Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01957579
Recruitment Status : Completed
First Posted : October 8, 2013
Results First Posted : April 10, 2017
Last Update Posted : June 12, 2017
Sponsor:
Collaborator:
MedImmune LLC
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Blood Cancer
Advanced B Cell Malignancies
Intervention Drug: MEDI-551
Enrollment 32
Recruitment Details First patient enrolled on 25 May 2011. Last patient last visit on 15 September 2015.
Pre-assignment Details A total of 32 patients were enrolled into the study. Twelve patients were screen failures, thus 20 patients received MEDI-551.
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description MEDI-551 2 mg/kg MEDI-551 4 mg/kg MEDI-551 8 mg/kg MEDI-551 12 mg/kg
Period Title: Overall Study
Started 3 7 4 6
Completed 3 6 2 6
Not Completed 0 1 2 0
Reason Not Completed
Withdrawal of concent             0             1             0             0
Death             0             0             2             0
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg Total
Hide Arm/Group Description MEDI-551 2mg/kg MEDI-551 4 mg/kg MEDI-551 8 mg/kg MEDI-551 12 mg/kg Total of all reporting groups
Overall Number of Baseline Participants 3 7 4 6 20
Hide Baseline Analysis Population Description
All patients who received at least 1 dose of MEDI-551.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 7 participants 4 participants 6 participants 20 participants
50.3  (8.1) 57.4  (10.5) 67.0  (8.7) 67.3  (11.4) 61.3  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 7 participants 4 participants 6 participants 20 participants
Female
2
  66.7%
5
  71.4%
0
   0.0%
3
  50.0%
10
  50.0%
Male
1
  33.3%
2
  28.6%
4
 100.0%
3
  50.0%
10
  50.0%
Disease Type   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 3 participants 7 participants 4 participants 6 participants 20 participants
CLL 1 0 0 1 2
DLBCL 0 2 2 2 6
FL 2 4 2 3 11
MM 0 1 0 0 1
[1]
Measure Description: Disease Type (CLL: chronic lymphocytic leukemia, DLBCL: diffuse large B-cell lymphoma, FL: follicular lymphoma, MM: multiple myeloma)
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame From baseline to 30 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All patients who received at least 1 dose of MEDI-551.
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description:
MEDI-551 2 mg/kg
MEDI-551 4 mg/kg
MEDI-551 8 mg/kg
MEDI-551 12 mg/kg
Overall Number of Participants Analyzed 3 7 4 6
Measure Type: Number
Unit of Measure: Participants
At least 1 Adverse Events (AE) 3 6 4 6
At least 1 AE of CTCAE Grade 3 or higher 2 2 1 3
At least 1 Serious Adverse Events (SAE) 1 0 0 0
2.Secondary Outcome
Title Number of Participants With Dose Limiting Toxicities
Hide Description A MEDI-551 treatment-related AE of any toxicity grade that lead to an inability to receive a full cycle (2 doses) of MEDI-551, or, any Grade 3 or higher toxicity that could not be reasonably ascribed to another cause, such as disease progression or accident.
Time Frame From baseline to 28 days after the first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the dose escalation phase who have received MEDI-551 at Day 1 and Day 8 and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description:
MEDI-551 2 mg/kg
MEDI-551 4 mg/kg
MEDI-551 8 mg/kg
MEDI-551 12 mg/kg
Overall Number of Participants Analyzed 3 6 3 6
Measure Type: Number
Unit of Measure: Participants
At least 1 Dose Limiting Toxicity 0 1 0 2
CTCAE Grade 3 or higher non-hematologic toxicity 0 1 0 1
CTCAE Grade 3 or higher hematologic toxicity 0 0 0 1
3.Secondary Outcome
Title Maximum Tolerated Dose
Hide Description A dose was considered non-tolerated and dose escalation stopped if ≥2 of up to 6 evaluable patients experienced a DLT at any dose level. MTD is the last dose level before the non-tolerated dose.
Time Frame From baseline to 28 days after the first dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the dose escalation phase who have received MEDI-551 at Day 1 and Day 8 and completed the safety follow-up through the dose-limiting toxicity (DLT) evaluation period (28 days), or who experienced a DLT.
Arm/Group Title MEDI-551
Hide Arm/Group Description:
MEDI-551 2, 4, 8 and 12 mg/kg were evaluated
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: mg/kg
8
4.Secondary Outcome
Title MEDI-551 Trough Concentration Levels at Day 0 (Pre-dose)
Hide Description Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Time Frame Day 0 (pre-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have trough concentration data at Day 0 (pre-dose)
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description:
MEDI-551 2 mg/kg
MEDI-551 4 mg/kg
MEDI-551 8 mg/kg
MEDI-551 12 mg/kg
Overall Number of Participants Analyzed 3 7 4 6
