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Study to Assess the Safety of AZD1480 in Patients With Myeloproliferative Diseases

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ClinicalTrials.gov Identifier: NCT00910728
Recruitment Status : Completed
First Posted : June 1, 2009
Results First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Sponsor:
Collaborators:
University of Texas
New York City Hoffman Center
Gustave Roussy, Cancer Campus, Grand Paris
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Conditions Primary Myelofibrosis (PMF)
Post-Polycythaemia Vera
Essential Thrombocythaemia Myelofibrosis
Intervention Drug: AZD1480
Enrollment 65
Recruitment Details Commenced 19MAY2009. All subjects recruited to Part A only (based on emerging data). 65 patients were enrolled of which 35 recieved at least 1 dose of AZD1480.
Pre-assignment Details Patients ≥25 years of age with primary myelofibrosis (MF) and post-polycythaemia vera/essential thrombocythaemia MF who had relapsed, were intolerant of, or were refractory to MF-directed therapy were enrolled.
Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 50 mg QD 70 mg QD 10 mg BID 15 mg BID 20 mg QD
Hide Arm/Group Description AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules
Period Title: Overall Study
Started 6 3 3 3 6 1 6 4 3
Completed 0 0 0 0 1 0 0 1 0
Not Completed 6 3 3 3 5 1 6 3 3
Reason Not Completed
Lack of Efficacy             2             3             1             2             1             0             2             2             2
Withdrawal by Subject             0             0             0             0             3             1             2             0             0
(not specified)             2             0             1             0             1             0             0             0             0
Adverse Event             2             0             1             1             0             0             2             1             1
Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 70 mg QD 15 mg BID 30 mg QD 50 mg QD 10 mg BID 20 mg QD Total
Hide Arm/Group Description AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules Total of all reporting groups
Overall Number of Baseline Participants 6 3 3 1 4 3 6 6 3 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 3 participants 3 participants 1 participants 4 participants 3 participants 6 participants 6 participants 3 participants 35 participants
57.5  (7.7) 66.3  (9.6) 76.7  (10.5) 56.0  (0) 66.5  (10.3) 49.3  (4.2) 69.3  (3.8) 65.3  (11.3) 75.7  (3.8) 65.1  (10.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 3 participants 1 participants 4 participants 3 participants 6 participants 6 participants 3 participants 35 participants
Female
1
  16.7%
1
  33.3%
1
  33.3%
1
 100.0%
0
   0.0%
1
  33.3%
5
  83.3%
2
  33.3%
2
  66.7%
14
  40.0%
Male
5
  83.3%
2
  66.7%
2
  66.7%
0
   0.0%
4
 100.0%
2
  66.7%
1
  16.7%
4
  66.7%
1
  33.3%
21
  60.0%
1.Primary Outcome
Title Pharmacokinetic Parameters Following Single Dosing: AUC0-12
Hide Description Single dose AUC0-12 (ug*h/L)
Time Frame 0 to 12 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8 and 12 hours post dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 70 mg QD 10 mg BID 15 mg BID 50 mg QD 20 mg QD
Hide Arm/Group Description:
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
Overall Number of Participants Analyzed 6 3 3 3 1 6 4 6 3
Geometric Mean (Standard Deviation)
Unit of Measure: ug*h/L
69.2  (27.5) 295  (68.2) 278  (257) 1860  (546) 5800  (0) 425  (190) 497  (191) 3090  (2060) 472  (257)
2.Primary Outcome
Title Pharmacokinetic Parameters Following Single Dosing: AUC0-24
Hide Description Single dose AUC0-24 (ug*h/L)
Time Frame 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

From the BID schedule we can not derive the single dosing AUC0_24 and hence this is not presented/calculated.

Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 70 mg QD 10 mg BID 15 mg BID 50 mg QD 20 mg QD
Hide Arm/Group Description:
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
Overall Number of Participants Analyzed 6 3 3 3 1 0 0 6 3
Geometric Mean (Standard Deviation)
Unit of Measure: ug*h/L
70.2  (28.7) 308  (76) 285  (252) 2000  (624) 6260  (0) 3540  (2570) 508  (280)
3.Primary Outcome
Title Pharmacokinetic Parameters Following Single Dosing:AUC0-inf
Hide Description Single dose AUC(0 to infinity) (ug*h/L)
Time Frame 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

From the BID (twice a day dosing schedules) we can not derive the PK parameter AUC0_inf following single dosing. With that these do not contribute.

Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 70 mg QD 10 mg BID 15 mg BID 50 mg QD 20 mg QD
Hide Arm/Group Description:
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
Overall Number of Participants Analyzed 6 3 3 3 1 0 0 6 3
Geometric Mean (Standard Deviation)
Unit of Measure: ug*h/L
83.5  (36.6) 312  (79.5) 378  (290) 2040  (657) 6300  (0) 3650  (2980) 517  (294)
4.Primary Outcome
Title Pharmacokinetic Parameters Following Multiple Dosing: Cmax,ss
Hide Description Multiple dose Cmax,ss (ug/L)
Time Frame On Days 1 and 28 at 0, 0,5, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose, and at 0, 2, 4 hours post dose on Days 4 and 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 70 mg QD 10 mg BID 15 mg BID 50 mg QD 20 mg QD
Hide Arm/Group Description:
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
Overall Number of Participants Analyzed 5 3 3 3 1 5 4 5 3
Geometric Mean (Standard Deviation)
Unit of Measure: ug/L
51.3  (18) 134  (36.3) 176  (179) 658  (265) 1500  (0) 218  (72.3) 334  (68.2) 924  (461) 241  (346)
5.Primary Outcome
Title Pharmacokinetic Parameters Following Multiple Dosing: Cmin,ss
Hide Description Multiple dose Cmin,ss (ug/L)
Time Frame On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post-dose and at 0, 2, 4 hours post-dose on Days 4 and 10.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 70 mg QD 10 mg BID 15 mg BID 50 mg QD 20 mg QD
Hide Arm/Group Description:
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
Overall Number of Participants Analyzed 6 3 3 3 1 6 4 6 3
Geometric Mean (Standard Deviation)
Unit of Measure: ug/L
69.2  (27.5) 295  (68.2) 278  (257) 1860  (546) 5800  (0) 425  (190) 497  (191) 3090  (2060) 472  (257)
6.Primary Outcome
Title Pharmacokinetic Parameters Following Single Dosing: Cmax
Hide Description Single dose Cmax (ug/L)
Time Frame 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 70 mg QD 10 mg BID 15 mg BID 50 mg QD 20 mg QD
Hide Arm/Group Description:
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
Overall Number of Participants Analyzed 6 3 3 3 1 6 4 6 3
Geometric Mean (Standard Deviation)
Unit of Measure: ug/L
69.9  (32.7) 133  (54.7) 157  (145) 739  (307) 2600  (0) 273  (62.2) 324  (79.5) 1320  (379) 268  (227)
7.Primary Outcome
Title Pharmacokinetic Parameters Following Single Dosing: Vz/F
Hide Description Single dose Vz/F (L)
Time Frame 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

Due to the nature of the dosing schedule this PK parameter was not reported for the BID (twice daily dosing) groups.

Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 70 mg QD 10 mg BID 15 mg BID 50 mg QD 20 mg QD
Hide Arm/Group Description:
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
Overall Number of Participants Analyzed 6 3 3 3 1 0 0 6 3
Geometric Mean (Standard Deviation)
Unit of Measure: L
222  (125) 108  (28.1) 138  (161) 97  (15) 57.9  (0) 105  (82.2) 284  (92.3)
8.Primary Outcome
Title Pharmacokinetic Parameters Following Single Dosing: CL/F
Hide Description Single dose CL/F (L/h)
Time Frame 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 70 mg QD 10 mg BID 15 mg BID 50 mg QD 20 mg QD
Hide Arm/Group Description:
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
Overall Number of Participants Analyzed 6 3 3 3 1 6 4 6 3
Geometric Mean (Standard Deviation)
Unit of Measure: L/h
35.2  (13.9) 16  (4.25) 34.8  (22.5) 14.7  (5.52) 11.1  (0) 22.6  (9.05) 29.7  (13) 13.8  (8.5) 38.7  (16.7)
9.Primary Outcome
Title Pharmacokinetic Parameters Following Multiple Dosing: CLss/F
Hide Description Multiple dose CLss/F (L/h)
Time Frame On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description

Pharmacokinetic.

Note - no GeoCV(%) was captured in the TFL. Hence the geometric mean was still presented as applicable but with the SD (since only available).

Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 70 mg QD 10 mg BID 15 mg BID 50 mg QD 20 mg QD
Hide Arm/Group Description:
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
Overall Number of Participants Analyzed 5 3 3 3 1 5 4 6 3
Geometric Mean (Standard Deviation)
Unit of Measure: L/h
37.8  (6) 15.8  (4.4) 30.1  (21.7) 17  (5.26) 9.57  (0) 20  (6.91) 20.4  (13.8) 16  (8.94) 20.8  (21)
10.Primary Outcome
Title Pharamcokinetic Parameters Following Single Dosing: Tmax
Hide Description Single dose Tmax (h)
Time Frame 0 to 24 hour sampling (Day 1: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 70 mg QD 10 mg BID 15 mg BID 50 mg QD 20 mg QD
Hide Arm/Group Description:
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
Overall Number of Participants Analyzed 6 3 3 3 1 6 4 6 3
Median (Full Range)
Unit of Measure: h
0.625
(0.5 to 1.5)
0.75
(0.5 to 2)
0.75
(0.5 to 0.75)
1
(1 to 1.5)
0.75
(0.75 to 0.75)
0.625
(0.5 to 1)
0.875
(0.5 to 1)
0.89
(0.75 to 1.5)
0.75
(0.5 to 1.03)
11.Primary Outcome
Title Pharamcokinetic Parameters Following Multiple Dosing: Tmax,ss
Hide Description Multiple dose Tmax,ss (h)
Time Frame On Days 1 and 28 at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose and at 0, 2, 4 hours post-dose on Days 4 and 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 70 mg QD 10 mg BID 15 mg BID 50 mg QD 20 mg QD
Hide Arm/Group Description:
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
Overall Number of Participants Analyzed 6 3 3 3 1 6 4 6 3
Median (Full Range)
Unit of Measure: h
0.5
(0.5 to 1)
0.78
(0.75 to 1)
0.77
(0.75 to 1)
0.75
(0.52 to 1)
1.5
(1.5 to 1.5)
1
(0.5 to 1.5)
0.875
(0.75 to 1.5)
0.78
(0.25 to 2.25)
1
(0.75 to 3)
12.Primary Outcome
Title Inhibition of PSTAT3 (Count)
Hide Description PSTAT3 inhinition
Time Frame 2hrs and 4 hrs post dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 30 mg QD 70 mg QD 10 mg BID 15 mg BID 50 mg QD 20 mg QD
Hide Arm/Group Description:
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
AZD1480 may be administered orally in capsules
Overall Number of Participants Analyzed 6 3 3 3 1 6 4 6 3
Measure Type: Number
Unit of Measure: # patients with 50% reduction in PSTAT3
2 Hours post dose 0 0 0 1 0 0 0 3 0
4 Hours post dose 0 0 0 0 0 1 0 0 0
Time Frame Throughout study continuously and 30 days post discontinuation of treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2.5 mg QD 5.0 mg QD 10 mg QD 70 mg QD 15 mg BID 20 mg QD 30 mg QD 50 mg QD 10 mg BID
Hide Arm/Group Description AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules AZD1480 may be administered orally in capsules
All-Cause Mortality
2.5 mg QD 5.0 mg QD 10 mg QD 70 mg QD 15 mg BID 20 mg QD 30 mg QD 50 mg QD 10 mg BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
2.5 mg QD 5.0 mg QD 10 mg QD 70 mg QD 15 mg BID 20 mg QD 30 mg QD 50 mg QD 10 mg BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      2/3 (66.67%)      0/3 (0.00%)      0/1 (0.00%)      1/4 (25.00%)      3/3 (100.00%)      0/3 (0.00%)      4/6 (66.67%)      3/6 (50.00%)    
Blood and lymphatic system disorders                   
ANAEMIA   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
NEUTROPENIA   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
SPLENIC INFARCTION   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Cardiac disorders                   
ATRIAL FLUTTER/FIBRILLATION   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
CARDIAC FAILURE CHRONIC   0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
CORONARY ARTERY DISEASE   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
TACHYCARDIA   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
General disorders                   
PYREXIA   1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Infections and infestations                   
PNEUMONIA   1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications                   
CRANIOCEREBRAL INJURY   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
UPPER LIMB FRACTURE   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Investigations                   
HAEMOGLOBIN DECREASED   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Metabolism and nutrition disorders                   
DEHYDRATION   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
GOUT   0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                   
BASAL CELL CARCINOMA   0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders                   
APHASIA   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
AMNESIA   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
ATAXIA   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
DYSARTHRIA   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Psychiatric disorders                   
CONFUSIONAL STATE   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
2.5 mg QD 5.0 mg QD 10 mg QD 70 mg QD 15 mg BID 20 mg QD 30 mg QD 50 mg QD 10 mg BID
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      1/1 (100.00%)      4/4 (100.00%)      3/3 (100.00%)      3/3 (100.00%)      6/6 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders                   
ANAEMIA   1/6 (16.67%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 4/6 (66.67%)  4 1/6 (16.67%)  1
