.4%
1.Primary Outcome
Title Progression Free Survival
Hide Description Progression Free Survival, Measured in Months, for Subjects Randomized. Investigator assessment. The time interval from the date of randomization until the earliest date of progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) or death due to any cause. For subjects without death or progression, censorship was at the last valid tumor assessment.
Time Frame From randomization date to progression or death, assessed up to 69 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population, includes all subjects who were randomized.
Arm/Group Title Neratinib Lapatinib+Capecitabine
Hide Arm/Group Description:

Neratinib

Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity

Lapatinib plus Capecitabine

Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.

Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 117 116
Median (95% Confidence Interval)
Unit of Measure: months
4.53
(3.12 to 5.65)
6.83
(5.85 to 8.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Neratinib, Lapatinib+Capecitabine
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority of neratinib vs lapatinib + capecitabine was to be concluded if the upper limit of the 95% confidence interval (CI) for the hazard ratio was 1.15 or less.
Statistical Test of Hypothesis P-Value 0.231
Comments [Not Specified]
Method Log Rank
Comments The log-rank test comparing treatment groups is stratified by region.
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.19
Confidence Interval (2-Sided) 95%
0.89 to 1.60
Estimation Comments The hazard ratio is estimated by stratified Cox model. The Cox model is stratified by region.
2.Secondary Outcome
Title Overall Survival (OS)
Hide Description Overall Survival (OS) was defined as the time from randomization to death due to any cause. Subjects last known to be alive were censored at the last date of last contact or the data cutoff employed for the analysis, whichever was earlier.
Time Frame From randomization date to death, assessed up to 69 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population, includes all subjects who were randomized.
Arm/Group Title Neratinib Lapatinib+Capecitabine
Hide Arm/Group Description:

Neratinib

Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity

Lapatinib plus Capecitabine

Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.

Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 117 116
Median (95% Confidence Interval)
Unit of Measure: months
19.74 [1] 
(18.20 to NA)
23.62 [1] 
(18.00 to NA)
[1]
Insufficient number of participants to calculate the upper bound of the confidence interval.
3.Secondary Outcome
Title Objective Response Rate (ORR).
Hide Description Objective Response Rate, investigator assessment. The ORR was defined as the percentage of participants demonstrating a confirmed objective response, either Complete Response (CR) or Partial Response (PR) during the study per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v.1.0: 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 randomization date to progression or last tumor assessment, assessed up to 69 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population, includes all subjects who were randomized.
Arm/Group Title Neratinib Lapatinib+Capecitabine
Hide Arm/Group Description:

Neratinib

Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity

Lapatinib plus Capecitabine

Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.

Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 117 116
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
29.1
(21 to 38.2)
40.5
(31.5 to 50.0)
4.Secondary Outcome
Title Clinical Benefit Rate
Hide Description

Clinical benefit rate (CR, PR, or SD = 24 weeks) for women For ErbB2 Positive Advanced Breast Cancer. Clinical benefit rate was the percentage of subjects who achieved overall tumor response 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; 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.

Clinical Benefit (CB) = CR + PR + SD >= 24 weeks.

Time Frame From randomization date to progression or last tumor assessment, assessed up to 69 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population, includes all subjects who were randomized.
Arm/Group Title Neratinib Lapatinib+Capecitabine
Hide Arm/Group Description:

Neratinib

Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity

Lapatinib plus Capecitabine

Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.

Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 117 116
Median (95% Confidence Interval)
Unit of Measure: percentage of participants
44.4
(35.3 to 53.9)
63.8
(54.4 to 72.5)
5.Secondary Outcome
Title Duration of Response
Hide Description Duration of response was measured from the time at which response criteria were met for complete response (CR) or partial response (PR) (whichever status was recorded first) until the first date of recurrence or progressive disease (PD) or death. For subjects without death or progression, censorship was at the last valid tumor assessment 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.
Time Frame From start date of response to first PD, assessed up to 69 months after the first subject was randomized.
Hide Outcome Measure Data
Hide Analysis Population Description
No. of Subjects with either complete or partial response.
Arm/Group Title Neratinib Lapatinib+Capecitabine
Hide Arm/Group Description:

Neratinib

Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity

Lapatinib plus Capecitabine

Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.

Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 34 47
Median (95% Confidence Interval)
Unit of Measure: months
12.48
(8.31 to 14.75)
7.98
(5.49 to 11.76)
6.Secondary Outcome
Title Frequency of CNS Metastases (Frequency)
Hide Description The percent of patients with symptomatic or progressive CNS lesions was the proportion of subjects who had PD considering CNS lesions only, according to RECIST criteria.
Time Frame From randomization date to first CNS symptom or lesions
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population, includes all subjects who were randomized.
Arm/Group Title Neratinib Lapatinib+Capecitabine
Hide Arm/Group Description:

Neratinib

Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity

Lapatinib+Capecitabine

Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.

Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 117 116
Measure Type: Number
Unit of Measure: percentage of participants
9.4 12.9
7.Secondary Outcome
Title Time to CNS Metastases
Hide Description Time to symptomatic or progressive Central nervous system (CNS) lesions. Time to symptomatic or progressive CNS lesions was the time from the date of randomization until the date of progressive disease (PD) considering CNS lesions only (ie, appearance of newly diagnosed CNS lesions or progressive CNS lesions).
Time Frame From randomization date to first CNS symptom or lesions
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat population, includes all subjects who were randomized.
Arm/Group Title Neratinib Lapatinib+Capecitabine
Hide Arm/Group Description:

Neratinib

Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity

Lapatinib+Capecitabine

Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.

Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

Overall Number of Participants Analyzed 117 116
Median (95% Confidence Interval)
Unit of Measure: months
19.68
(19.68 to 20.99)
NA [1] 
(NA to NA)
[1]
Insufficient number of participants with events to calculate the median and confidence intervals.
Time Frame From First Dose through 28 days after last dose, assessed up to 69 months.
Adverse Event Reporting Description See below
 
Arm/Group Title Neratinib Lapatinib+Capecitabine
Hide Arm/Group Description

Neratinib

Neratinib: Tablets, 240mg once per day until disease progression or unacceptable toxicity

Lapatinib+Capecitabine

Lapatinib: Tablets 1250mg once per day until disease progression or unacceptable toxicity.

Capecitabine: Tablets 2000mg/m2 given in two evenly divided daily doses for first 14 days of each 21 day cycle. Given until disease progression or unacceptable toxicity.