Mean (Standard Deviation)
Unit of Measure: μg/mL
NA [1]   (NA) NA [1]   (NA) NA [1]   (NA) NA [1]   (NA)
[1]
Below limit of quantification
5.Secondary Outcome
Title MEDI-551 Trough Concentration Levels at Day 7
Hide Description Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have trough concentration data at Day 7
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description:
MEDI-551 2 mg/kg
MEDI-551 4 mg/kg
MEDI-551 8 mg/kg
MEDI-551 12 mg/kg
Overall Number of Participants Analyzed 3 6 4 4
Mean (Standard Deviation)
Unit of Measure: μg/mL
21.3  (8.65) 39.2  (9.13) 91.9  (31.1) 104  (29.0)
6.Secondary Outcome
Title MEDI-551 Trough Concentration Levels at Day 28
Hide Description Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have trough concentration data at Day 28
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description:
MEDI-551 2 mg/kg
MEDI-551 4 mg/kg
MEDI-551 8 mg/kg
MEDI-551 12 mg/kg
Overall Number of Participants Analyzed 3 5 3 4
Mean (Standard Deviation)
Unit of Measure: μg/mL
23.2  (5.82) 36.2  (5.34) 103  (29.0) 115  (21.3)
7.Secondary Outcome
Title MEDI-551 Trough Concentration Levels at Day 56
Hide Description Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Time Frame Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have trough concentration data at Day 56
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description:
MEDI-551 2 mg/kg
MEDI-551 4 mg/kg
MEDI-551 8 mg/kg
MEDI-551 12 mg/kg
Overall Number of Participants Analyzed 3 5 3 4
Mean (Standard Deviation)
Unit of Measure: μg/mL
22.0  (4.92) 33.2  (6.92) 89.5  (13.9) 114  (33.1)
8.Secondary Outcome
Title MEDI-551 Trough Concentration Levels at Day84
Hide Description Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have trough concentration data at Day 84
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description:
MEDI-551 2 mg/kg
MEDI-551 4 mg/kg
MEDI-551 8 mg/kg
MEDI-551 12 mg/kg
Overall Number of Participants Analyzed 3 4 3 4
Mean (Standard Deviation)
Unit of Measure: μg/mL
21.7  (4.40) 33.7  (4.24) 91.6  (9.25) 103  (26.3)
9.Secondary Outcome
Title MEDI-551 Trough Concentration Levels at Day 112
Hide Description Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Time Frame Day 112
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have trough concentration data at Day 112
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description:
MEDI-551 2 mg/kg
MEDI-551 4 mg/kg
MEDI-551 8 mg/kg
MEDI-551 12 mg/kg
Overall Number of Participants Analyzed 3 4 2 4
Mean (Standard Deviation)
Unit of Measure: μg/mL
22.9  (3.10) 35.3  (5.07) 85.5 [1]   (NA) 114  (64.4)
[1]
Standard Deviation was calculated only if n>=3.
10.Secondary Outcome
Title MEDI-551 Trough Concentration Levels at Day 140
Hide Description Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Time Frame Day 140
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have trough concentration data at Day 140
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description:
MEDI-551 2 mg/kg
MEDI-551 4 mg/kg
MEDI-551 8 mg/kg
MEDI-551 12 mg/kg
Overall Number of Participants Analyzed 2 4 2 4
Mean (Standard Deviation)
Unit of Measure: μg/mL
22.1 [1]   (NA) 36.3  (10.5) 86.1 [1]   (NA) 117  (62.0)
[1]
Standard Deviation was calculated only if n>=3.
11.Secondary Outcome
Title MEDI-551 Trough Concentration Levels at Day 168
Hide Description Lower limit of quantification for MEDI-551 was 0.1 μg/mL.
Time Frame Day 168
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have trough concentration data at Day 168
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description:
MEDI-551 2 mg/kg
MEDI-551 4 mg/kg
MEDI-551 8 mg/kg
MEDI-551 12 mg/kg
Overall Number of Participants Analyzed 2 3 2 2
Mean (Standard Deviation)
Unit of Measure: μg/mL
20.0 [1]   (NA) 31.4  (8.30) 94.1 [1]   (NA) 82.1 [1]   (NA)
[1]
Standard Deviation was calculated only if n>=3.
12.Secondary Outcome
Title Anti-MEDI-551 Antibodies
Hide Description Only 1 patient was tested positive for ADA at pre-dose of Cycle 1 Day 1. However, it was considered as false-positive because the titer value was close to the cut point, and this patient was tested negative for ADA at all subsequent cycles post-baseline.
Time Frame From baseline to 30 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who have at least one post-baseline sample for Anti-MEDI-551 antibodies.
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description:
MEDI-551 2 mg/kg
MEDI-551 4 mg/kg
MEDI-551 8 mg/kg
MEDI-551 12 mg/kg
Overall Number of Participants Analyzed 3 7 4 6
Measure Type: Number
Unit of Measure: Participants
positive at least 1 time point 0 0 1 0
negative at all time points 3 7 3 6
13.Secondary Outcome
Title Number of Participants With Tumour Response in FL Patients
Hide Description

Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007).

CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.

PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified.

Time Frame From the baseline to 30 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with FL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.
Arm/Group Title 2 mg/kg (FL) 4 mg/kg (FL) 8 mg/kg (FL) 12 mg/kg (FL)
Hide Arm/Group Description:
FL patients in MEDI-551 2 mg/kg cohort
FL patients in MEDI-551 4 mg/kg cohort
FL patients in MEDI-551 8 mg/kg cohort
FL patients in MEDI-551 12 mg/kg cohort
Overall Number of Participants Analyzed 2 4 2 3
Measure Type: Number
Unit of Measure: Participants
2 3 2 2
14.Secondary Outcome
Title Number of Participants With Tumour Response in DLBCL Patients
Hide Description

Tumour response is defined as complete remission (CR) or partial remission (PR) (Cheson BD et al 2007).

CR: Nodal Masses: (a) FDG-avid or PET positive prior to therapy; mass of any size permitted if PET negative; (b) Variably FDG-avid or PET negative; regression to normal size on CT; Spleen, Liver: Not palpable, nodules disappeared. Bone Marrow: Infiltrate cleared on repeat biopsy; if indeterminate by morphology, immunohistochemistry should be negative.

PR: Nodal Masses: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses; no increase in size of other nodes; (a) FDG-avid or PET positive prior to therapy; ≥1 PET positive at previously involved site; (b) Variably FDG-avid or PET negative; regression on CT. Spleen, Liver: ≥50% decrease in SPD of nodules (for single nodule in greatest transverse diameter); no increase in size of liver or spleen. Bone Marrow: Irrelevant if positive prior to therapy; cell type should be specified.

Time Frame From the baseline to 30 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with DLBCL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.
Arm/Group Title 2 mg/kg (DLBCL) 4 mg/kg (DLBCL) 8 mg/kg (DLBCL) 12 mg/kg (DLBCL)
Hide Arm/Group Description:
DLBCL patients in MEDI-551 2 mg/kg cohort
DLBCL patients in MEDI-551 4 mg/kg cohort
DLBCL patients in MEDI-551 8 mg/kg cohort
DLBCL patients in MEDI-551 12 mg/kg cohort
Overall Number of Participants Analyzed 0 2 2 2
Measure Type: Number
Unit of Measure: Participants
0 1 2
15.Secondary Outcome
Title Number of Participants With Tumour Response in CLL Patients
Hide Description

Tumour response is defined as complete remission (CR) or partial remission (PR) (Hallek M et al 2008).