NEUTROPENIUA   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/6 (0.00%)  0 1/6 (16.67%)  1
THROMBOCYTOPENIA   1/6 (16.67%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
Eye disorders                   
RETINAL HAEMORRHAGE   1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
CATARAC   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 2/6 (33.33%)  2
CONJUNCTIVAL HAEMORRHAGE   0/6 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
DRY EYE   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 3/6 (50.00%)  3 3/6 (50.00%)  3
HAEMORRHAGE   0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
KERATITI   0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1
Gastrointestinal disorders                   
DIARRHOEA   0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1
VOMITING   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
ASCITES   1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
ABDOMINAL DISTENSION   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
ABDOMINAL PAIN   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  2 2/6 (33.33%)  2 0/6 (0.00%)  0
CONSTIPATION   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
GASTROOESOPHAGEAL REFLUX DISEASE   0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
HAEMORRHOIDS   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0
NAUSEA   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
General disorders                   
FATIGUE   1/6 (16.67%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
ASTHENIA   2/6 (33.33%)  2 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 2/3 (66.67%)  2 1/3 (33.33%)  1 1/6 (16.67%)  1 4/6 (66.67%)  4
MUCOSAL INFLAMMATION   0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1
PYREXIA   2/6 (33.33%)  2 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
HYPERTHERMIA   1/6 (16.67%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
OEMEMA PERIPHERAL   1/6 (16.67%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 1/1 (100.00%)  1 2/4 (50.00%)  2 2/3 (66.67%)  2 0/3 (0.00%)  0 2/6 (33.33%)  2 3/6 (50.00%)  3
OEDEMA   0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/1 (100.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Hepatobiliary disorders                   
HYPERBILIRUBINAEMIA   0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Infections and infestations                   
FOLLICULITIS   0/6 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Injury, poisoning and procedural complications                   
EXCORIATION   0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Investigations                   
WEIGHT INCREASE   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
CARDIAC MURMUR   0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders                   
MUSCLE SPASMS   1/6 (16.67%)  1 1/3 (33.33%)  1 2/3 (66.67%)  2 0/1 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 0/6 (0.00%)  0 2/6 (33.33%)  2
BONE PAIN   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 1/6 (16.67%)  1 1/6 (16.67%)  1
MUSCULOSKELETAL PAIN   0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
MYALGIA AGGRAVATED   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
PAIN   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Nervous system disorders                   
DIZZINESS   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/1 (100.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 2/3 (66.67%)  2 3/6 (50.00%)  3 1/6 (16.67%)  1
HEADACHE   0/6 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/1 (100.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 1/6 (16.67%)  1
PARAESTHES   0/6 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
Psychiatric disorders                   
CONFUSIONAL STATE   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
INSOMNIA   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Renal and urinary disorders                   
PROTEINURIA   3/6 (50.00%)  3 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
HAEMATURIA   0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
Respiratory, thoracic and mediastinal disorders                   
DYSPNOEA   0/6 (0.00%)  0 1/1 (100.00%)  1 1/1 (100.00%)  1 0/0  0 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 2/2 (100.00%)  2
EPITAXIS   1/6 (16.67%)  1 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Skin and subcutaneous tissue disorders                   
ECCHYMOSI   0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0
PETECHIAE   0/6 (0.00%)  0 1/3 (33.33%)  1 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
PRURITIS   0/6 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1 0/1 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
RASH   0/6 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0 0/1 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 1/3 (33.33%)  1 1/6 (16.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
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: Dr Gregory Curt, MD
Organization: AstraZeneca
Phone: +1 301 398 0109
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00910728     History of Changes
Other Study ID Numbers: D1060C00001
First Submitted: May 28, 2009
First Posted: June 1, 2009
Results First Submitted: August 18, 2015
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017