All-Cause Mortality
Neratinib Lapatinib+Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Neratinib Lapatinib+Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   31/116 (26.72%)   24/115 (20.87%) 
Blood and lymphatic system disorders     
Neutropenia  1  1/116 (0.86%)  1/115 (0.87%) 
Thrombocytopenia  1  1/116 (0.86%)  0/115 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  1/116 (0.86%)  0/115 (0.00%) 
Myocardial infarction  1  0/116 (0.00%)  1/115 (0.87%) 
Pericardial effusion  1  0/116 (0.00%)  1/115 (0.87%) 
Gastrointestinal disorders     
Abdominal pain  1  3/116 (2.59%)  0/115 (0.00%) 
Ascites  1  1/116 (0.86%)  0/115 (0.00%) 
Diarrhoea  1  3/116 (2.59%)  4/115 (3.48%) 
Gingival bleeding  1  1/116 (0.86%)  0/115 (0.00%) 
Intestinal haemorrhage  1  1/116 (0.86%)  0/115 (0.00%) 
Nausea  1  2/116 (1.72%)  3/115 (2.61%) 
Stomatitis  1  0/116 (0.00%)  1/115 (0.87%) 
Vomiting  1  2/116 (1.72%)  3/115 (2.61%) 
General disorders     
Asthenia  1  1/116 (0.86%)  0/115 (0.00%) 
Chills  1  1/116 (0.86%)  0/115 (0.00%) 
Disease progression  1  1/116 (0.86%)  0/115 (0.00%) 
Fatigue  1  1/116 (0.86%)  2/115 (1.74%) 
Pain  1  1/116 (0.86%)  0/115 (0.00%) 
Pyrexia  1  2/116 (1.72%)  3/115 (2.61%) 
Sudden death  1  0/116 (0.00%)  1/115 (0.87%) 
Hepatobiliary disorders     
Hepatic failure  1  0/116 (0.00%)  1/115 (0.87%) 
Hepatic function abnormal  1  1/116 (0.86%)  0/115 (0.00%) 
Infections and infestations     
Bronchopneumonia  1  1/116 (0.86%)  1/115 (0.87%) 
Cellulitis  1  0/116 (0.00%)  1/115 (0.87%) 
Device related infection  1  1/116 (0.86%)  0/115 (0.00%) 
Erysipelas  1  1/116 (0.86%)  0/115 (0.00%) 
Mastitis  1  0/116 (0.00%)  1/115 (0.87%) 
Pneumonia  1  0/116 (0.00%)  2/115 (1.74%) 
Sepsis  1  1/116 (0.86%)  0/115 (0.00%) 
Skin infection  1  0/116 (0.00%)  1/115 (0.87%) 
Upper respiratory tract infection  1  0/116 (0.00%)  1/115 (0.87%) 
Urinary tract infection  1  0/116 (0.00%)  1/115 (0.87%) 
Wound sepsis  1  0/116 (0.00%)  1/115 (0.87%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  0/116 (0.00%)  1/115 (0.87%) 
Radius fracture  1  0/116 (0.00%)  1/115 (0.87%) 
Metabolism and nutrition disorders     
Decreased appetite  1  1/116 (0.86%)  0/115 (0.00%) 
Dehydration  1  3/116 (2.59%)  1/115 (0.87%) 
Hypokalaemia  1  0/116 (0.00%)  1/115 (0.87%) 
Hyponatraemia  1  0/116 (0.00%)  1/115 (0.87%) 
Hypovolaemia  1  0/116 (0.00%)  1/115 (0.87%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  2/116 (1.72%)  1/115 (0.87%) 
Flank pain  1  1/116 (0.86%)  0/115 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cervix carcinoma stage 0  1  1/116 (0.86%)  0/115 (0.00%) 
Metastases to meninges  1  1/116 (0.86%)  0/115 (0.00%) 
Nervous system disorders     
Brain oedema  1  2/116 (1.72%)  0/115 (0.00%) 
Dizziness  1  0/116 (0.00%)  2/115 (1.74%) 
Encephalopathy  1  0/116 (0.00%)  1/115 (0.87%) 
Headache  1  1/116 (0.86%)  1/115 (0.87%) 
Ischaemic stroke  1  0/116 (0.00%)  1/115 (0.87%) 
Presyncope  1  1/116 (0.86%)  0/115 (0.00%) 
Renal and urinary disorders     
Renal failure acute  1  0/116 (0.00%)  1/115 (0.87%) 
Respiratory, thoracic and mediastinal disorders     
Alveolitis  1  0/116 (0.00%)  1/115 (0.87%) 
Dyspnoea  1  2/116 (1.72%)  0/115 (0.00%) 
Pleural effusion  1  1/116 (0.86%)  6/115 (5.22%) 
Pulmonary embolism  1  1/116 (0.86%)  0/115 (0.00%) 
Respiratory failure  1  4/116 (3.45%)  0/115 (0.00%) 
Skin and subcutaneous tissue disorders     
Nail disorder  1  0/116 (0.00%)  1/115 (0.87%) 
Skin irritation  1  0/116 (0.00%)  1/115 (0.87%) 
Vascular disorders     
Circulatory collapse  1  1/116 (0.86%)  0/115 (0.00%) 
Deep vein thrombosis  1  1/116 (0.86%)  0/115 (0.00%) 
Hypotension  1  0/116 (0.00%)  1/115 (0.87%) 