CR: all of the following criteria have to be met, and patients have to lack disease-related constitutional symptoms; Lymphadenopathy: None; Hepatomegaly: None; Splenomegaly: None; Blood lymphocytes: <4000/μL; Marrow: Normocellular, <30%lymphocytes, no B-lymphoid nodules, hypocellular marrow defines CR with incomplete marrow recovery; Platelet count: >100000/μL; Hemoglobin: >11.0 g/dL; Neutrophils: >1500/μL PR: at least 2 of the criteria of group A plus 1 of the criteria of group B have to be met.

Group A: Lymphadenopathy: Decrease ≥50%; Hepatomegaly: Decrease ≥50%; Splenomegaly: Decrease ≥50%; Blood lymphocytes: Decrease ≥50% from baseline; Marrow: 50% reduction in marrow infiltrate, or B-lymphoid nodules.

Group B: Platelet count: 100000/μL or increase ≥50% over baseline; Hemoglobin: >11.0 g/dL or increase ≥50% over baseline; Neutrophils: >1500/μL or >50% improvement over baseline.

Time Frame From the baseline to 30 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with CLL who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.
Arm/Group Title 2 mg/kg (CLL) 4 mg/kg (CLL) 8 mg/kg (CLL) 12 mg/kg (CLL)
Hide Arm/Group Description:
CLL patients in MEDI-551 2 mg/kg cohort
CLL patients in MEDI-551 4 mg/kg cohort
CLL patients in MEDI-551 8 mg/kg cohort
CLL patients in MEDI-551 12 mg/kg cohort
Overall Number of Participants Analyzed 1 0 0 1
Measure Type: Number
Unit of Measure: Participants
1 0
16.Secondary Outcome
Title Number of Participants With Tumour Response in MM Patients
Hide Description

Tumour response is defined as complete response (CR) or partial response (PR) (Durie M et al 2006).

CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas and 5% or less plasma cells in bone marrow PR: ≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200mg per 24 h. If the serum and urine M-protein are unmeasurable, a ≥50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. If serum and urine M-protein are unmeasurable, and serum free light assay is also unmeasurable, ≥50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was ≥30%. In addition to the above listed criteria, if present at baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is also required.

