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Study is Designed to Assess the Safety and Tolerability of AZD4547 at Increasing Doses in Patients With Advanced Tumours

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: NCT00979134
Recruitment Status : Terminated (

Termination of study enrolment to Part C, Cohort 3 (08 July 2013) was based on the analysis of data from Study D2610C00004.

Data were available from 33 patient

)
First Posted : September 17, 2009
Results First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cancer
Advanced Solid Malignancies
Intervention Drug: AZD4547
Enrollment 95
Recruitment Details First patient enrolled: 21 October 2009 and last patient enrolled: 13 December 2013. This was a multicentre study conducted at a total of 29 centres in 7 countries.
Pre-assignment Details In Parts A and B, a single dose was followed by a Washout Period of 5 to 10 days before multiple dosing commenced.
Arm/Group Title Part A Part B Part C
Hide Arm/Group Description Dose escalation Dose expansion phase (80mg bd tablet) Dose expansion in patients with FGFR gene-amplified tumours
Period Title: Overall Study
Started 43 6 45
Completed 10 [1] 0 [1] 5 [1]
Not Completed 33 6 40
Reason Not Completed
Disease progression             18             2             5
Adverse Event             0             0             2
Withdrawal by Subject             1             1             2
Lost to Follow-up             2             2             0
Death             4             0             26
Other             8             1             5
[1]
At DCO
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio < 2 ) Part A Total
Hide Arm/Group Description Dose expansion phase (80mg bd tablet) Dose expansion in patients with FGFR gene-amplified tumours Dose expansion in patients with FGFR gene-amplified tumours Dose escalation Total of all reporting groups
Overall Number of Baseline Participants 6 33 12 43 94
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 33 participants 12 participants 43 participants 94 participants
58.7  (8.1) 59.5  (10.82) 58.2  (11.77) 55.8  (10.1) 57.59  (10.57)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 33 participants 12 participants 43 participants 94 participants
Female
3
  50.0%
16
  48.5%
3
  25.0%
18
  41.9%
40
  42.6%
Male
3
  50.0%
17
  51.5%
9
  75.0%
25
  58.1%
54
  57.4%
1.Primary Outcome
Title Number of Patients Who Experienced at Least 1 AE
Hide Description To investigate the safety and tolerability of AZD4547. System organ class (SOC), preferred term (PT), duration and severity all recorded.
Time Frame AEs are monitored from screenng through to 30 day follow up period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio <2) Part A
Hide Arm/Group Description:
Dose expansion phase (80mg bd tablet)
Dose expansion in patients with FGFR gene-amplified tumours
Dose expansion in patients with FGFR gene-amplified tumours
Dose escalation
Overall Number of Participants Analyzed 6 33 12 43
Measure Type: Number
Unit of Measure: Participants
6 33 12 43
2.Primary Outcome
Title Number of Participants Who Experienced at Least 1 Causally Related AE.
Hide Description To investigate the safety and tolerability of AZD4547. A causally related AE is an AE deemed to be causally related to AZD4547.