Lymphoedema  1  0/116 (0.00%)  1/115 (0.87%) 
Subclavian artery stenosis  1  0/116 (0.00%)  1/115 (0.87%) 
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 Lapatinib+Capecitabine
Affected / at Risk (%) Affected / at Risk (%)
Total   113/116 (97.41%)   114/115 (99.13%) 
Blood and lymphatic system disorders     
Anaemia  1  9/116 (7.76%)  5/115 (4.35%) 
Leukopenia  1  5/116 (4.31%)  12/115 (10.43%) 
Neutropenia  1  5/116 (4.31%)  17/115 (14.78%) 
Gastrointestinal disorders     
Abdominal pain  1  11/116 (9.48%)  14/115 (12.17%) 
Abdominal pain upper  1  8/116 (6.90%)  12/115 (10.43%) 
Constipation  1  8/116 (6.90%)  12/115 (10.43%) 
Diarrhoea  1  100/116 (86.21%)  82/115 (71.30%) 
Dyspepsia  1  13/116 (11.21%)  11/115 (9.57%) 
Nausea  1  50/116 (43.10%)  48/115 (41.74%) 
Stomatitis  1  9/116 (7.76%)  28/115 (24.35%) 
Vomiting  1  38/116 (32.76%)  25/115 (21.74%) 
General disorders     
Asthenia  1  22/116 (18.97%)  13/115 (11.30%) 
Fatigue  1  30/116 (25.86%)  30/115 (26.09%) 
Influenza like illness  1  4/116 (3.45%)  6/115 (5.22%) 
Mucosal inflammation  1  6/116 (5.17%)  19/115 (16.52%) 
Pain  1  7/116 (6.03%)  8/115 (6.96%) 
Pyrexia  1  6/116 (5.17%)  10/115 (8.70%) 
Hepatobiliary disorders     
Hyperbilirubinaemia  1  3/116 (2.59%)  27/115 (23.48%) 
Infections and infestations     
Cystitis  1  7/116 (6.03%)  5/115 (4.35%) 
Nasopharyngitis  1  3/116 (2.59%)  10/115 (8.70%) 
Paronychia  1  6/116 (5.17%)  24/115 (20.87%) 
Upper respiratory tract infection  1  6/116 (5.17%)  5/115 (4.35%) 
Urinary tract infection  1  6/116 (5.17%)  10/115 (8.70%) 
Investigations     
Alanine aminotransferase increased  1  11/116 (9.48%)  15/115 (13.04%) 
Aspartate aminotransferase increased  1  10/116 (8.62%)  19/115 (16.52%) 
Blood alkaline phosphatase increased  1  8/116 (6.90%)  4/115 (3.48%) 
Blood bilirubin increased  1  0/116 (0.00%)  6/115 (5.22%) 
Weight decreased  1  15/116 (12.93%)  13/115 (11.30%) 
Metabolism and nutrition disorders     
Decreased appetite  1  33/116 (28.45%)  23/115 (20.00%) 
Hypokalaemia  1  3/116 (2.59%)  7/115 (6.09%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  7/116 (6.03%)  4/115 (3.48%) 
Back pain  1  13/116 (11.21%)  5/115 (4.35%) 
Myalgia  1  6/116 (5.17%)  0/115 (0.00%) 
Neck pain  1  6/116 (5.17%)  0/115 (0.00%) 
Nervous system disorders     
Dizziness  1  6/116 (5.17%)  13/115 (11.30%) 
Dysgeusia  1  4/116 (3.45%)  8/115 (6.96%) 
Headache  1  24/116 (20.69%)  12/115 (10.43%) 
Peripheral sensory neuropathy  1  5/116 (4.31%)  10/115 (8.70%) 
Psychiatric disorders     
Insomnia  1  9/116 (7.76%)  8/115 (6.96%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  17/116 (14.66%)  6/115 (5.22%) 
Dyspnoea  1  9/116 (7.76%)  7/115 (6.09%) 
Oropharyngeal pain  1  7/116 (6.03%)  10/115 (8.70%) 
Skin and subcutaneous tissue disorders     
Acne  1  3/116 (2.59%)  6/115 (5.22%) 
Alopecia  1  0/116 (0.00%)  6/115 (5.22%) 
Dry skin  1  8/116 (6.90%)  10/115 (8.70%) 
Nail disorder  1  3/116 (2.59%)  13/115 (11.30%) 
Palmar-plantar erythrodysaesthesia syndrome  1  9/116 (7.76%)  77/115 (66.96%) 
Pruritus  1  4/116 (3.45%)  17/115 (14.78%) 
Rash  1  26/116 (22.41%)  41/115 (35.65%) 
Rash macular  1  0/116 (0.00%)  6/115 (5.22%) 
Skin hyperpigmentation  1  0/116 (0.00%)  12/115 (10.43%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (17.0)
Pharmacokinetic Analyses not included here; they are part of a population PK analysis.
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: NCT00777101     History of Changes
Other Study ID Numbers: 3144A2-3003 / B1891003
First Submitted: October 21, 2008
First Posted: October 22, 2008
Results First Submitted: August 10, 2017
Results First Posted: November 9, 2017
Last Update Posted: August 9, 2018