Time Frame From the baseline to30 days after the last dose of study drug
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with MM who received at least 1 dose of MEDI-551 and completed at least 1 post-baseline disease assessment.
Arm/Group Title 2 mg/kg (MM) 4 mg/kg (MM) 8 mg/kg (MM) 12 mg/kg (MM)
Hide Arm/Group Description:
MM patients in MEDI-551 2 mg/kg cohort
MM patients in MEDI-551 4 mg/kg cohort
MM patients in MEDI-551 8 mg/kg cohort
MM patients in MEDI-551 12 mg/kg cohort
Overall Number of Participants Analyzed 0 1 0 0
Measure Type: Number
Unit of Measure: Participants
0
Time Frame AEs were collected throughout the study, from informed consent until the end of 30 days after study treatment. The follow-up period is defined as 3 months after study treatment is discontinued.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Hide Arm/Group Description MEDI-551 2mg/kg MEDI-551 4 mg/kg MEDI-551 8 mg/kg MEDI-551 12 mg/kg
All-Cause Mortality
2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)   0/7 (0.00%)   0/4 (0.00%)   0/6 (0.00%) 
Infections and infestations         
Epiglottitis * 1  1/3 (33.33%)  0/7 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
2 mg/kg 4 mg/kg 8 mg/kg 12 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   6/7 (85.71%)   4/4 (100.00%)   6/6 (100.00%) 
Blood and lymphatic system disorders         
Leukopenia * 1  0/3 (0.00%)  1/7 (14.29%)  1/4 (25.00%)  1/6 (16.67%) 
Neutropenia * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  1/6 (16.67%) 
Febrile neutropenia * 1  0/3 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Lymphadenitis * 1  1/3 (33.33%)  0/7 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Eye disorders         
Conjunctivitis allergic * 1  0/3 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Eyelid oedema * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
Gastrointestinal disorders         
Constipation * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  1/6 (16.67%) 
Abdominal pain upper * 1  0/3 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Diarrhoea * 1  0/3 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Dry mouth * 1  0/3 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Proctalgia * 1  0/3 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Stomatitis * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
General disorders         
Fatigue * 1  1/3 (33.33%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
Influenza like illness * 1  1/3 (33.33%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
Pyrexia * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
Hepatobiliary disorders         
Hepatic function abnormal * 1  0/3 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Infections and infestations         
Nasopharyngitis * 1  1/3 (33.33%)  0/7 (0.00%)  1/4 (25.00%)  1/6 (16.67%) 
Upper respiratory tract infection * 1  1/3 (33.33%)  0/7 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Bronchitis * 1  0/3 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Oral candidiasis * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
Injury, poisoning and procedural complications         
Infusion related reaction * 1  2/3 (66.67%)  1/7 (14.29%)  3/4 (75.00%)  3/6 (50.00%) 
Investigations         
White blood cell count decreased * 1  2/3 (66.67%)  2/7 (28.57%)  0/4 (0.00%)  0/6 (0.00%) 
Lymphocyte count decreased * 1  1/3 (33.33%)  2/7 (28.57%)  0/4 (0.00%)  0/6 (0.00%) 
Neutrophil count decreased * 1  1/3 (33.33%)  2/7 (28.57%)  0/4 (0.00%)  0/6 (0.00%) 
Platelet count decreased * 1  0/3 (0.00%)  1/7 (14.29%)  1/4 (25.00%)  0/6 (0.00%) 
Aspartate aminotransferase increased * 1  1/3 (33.33%)  0/7 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Blood cholesterol increased * 1  0/3 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Blood creatine phosphokinase increased * 1  0/3 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Blood creatinine increased * 1  0/3 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Blood lactate dehydrogenase increased * 1  1/3 (33.33%)  0/7 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Blood triglycerides increased * 1  1/3 (33.33%)  0/7 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Metabolism and nutrition disorders         
Hypertriglyceridaemia * 1  1/3 (33.33%)  1/7 (14.29%)  4/4 (100.00%)  0/6 (0.00%) 
Musculoskeletal and connective tissue disorders         
Monarthritis * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
Myalgia * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
Spinal osteoarthritis * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
Musculoskeletal chest pain * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
Musculoskeletal stiffness * 1  0/3 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Cholesteatoma * 1  0/3 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Sebaceous adenoma * 1  0/3 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Nervous system disorders         
Headache * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
Peripheral sensory neuropathy * 1  0/3 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Psychiatric disorders         
Insomnia * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  1/6 (16.67%) 
Renal and urinary disorders         
Calculus ureteric * 1  1/3 (33.33%)  0/7 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Haematuria * 1  1/3 (33.33%)  0/7 (0.00%)  0/4 (0.00%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
Upper respiratory tract inflammation * 1  0/3 (0.00%)  0/7 (0.00%)  0/4 (0.00%)  1/6 (16.67%) 
Skin and subcutaneous tissue disorders         
Rash * 1  1/3 (33.33%)  2/7 (28.57%)  0/4 (0.00%)  0/6 (0.00%) 
Drug eruption * 1  0/3 (0.00%)  0/7 (0.00%)  1/4 (25.00%)  0/6 (0.00%) 
Eczema * 1  0/3 (0.00%)  1/7 (14.29%)  0/4 (0.00%)  0/6 (0.00%) 
Vascular disorders         
Hypertension * 1  0/3 (0.00%)  2/7 (28.57%)  0/4 (0.00%)  0/6 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: MedImmune, LLC
EMail: ClinicalTrialTransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01957579     History of Changes
Obsolete Identifiers: NCT01377116
Other Study ID Numbers: D2850C00001
First Submitted: October 1, 2013
First Posted: October 8, 2013
Results First Submitted: February 27, 2017
Results First Posted: April 10, 2017
Last Update Posted: June 12, 2017