Global Phase1 Study to Assess the Safety and Tolerability of AZD1208 in Advanced Solid Tumors and Malignant Lymphoma
Sponsor
AstraZeneca (Industry)
Overall Status
Completed
CT.gov ID
NCT01588548
Collaborator
(none)
43
3
1
24
14.3
0.6
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the safety and tolerability of AZD 1208 up to a maximum tolerated dose (MTD) and define the dose(s) for further clinical evaluation when given daily to patients with advanced solid malignancies including malignant lymphoma
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients with Advanced Solid Malignancies including Malignant Lymphoma
Study Design
Study Type:
Interventional
Actual Enrollment
:
43 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD1208 in Patients With Advanced Solid Malignancies Including Malignant Lymphoma
Study Start Date
:
Jul 1, 2012
Actual Primary Completion Date
:
Jul 1, 2014
Actual Study Completion Date
:
Jul 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: AZD1208
|
Drug: AZD1208
Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose
|
Outcome Measures
Primary Outcome Measures
- Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) [Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 130 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients who have signed this Written Informed Consent Form after a full explanation about the participation in this study
-
Patients aged 18 years or older Patients diagnosed with a solid malignant tumour or malignant lymphoma that is refractory to standard therapies or for which no standard therapies exist
-
Patients with good physical conditions (you can walk and can look after yourself) within the last 2 weeks.
-
Patients who have at least one lesion that can be accurately assessed
Exclusion Criteria:
-
Patients who have recently received or are receiving prohibited medications or treatments
-
Patients who have any unresolved side effects of previous treatments
-
Patients who have spinal cord compression or brain metastases
-
Patients who have severe systemic diseases (e.g., uncontrolled hypertension, hepatitis B, hepatitis C and human immunodeficiency virus [HIV] infection)
-
Patients with significant abnormal ECG findings
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Chuo-ku | Japan | ||
| 2 | Research Site | Manchester | United Kingdom | ||
| 3 | Research Site | Surrey | United Kingdom |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Frank Neumann, MSD, AZ
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01588548
Other Study ID Numbers:
- D4510C00005
First Posted:
May 1, 2012
Last Update Posted:
Nov 4, 2015
Last Verified:
Oct 1, 2015
Keywords provided by AstraZeneca
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 43 patients were enrolled to the study, of which 35 recieved doses of AZD1208 between 120mg and 800mg. The other 8 patients did not receive AZD1208. |
| Arm/Group Title | AZD1208 120mg | AZD1208 240mg | AZD1208 360mg | AZD1208 540mg | AZD1208 700mg | AZD1208 800mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. |
| Period Title: Overall Study | ||||||
| STARTED | 3 | 7 | 6 | 7 | 6 | 6 |
| Cycle 1 Day 21 | 3 | 5 | 2 | 5 | 3 | 3 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 3 | 7 | 6 | 7 | 6 | 6 |
Baseline Characteristics
| Arm/Group Title | AZD1208 120mg | AZD1208 240mg | AZD1208 360mg | AZD1208 540mg | AZD1208 700mg | AZD1208 800mg | Total |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Total of all reporting groups |
| Overall Participants | 3 | 7 | 6 | 7 | 6 | 6 | 35 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||
| Mean (Standard Deviation) [Years] |
54.0
(9.00)
|
59.4
(9.81)
|
63.5
(14.38)
|
62.3
(17.01)
|
66.5
(12.85)
|
60.8
(12.45)
|
61.7
(12.70)
|
| Sex: Female, Male (Count of Participants) | |||||||
| Female |
2
66.7%
|
4
57.1%
|
2
33.3%
|
3
42.9%
|
4
66.7%
|
3
50%
|
18
51.4%
|
| Male |
1
33.3%
|
3
42.9%
|
4
66.7%
|
4
57.1%
|
2
33.3%
|
3
50%
|
17
48.6%
|
Outcome Measures
| Title | Best Objective Response Based on RECIST Criteria (Evaluable for Response Analysis Set for RECIST Criteria) |
|---|---|
| Description | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions (TL)s since baseline and any pathological lymph nodes selected as TLs must have a reduction in short axis to <10 mm; Partial Response (PR), at least a 30% decrease in the sum of diameters of TLs; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Progressive Disease (PD), at least a 20% increase in the sum of diameters of TLs and an absolute increase of at least 5 mm; Not Evaluable (NE), this is only relevant if any of the TLs were not assessed or not evaluable or had a lesion intervention at this visit, also note that if the sum of diameters meets the progressive disease criteria, progressive disease overrides not evaluable as a TL response. Best objective response is the best response a patient experiences over the randomised treatment period. |
