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Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive

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ClinicalTrials.gov Identifier: NCT00372424
Recruitment Status : Completed
First Posted : September 7, 2006
Results First Posted : October 30, 2012
Last Update Posted : December 28, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Herceptin
Drug: Sunitinib
Drug: Taxotere
Enrollment 26

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sunitinib + Docetaxel + Trastuzumab
Hide Arm/Group Description Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Period Title: Overall Study
Started 26
Treated 25
Completed 0
Not Completed 26
Reason Not Completed
Adverse Event             2
Withdrawal by Subject             1
Death             1
Objective Progression or Relapse             14
Other             7
Enrolled, Not Treated             1
Arm/Group Title Sunitinib + Docetaxel + Trastuzumab
Hide Arm/Group Description Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
57.0  (12.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
25
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame From screening until 28 days post last dose of study drug
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants enrolled in the study who received at least 1 dose of study medication.
Arm/Group Title Sunitinib + Docetaxel + Trastuzumab
Hide Arm/Group Description:
Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: participants
AEs 24
SAEs 11
2.Secondary Outcome
Title Percentage of Participants With Objective Response (OR)
Hide Description Percentage of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR are defined as disappearance of all target lesions. PR are those with at least 30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
Time Frame Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)
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Hide Analysis Population Description
Per protocol (PP) population included all participants who received at least 1 dose of sunitinib and had at least a tumor assessment post baseline.
Arm/Group Title Sunitinib + Docetaxel + Trastuzumab
Hide Arm/Group Description:
Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Overall Number of Participants Analyzed 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
72.7
(49.8 to 89.3)
3.Secondary Outcome
Title Progression-free Survival (PFS)
Hide Description Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Time Frame Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study population included all participants who received at least 1 dose of study medication.
Arm/Group Title Sunitinib + Docetaxel + Trastuzumab
Hide Arm/Group Description:
Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Overall Number of Participants Analyzed 25
Median (95% Confidence Interval)
Unit of Measure: weeks
58.4
(37.0 to 66.1)
4.Secondary Outcome
Title Duration of Response (DR)
Hide Description Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time Frame Baseline, assessed every 6 weeks starting from Day1 of Cycle 3 up to end of treatment (Day 1344)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Study population, subgroup of participants with a confirmed objective tumor response (CR or PR).
Arm/Group Title Sunitinib + Docetaxel + Trastuzumab
Hide Arm/Group Description:
Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Overall Number of Participants Analyzed 16
Median (95% Confidence Interval)
Unit of Measure: weeks
51.3
(32.0 to 60.1)
5.Secondary Outcome
Title Plasma Trough Concentrations (Ctrough) of SU011248 (Sunitinib), SU012662 (Sunitinib Metabolite) and Total Drug (SU011248+SU012662)
Hide Description Ctrough = the concentration prior to study medication administration. Ctrough was calculated for SU011248 (Sunitinib), SU012662 (Sunitinib metabolite) and total drug (SU011248+SU012662). Concentration values below the lower limit of quantification were taken as zero.
Time Frame Pre-dose (0 hours [H]) on Day 1 and Day 15 of Cycle 2, 4, 6 and additionally Day 15 of Cycle 1
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.