Time Frame AEs are continually assessed from screening up to 30 day FU period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio <2) Part A
Hide Arm/Group Description:
Dose expansion phase (80mg bd tablet)
Dose expansion in patients with FGFR gene-amplified tumours
Dose expansion in patients with FGFR gene-amplified tumours
Dose escalation
Overall Number of Participants Analyzed 6 33 12 43
Measure Type: Number
Unit of Measure: Participants
6 31 10 42
3.Primary Outcome
Title Number of Participants With at Least 1 AE of CTCAE >=G3
Hide Description To investigate the safety and tolerability of AZD4547
Time Frame Ongoing up to discontinuation up to 30 day FU.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio <2) Part A
Hide Arm/Group Description:
Dose expansion phase (80mg bd tablet)
Dose expansion in patients with FGFR gene-amplified tumours
Dose expansion in patients with FGFR gene-amplified tumours
Dose escalation
Overall Number of Participants Analyzed 6 33 12 43
Measure Type: Number
Unit of Measure: Participants
1 16 5 17
4.Primary Outcome
Title Number of Participants With at Least 1 Causally Related AE of CTCAE >=G3
Hide Description To investigate the safety and tolerability of AZD4547
Time Frame Ongoing up to discontinuation up to 30 day FU.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio <2) Part A
Hide Arm/Group Description:
Dose expansion phase (80mg bd tablet)
Dose expansion in patients with FGFR gene-amplified tumours
Dose expansion in patients with FGFR gene-amplified tumours
Dose escalation
Overall Number of Participants Analyzed 6 33 12 43
Measure Type: Number
Unit of Measure: Participants
0 8 3 12
5.Primary Outcome
Title Number of Participants Who Experienced at Least One SAE
Hide Description To investigate the safety and tolerability of AZD4547. A SAE (Serious Adverse Event) is and AE (adverse Event) which fulfills one of the following criteria that the PI assesses closely such as results in death, immediately life-threatening, requires hospitalisation or prolongation of, results in significant disability, results in birth defect, may jepardise the patient or require intervention to prevent any of the previous outcomes.
Time Frame Serious Adverse Events (SAEs) are continually assessed from Screening up to the end of the 30 day FU period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio <2) Part A
Hide Arm/Group Description:
Dose expansion phase (80mg bd tablet)
Dose expansion in patients with FGFR gene-amplified tumours
Dose expansion in patients with FGFR gene-amplified tumours
Dose escalation
Overall Number of Participants Analyzed 6 33 12 43
Measure Type: Number
Unit of Measure: Number of participants
1 10 3 11
6.Primary Outcome
Title Number of Participants With at Least 1 Causally Related SAE
Hide Description To investigate the safety and tolerability of AZD4547: SAEs are assessed and deemed as causally related or not to AZD4547
Time Frame SAEs are continually monitored from screening to end of 30 FU period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio <2) Part A
Hide Arm/Group Description:
Dose expansion phase (80mg bd tablet)
Dose expansion in patients with FGFR gene-amplified tumours
Dose expansion in patients with FGFR gene-amplified tumours
Dose escalation
Overall Number of Participants Analyzed 6 33 12 43
Measure Type: Number
Unit of Measure: Number of participants
1 5 0 5
7.Secondary Outcome
Title AUC(0-infinity)
Hide Description To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
Time Frame PK samples out to 96 hours "0 to 96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
PK
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio < 2) Part A
Hide Arm/Group Description:
Dose expansion phase (80mg bd tablet)
Dose expansion in patients with FGFR gene-amplified tumours
Dose expansion in patients with FGFR gene-amplified tumours
Dose escalation
Overall Number of Participants Analyzed 6 0 0 42
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
1818
(59.43%)
2697
(110.8%)
8.Secondary Outcome
Title Tumour Response (Best Objective Response) - Number of Patients With a Confirmed Response of Partial Response (PR) or Confirmed Response (CR)
Hide Description To obtain a preliminary assessment of the anti tumour activity of AZD4547 by evaluation of tumour response using Response Evaluation Criteria in Solid Tumours (RECIST) criteria version 1.1. Objective response = CR + PR; CR=disappearance of all target lesions and PR is >=30% reduction in sum of longest diameter of target lesions
Time Frame Baseline assessment, then assessment every 6 weeks after start of treatment until objective disease progression.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy/Tumour response: All dosed patients meeting the final FISH 6 score criteria with a baseline tumour assessment and had a FGFR1 FISH ratio ≥2 if the patient was from Part C
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part A Part C (FISH Ratio < 2)
Hide Arm/Group Description:
Dose expansion phase (80mg bd tablet)
Dose expansion in patients with FGFR gene-amplified tumours
Dose escalation
Dose expansion in patients with FGFR gene-amplified tumours
Overall Number of Participants Analyzed 6 33 43 12
Measure Type: Number
Unit of Measure: Patients
0 1 0 0
9.Secondary Outcome
Title Cmax (ng/mL)
Hide Description To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
Time Frame PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
PK
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part A Part C (FISH Ratio < 2)
Hide Arm/Group Description:
Dose expansion phase (80mg bd tablet)
Dose expansion in patients with FGFR gene-amplified tumours
Dose escalation
Dose expansion in patients with FGFR gene-amplified tumours
Overall Number of Participants Analyzed 6 0 43 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
112.0
(81.47%)
167.4
(112.1%)
10.Secondary Outcome
Title Css,Max (ng/mL)
Hide Description To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
Time Frame PK samples out to 96 hours "0-96 hours post-dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
PK
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part A Part C (FISH Ratio < 2)
Hide Arm/Group Description:
Dose expansion phase (80mg bd tablet)
Dose expansion in patients with FGFR gene-amplified tumours
Dose escalation
Dose expansion in patients with FGFR gene-amplified tumours
Overall Number of Participants Analyzed 6 0 32 0
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
289.3
(45.98%)
297.1
(123.5%)
11.Secondary Outcome
Title AUC,ss(0-infinity)
Hide Description To characterise the pharmacokinetics (PK) of AZD4547 following a single administration and at steady state after dosing when given orally.