| Time Frame | Measurements occur at screening (<=28 days before start of study treatment), every 6 weeks (+/-1 week) up to 12 weeks and then every 12 weeks (+/-1 week) until discontinuation of study treatment or withdrawal of consent, starting from Day 1 of Cycle 1 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who were evaluable for Response analysis set for RECIST criteria |
| Arm/Group Title | AZD1208 120mg | AZD1208 240mg | AZD1208 360mg | AZD1208 540mg | AZD1208 700mg | AZD1208 800mg |
|---|---|---|---|---|---|---|
| Arm/Group Description | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. |
| Measure Participants | 3 | 7 | 5 | 7 | 6 | 5 |
| CR |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| PR |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| SD >=6 weeks (unconfirmed CR or PR) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| SD >=6 weeks (SD) |
2
66.7%
|
5
71.4%
|
1
16.7%
|
3
42.9%
|
1
16.7%
|
1
16.7%
|
| PD (RECIST progression) |
1
33.3%
|
2
28.6%
|
3
50%
|
3
42.9%
|
2
33.3%
|
3
50%
|
| PD (Death) |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
| Not evaluable (SD < 6 weeks) |
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
2
33.3%
|
0
0%
|
| Not evaluable(Incomplete postbaseline assessments) |
0
0%
|
0
0%
|
0
0%
|
1
14.3%
|
0
0%
|
1
16.7%
|
Adverse Events
| Time Frame | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||
| Arm/Group Title | AZD1208 120mg | AZD1208 240mg | AZD1208 360mg | AZD1208 540mg | AZD1208 700mg | AZD1208 800mg | ||||||
| Arm/Group Description | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | Once daily continuous dosing schedule. | ||||||
All Cause Mortality |
||||||||||||
| AZD1208 120mg | AZD1208 240mg | AZD1208 360mg | AZD1208 540mg | AZD1208 700mg | AZD1208 800mg | |||||||
| 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 | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||
Serious Adverse Events |
||||||||||||
| AZD1208 120mg | AZD1208 240mg | AZD1208 360mg | AZD1208 540mg | AZD1208 700mg | AZD1208 800mg | |||||||
| 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 | 0/3 (0%) | 2/7 (28.6%) | 2/6 (33.3%) | 2/7 (28.6%) | 2/6 (33.3%) | 0/6 (0%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Vomiting | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Abdominal Pain | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Intestinal Obstruction | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Nausea | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| General disorders | ||||||||||||
| Fatigue | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| General Physical Health Deterioration | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Bacterial Infection | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Balance Disorder | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Renal and urinary disorders | ||||||||||||
| Pollakiuria | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Dyspnoea | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Chronic Obstructive Pulmonary Disease | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Pleural Effusion | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
Other (Not Including Serious) Adverse Events |
||||||||||||
| AZD1208 120mg | AZD1208 240mg | AZD1208 360mg | AZD1208 540mg | AZD1208 700mg | AZD1208 800mg | |||||||
| 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 | 3/3 (100%) | 7/7 (100%) | 6/6 (100%) | 7/7 (100%) | 6/6 (100%) | 6/6 (100%) | ||||||
| Blood and lymphatic system disorders | ||||||||||||
| Anaemia | 3/3 (100%) | 4/7 (57.1%) | 2/6 (33.3%) | 4/7 (57.1%) | 3/6 (50%) | 2/6 (33.3%) | ||||||
| Thrombocytopenia | 0/3 (0%) | 0/7 (0%) | 2/6 (33.3%) | 1/7 (14.3%) | 1/6 (16.7%) | 1/6 (16.7%) | ||||||
| Leukopenia | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Lymphadenitis | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Cardiac disorders | ||||||||||||
| Atrial Fibrillation | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Eye disorders | ||||||||||||
| Dry Eye | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Vision Blurred | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Gastrointestinal disorders | ||||||||||||
| Diarrhoea | 2/3 (66.7%) | 5/7 (71.4%) | 5/6 (83.3%) | 6/7 (85.7%) | 5/6 (83.3%) | 6/6 (100%) | ||||||
| Nausea | 1/3 (33.3%) | 6/7 (85.7%) | 3/6 (50%) | 7/7 (100%) | 5/6 (83.3%) | 4/6 (66.7%) | ||||||
| Vomiting | 0/3 (0%) | 6/7 (85.7%) | 1/6 (16.7%) | 5/7 (71.4%) | 4/6 (66.7%) | 3/6 (50%) | ||||||
| Abdominal Pain | 0/3 (0%) | 3/7 (42.9%) | 2/6 (33.3%) | 2/7 (28.6%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Constipation | 0/3 (0%) | 0/7 (0%) | 3/6 (50%) | 0/7 (0%) | 2/6 (33.3%) | 0/6 (0%) | ||||||
| Gastrooesophageal Reflux Disease | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 3/7 (42.9%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Dyspepsia | 0/3 (0%) | 1/7 (14.3%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Abdominal Discomfort | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Abdominal Distension | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Abdominal Tenderness | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Cheilitis | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Dry Mouth | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Dysphagia | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Haemorrhoidal Haemorrhage | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Haemorrhoids | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Intestinal Obstruction | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Stomatitis | 1/3 (33.3%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| General disorders | ||||||||||||