Arm/Group Title Sunitinib + Docetaxel + Trastuzumab
Hide Arm/Group Description:
Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: nanogram/milliliter (ng/mL)
Sunitinib: Cycle1/Day15 (n= 19) 40.17  (32.17)
Sunitinib: Cycle2/Day1 (n= 17) 5.96  (6.17)
Sunitinib: Cycle2/Day15 (n= 16) 37.29  (31.07)
Sunitinib: Cycle4/Day1 (n= 17) 5.26  (5.71)
Sunitinib: Cycle4/Day15 (n= 16) 43.21  (27.31)
Sunitinib: Cycle6/Day1 (n= 16) 3.36  (4.34)
Sunitinib: Cycle6/Day15 (n= 13) 28.46  (21.19)
Sunitinib Metabolite: Cycle1/Day15 (n= 19) 16.15  (12.09)
Sunitinib Metabolite: Cycle2/Day1 (n= 17) 4.76  (3.92)
Sunitinib Metabolite: Cycle2/Day15 (n= 16) 14.43  (11.34)
Sunitinib Metabolite: Cycle4/Day1 (n= 17) 3.95  (2.57)
Sunitinib Metabolite: Cycle4/Day15 (n= 16) 17.62  (11.17)
Sunitinib Metabolite: Cycle6/Day1 (n= 16) 2.96  (2.89)
Sunitinib Metabolite: Cycle6/Day15 (n= 13) 11.54  (9.66)
Total Drug: Cycle1/Day15 (n= 19) 56.31  (42.70)
Total Drug: Cycle2/Day1 (n= 17) 10.72  (9.80)
Total Drug: Cycle2/Day15 (n= 16) 51.72  (41.45)
Total Drug: Cycle4/Day1 (n= 17) 9.21  (7.97)
Total Drug: Cycle4/Day15 (n= 16) 60.83  (37.43)
Total Drug: Cycle6/Day1 (n= 16) 6.32  (7.02)
Total Drug: Cycle6/Day15 (n= 13) 40.00  (30.04)
6.Secondary Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Docetaxel
Hide Description Concentration values below the lower limit of quantification were taken as zero.
Time Frame End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included participants from study population who had completed sampling for pharmacokinetic profiles for study medication. 'n' is number of participants who were evaluable at given time points.
Arm/Group Title Sunitinib + Docetaxel + Trastuzumab
Hide Arm/Group Description:
Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle1/Day1 (n= 23) 1117.05  (1159.53)
Cycle2/Day1 (n= 19) 1388.63  (1260.94)
Cycle4/Day1 (n= 16) 1316.88  (1096.97)
Cycle6/Day1 (n= 15) 1670.40  (1614.07)
7.Secondary Outcome
Title Plasma Trough Concentrations (Ctrough) of Trastuzumab
Hide Description Ctrough = the concentration prior to study medication administration.
Time Frame Weekly trastuzumab: Pre-dose (0 H) on Day 1 and 15 of Cycle 1, 2, 4 and 6; 3-weekly trastuzumab: Pre-dose (0 H) on Day 1 of Cycle 1, 2, 4 and 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not summarized since majority of observed Ctrough values were below lower limit of quantification.
Arm/Group Title Sunitinib + Docetaxel + Trastuzumab
Hide Arm/Group Description:
Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Other Pre-specified Outcome
Title Maximum Observed Plasma Concentration (Cmax) of Paclitaxel
Hide Description [Not Specified]
Time Frame End of infusion (1 H) on Day 1 of Cycle 1, 2, 4 and 6
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data not analyzed since paclitaxel was not administered in the study.
Arm/Group Title Sunitinib + Docetaxel + Trastuzumab
Hide Arm/Group Description:
Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Sunitinib + Docetaxel + Trastuzumab
Hide Arm/Group Description Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
All-Cause Mortality
Sunitinib + Docetaxel + Trastuzumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Sunitinib + Docetaxel + Trastuzumab
Affected / at Risk (%)
Total   11/25 (44.00%) 
Blood and lymphatic system disorders   
Febrile neutropenia * 1  4/25 (16.00%) 
Neutropenia * 1  3/25 (12.00%) 