Time Frame PK samples out to 96 hours "0-96 hours post dose" after single dose (in parts A & B only). Steady state PK profile 3 weeks after the start of BD dosing.
Hide Outcome Measure Data
Hide Analysis Population Description
PK
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio < 2) Part A
Hide Arm/Group Description:
Dose expansion phase (80mg bd tablet)
Dose expansion in patients with FGFR gene-amplified tumours
Dose expansion in patients with FGFR gene-amplified tumours
Dose escalation
Overall Number of Participants Analyzed 4 0 0 31
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
2606
(41.32%)
2337
(125.2%)
Time Frame AEs were collected on a continual basis from Screening up until the end of the 28 day follow up period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio < 2) Part A
Hide Arm/Group Description Dose expansion phase (80mg bd tablet) Dose expansion in patients with FGFR gene-amplified tumours Dose expansionj in patients with FGFR gene-amplified tumours Dose escalation
All-Cause Mortality
Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio < 2) Part A
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Hide Serious Adverse Events
Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio < 2) Part A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      10/33 (30.30%)      3/12 (25.00%)      11/43 (25.58%)    
Blood and lymphatic system disorders         
Anaemia  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  1/43 (2.33%)  1
Pericardial effusion  1  0/6 (0.00%)  1/33 (3.03%)  1 0/12 (0.00%)  0/43 (0.00%) 
Eye disorders         
Retinal detachment  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  1/43 (2.33%)  1
Chorioretinopathy  1  0/6 (0.00%)  2/33 (6.06%)  2 0/12 (0.00%)  0/43 (0.00%) 
Gastrointestinal disorders         
Decreased appetite  1  0/6 (0.00%)  1/33 (3.03%)  1 0/12 (0.00%)  0/43 (0.00%) 
Vomiting  1  0/6 (0.00%)  1/33 (3.03%)  1 0/12 (0.00%)  1/43 (2.33%)  1
General disorders         
Pyrexia  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  1/43 (2.33%)  1
Tumour associated fever  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  1/43 (2.33%)  1
General physical health deterioration  1  0/6 (0.00%)  2/33 (6.06%)  2 1/12 (8.33%)  1 0/43 (0.00%) 
Asthenia  1  0/6 (0.00%)  1/33 (3.03%)  1 1/12 (8.33%)  1 0/43 (0.00%) 
Hepatobiliary disorders         
Bile duct obstruction  1  0/6 (0.00%)  1/33 (3.03%)  1 0/12 (0.00%)  0/43 (0.00%) 
Infections and infestations         
Pneumonia  1  0/6 (0.00%)  0/33 (0.00%)  1/12 (8.33%)  1 0/43 (0.00%) 
Sepsis  1  0/6 (0.00%)  1/33 (3.03%)  1 0/12 (0.00%)  1/43 (2.33%)  1
Investigations         
ALT increased  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  1/43 (2.33%)  1
GGT increased  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  1/43 (2.33%)  1
Blood creatinine increased  1  1/6 (16.67%)  1 0/33 (0.00%)  0/12 (0.00%)  0/43 (0.00%) 