Gastrointestinal disorders   
Diarrhoea * 1  1/25 (4.00%) 
Intestinal perforation * 1  1/25 (4.00%) 
Rectal haemorrhage * 1  1/25 (4.00%) 
Stomatitis * 1  1/25 (4.00%) 
Vomiting * 1  1/25 (4.00%) 
General disorders   
Fatigue * 1  1/25 (4.00%) 
Multi-organ failure * 1  1/25 (4.00%) 
Infections and infestations   
Erysipelas * 1  1/25 (4.00%) 
Pseudomembranous colitis * 1  1/25 (4.00%) 
Sepsis * 1  1/25 (4.00%) 
Viral infection * 1  1/25 (4.00%) 
Musculoskeletal and connective tissue disorders   
Pathological fracture * 1  1/25 (4.00%) 
Nervous system disorders   
Syncope * 1  1/25 (4.00%) 
Psychiatric disorders   
Anxiety * 1  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders   
Acute respiratory distress syndrome * 1  1/25 (4.00%) 
Lung disorder * 1  1/25 (4.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Sunitinib + Docetaxel + Trastuzumab
Affected / at Risk (%)
Total   23/25 (92.00%) 
Blood and lymphatic system disorders   
Anaemia * 1  6/25 (24.00%) 
Febrile neutropenia * 1  2/25 (8.00%) 
Leukopenia * 1  6/25 (24.00%) 
Neutropenia * 1  14/25 (56.00%) 
Thrombocytopenia * 1  4/25 (16.00%) 
Eye disorders   
Conjunctivitis * 1  5/25 (20.00%) 
Lacrimation increased * 1  2/25 (8.00%) 
Gastrointestinal disorders   
Abdominal pain * 1  4/25 (16.00%) 
Abdominal pain upper * 1  7/25 (28.00%) 
Constipation * 1  4/25 (16.00%) 
Diarrhoea * 1  15/25 (60.00%) 
Dyspepsia * 1  2/25 (8.00%) 
Haemorrhoids * 1  3/25 (12.00%) 
Nausea * 1  11/25 (44.00%) 
Stomatitis * 1  7/25 (28.00%) 
Vomiting * 1  7/25 (28.00%) 
General disorders   
Asthenia * 1  4/25 (16.00%) 
Fatigue * 1  15/25 (60.00%) 
Mucosal inflammation * 1  4/25 (16.00%) 
Oedema * 1  2/25 (8.00%) 
Oedema peripheral * 1  6/25 (24.00%) 
Pyrexia * 1  13/25 (52.00%) 
Immune system disorders   
Drug hypersensitivity * 1  3/25 (12.00%) 
Hypersensitivity * 1  2/25 (8.00%) 
Infections and infestations   
Bronchitis * 1  2/25 (8.00%) 
Cystitis * 1  2/25 (8.00%) 
Gastroenteritis viral * 1  2/25 (8.00%) 
Pharyngitis * 1  2/25 (8.00%) 
Sinusitis * 1  2/25 (8.00%) 
Investigations   
Weight decreased * 1  2/25 (8.00%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  6/25 (24.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  5/25 (20.00%) 
Back pain * 1  6/25 (24.00%) 
Bone pain * 1  3/25 (12.00%) 
Myalgia * 1  8/25 (32.00%) 
Nervous system disorders   
Dizziness * 1  2/25 (8.00%) 
Dysgeusia * 1  4/25 (16.00%) 
Headache * 1  4/25 (16.00%) 
Paraesthesia * 1  3/25 (12.00%) 
Peripheral sensory neuropathy * 1  4/25 (16.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  7/25 (28.00%) 
Dyspnoea * 1  4/25 (16.00%) 
Epistaxis * 1  9/25 (36.00%) 
Oropharyngeal pain * 1  5/25 (20.00%) 
Skin and subcutaneous tissue disorders   
Acne * 1  2/25 (8.00%) 
Alopecia * 1  6/25 (24.00%) 
Dermatitis * 1  2/25 (8.00%) 
Hair colour changes * 1  2/25 (8.00%) 
Palmar-plantar erythrodysaesthesia syndrome * 1  6/25 (24.00%) 
Rash * 1  5/25 (20.00%) 
Skin discolouration * 1  2/25 (8.00%) 
Vascular disorders   
Hypertension * 1  6/25 (24.00%) 
Phlebitis * 1  2/25 (8.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.0
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00372424     History of Changes
Other Study ID Numbers: A6181113
First Submitted: September 5, 2006
First Posted: September 7, 2006
Results First Submitted: September 28, 2012
Results First Posted: October 30, 2012
Last Update Posted: December 28, 2012