Metabolism and nutrition disorders         
Dehydration  1  0/6 (0.00%)  2/33 (6.06%)  2 0/12 (0.00%)  0/43 (0.00%) 
Hyponatraemia  1  0/6 (0.00%)  1/33 (3.03%)  1 0/12 (0.00%)  0/43 (0.00%) 
Nervous system disorders         
Epilepsy  1  0/6 (0.00%)  1/33 (3.03%)  1 0/12 (0.00%)  0/43 (0.00%) 
Hypotension  1  0/6 (0.00%)  0/33 (0.00%)  1/12 (8.33%)  1 0/43 (0.00%) 
Psychiatric disorders         
Delirium  1  0/6 (0.00%)  0/33 (0.00%)  1/12 (8.33%)  1 0/43 (0.00%) 
Renal and urinary disorders         
Renal failure  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  4/43 (9.30%)  4
Hydronephrosis  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  1/43 (2.33%)  1
Nephrolithiasis  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  1/43 (2.33%)  1
Pelvi-ureteric obstruction  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  1/43 (2.33%)  1
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  0/6 (0.00%)  2/33 (6.06%)  2 0/12 (0.00%)  1/43 (2.33%)  1
Lung disorder  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  1/43 (2.33%)  1
Hypoxia  1  0/6 (0.00%)  1/33 (3.03%)  1 0/12 (0.00%)  0/43 (0.00%) 
Pleural effusion  1  0/6 (0.00%)  1/33 (3.03%)  1 0/12 (0.00%)  0/43 (0.00%) 
Respiratory failure  1  0/6 (0.00%)  1/33 (3.03%)  1 0/12 (0.00%)  0/43 (0.00%) 
Social circumstances         
Euthanasia  1  0/6 (0.00%)  1/33 (3.03%)  1 0/12 (0.00%)  0/43 (0.00%) 
Vascular disorders         
Atrial flutter  1  0/6 (0.00%)  0/33 (0.00%)  1/12 (8.33%)  1 0/43 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.1.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part B Part C (FISH Ratio >= 2) Part C (FISH Ratio < 2) Part A
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      33/33 (100.00%)      12/12 (100.00%)      43/43 (100.00%)    
Blood and lymphatic system disorders         
Anaemia  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  4/43 (9.30%)  4
Eye disorders         
Dry eye  1  0/6 (0.00%)  9/33 (27.27%)  9 0/12 (0.00%)  0 8/43 (18.60%)  8
Oedema peripheral  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  7/43 (16.28%)  7
Gastrointestinal disorders         
Constipation  1  3/6 (50.00%)  3 13/33 (39.39%)  13 0/12 (0.00%)  0 24/43 (55.81%)  24
Dry mouth  1  5/6 (83.33%)  5 15/33 (45.45%)  15 0/12 (0.00%)  0 18/43 (41.86%)  18
Stomatis  1  5/6 (83.33%)  5 10/33 (30.30%)  10 6/12 (50.00%)  6 18/43 (41.86%)  18
Diarrhoea  1  3/6 (50.00%)  3 12/33 (36.36%)  12 4/12 (33.33%)  4 14/43 (32.56%)  14
Vomiting  1  3/6 (50.00%)  3 10/33 (30.30%)  10 5/12 (41.67%)  5 11/43 (25.58%)  11
Nausea  1  3/6 (50.00%)  3 9/33 (27.27%)  9 0/12 (0.00%)  0 11/43 (25.58%)  11
Abdominal pain  1  2/6 (33.33%)  2 0/33 (0.00%)  0/12 (0.00%)  5/43 (11.63%)  5
Dyspepsia  1  1/6 (16.67%)  1 0/33 (0.00%)  0/12 (0.00%)  5/43 (11.63%)  5
General disorders         
Fatigue  1  2/6 (33.33%)  2 13/33 (39.39%)  13 4/12 (33.33%)  4 10/43 (23.26%)  10
Asthenia  1  2/6 (33.33%)  2 4/33 (12.12%)  4 0/12 (0.00%)  0 9/43 (20.93%)  9
Pyrexia  1  1/6 (16.67%)  1 0/33 (0.00%)  0/12 (0.00%)  5/43 (11.63%)  5
Investigations         
ALT increased  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  4/43 (9.30%)  4
Metabolism and nutrition disorders         
Hyperphosphataemia  1  2/6 (33.33%)  2 6/33 (18.18%)  6 0/12 (0.00%)  20/43 (46.51%)  20
Decreased appetite  1  0/6 (0.00%)  0 11/33 (33.33%)  11 6/12 (50.00%)  6 12/43 (27.91%)  12
Ageusia  1  4/6 (66.67%)  4 0/33 (0.00%)  0/12 (0.00%)  8/43 (18.60%)  8
Musculoskeletal and connective tissue disorders         
Back pain  1  0/6 (0.00%)  0 0/33 (0.00%)  0 0/12 (0.00%)  0 13/43 (30.23%)  13
Nervous system disorders         
Headache  1  2/6 (33.33%)  2 0/33 (0.00%)  0/12 (0.00%)  6/43 (13.95%)  6
Dysgeusia  1  1/6 (16.67%)  1 0/33 (0.00%)  0/12 (0.00%)  5/43 (11.63%)  5
Dyspepsia  1  1/6 (16.67%)  1 0/33 (0.00%)  0/12 (0.00%)  5/43 (11.63%)  5
Muscle spasms  1  1/6 (16.67%)  1 0/33 (0.00%)  0/12 (0.00%)  5/43 (11.63%)  5
Lethargy  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  7/43 (16.28%)  7
Insomnia  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  5/43 (11.63%)  5
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  0/6 (0.00%)  0 4/33 (12.12%)  4 0/12 (0.00%)  0 7/43 (16.28%)  7
Epistaxis  1  0/6 (0.00%)  0 6/33 (18.18%)  6 0/12 (0.00%)  0 8/43 (18.60%)  8
Nasal congestion  1  1/6 (16.67%)  1 0/33 (0.00%)  0/12 (0.00%)  5/43 (11.63%)  5
Dysphonia  1  2/6 (33.33%)  2 0/33 (0.00%)  0/12 (0.00%)  4/43 (9.30%)  4
Breath sounds abnormal  1  0/6 (0.00%)  5/33 (15.15%)  5 0/12 (0.00%)  0/43 (0.00%) 
Cough  1  0/6 (0.00%)  0/33 (0.00%)  0/12 (0.00%)  10/43 (23.26%)  10
Skin and subcutaneous tissue disorders         
Alopecia  1  2/6 (33.33%)  2 8/33 (24.24%)  8 0/12 (0.00%)  0 21/43 (48.84%)  21
Dry skin  1  1/6 (16.67%)  1 8/33 (24.24%)  8 0/12 (0.00%)  0 18/43 (41.86%)  18
Nail disorder  1  0/6 (0.00%)  0 7/33 (21.21%)  7 0/12 (0.00%)  0 15/43 (34.88%)  15
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 14.1.

Due to early termination no AUC(inf), Cmax, Css,max and AUC,ss for Part C (PK). Data from 33 patients after 22 days of multiple dosing in Part A & limited data for part B only.

1 subject not dosed, so pre-stated subject number 95, total with data 94.

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
Layout table for Results Point of Contact information
Name/Title: Donal Landers
Organization: AstraZeneca
Phone: +44 1625 231890
EMail: Donal.Landers@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00979134    
Other Study ID Numbers: D2610C00001
First Submitted: September 16, 2009
First Posted: September 17, 2009
Results First Submitted: April 1, 2016
Results First Posted: March 15, 2019
Last Update Posted: March 15, 2019