| Fatigue | 0/3 (0%) | 2/7 (28.6%) | 3/6 (50%) | 3/7 (42.9%) | 4/6 (66.7%) | 5/6 (83.3%) | ||||||
| Pyrexia | 0/3 (0%) | 1/7 (14.3%) | 3/6 (50%) | 0/7 (0%) | 2/6 (33.3%) | 0/6 (0%) | ||||||
| Chest Pain | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Chills | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Device Occlusion | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| General Physical Health Deterioration | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Hernia | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Malaise | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Mucosal Inflammation | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Oedema Peripheral | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Suprapubic Pain | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Hepatobiliary disorders | ||||||||||||
| Hepatic Pain | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Infections and infestations | ||||||||||||
| Urinary Tract Infection | 0/3 (0%) | 1/7 (14.3%) | 1/6 (16.7%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Oral Candidiasis | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 2/6 (33.3%) | 0/6 (0%) | ||||||
| Upper Respiratory Tract Infection | 1/3 (33.3%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Bacterial Infection | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Lower Respiratory Tract Infection | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Lung Infection | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Paronychia | 1/3 (33.3%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Vaginal Infection | 1/3 (33.3%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Injury, poisoning and procedural complications | ||||||||||||
| Arthropod Bite | 1/3 (33.3%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Fall | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Investigations | ||||||||||||
| Platelet Count Decreased | 2/3 (66.7%) | 2/7 (28.6%) | 1/6 (16.7%) | 2/7 (28.6%) | 1/6 (16.7%) | 1/6 (16.7%) | ||||||
| White Blood Cell Count Decreased | 2/3 (66.7%) | 3/7 (42.9%) | 1/6 (16.7%) | 2/7 (28.6%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Gamma-Glutamyltransferase Increased | 0/3 (0%) | 2/7 (28.6%) | 1/6 (16.7%) | 2/7 (28.6%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Aspartate Aminotransferase Increased | 0/3 (0%) | 2/7 (28.6%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Blood Creatinine Increased | 0/3 (0%) | 1/7 (14.3%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Lymphocyte Count Decreased | 0/3 (0%) | 1/7 (14.3%) | 2/6 (33.3%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Alanine Aminotransferase Increased | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Blood Alkaline Phosphatase Increased | 0/3 (0%) | 2/7 (28.6%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Neutrophil Count Decreased | 0/3 (0%) | 2/7 (28.6%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Oxygen Saturation Decreased | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 2/6 (33.3%) | 0/6 (0%) | ||||||
| Blood Creatine Phosphokinase Increased | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Blood Urea Increased | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Breath Sounds Abnormal | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Electrocardiogram Qt Prolonged | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Gastrointestinal Stoma Output Decreased | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Weight Decreased | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Metabolism and nutrition disorders | ||||||||||||
| Decreased Appetite | 1/3 (33.3%) | 3/7 (42.9%) | 2/6 (33.3%) | 4/7 (57.1%) | 2/6 (33.3%) | 3/6 (50%) | ||||||
| Hypoalbuminaemia | 1/3 (33.3%) | 2/7 (28.6%) | 2/6 (33.3%) | 1/7 (14.3%) | 3/6 (50%) | 0/6 (0%) | ||||||
| Hyperglycaemia | 1/3 (33.3%) | 0/7 (0%) | 1/6 (16.7%) | 4/7 (57.1%) | 0/6 (0%) | 2/6 (33.3%) | ||||||
| Hyponatraemia | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 3/7 (42.9%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Hypokalaemia | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 2/7 (28.6%) | 1/6 (16.7%) | 1/6 (16.7%) | ||||||
| Hypophosphataemia | 0/3 (0%) | 1/7 (14.3%) | 1/6 (16.7%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Hypocalcaemia | 0/3 (0%) | 2/7 (28.6%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Dehydration | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Hypomagnesaemia | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Polydipsia | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||
| Musculoskeletal Chest Pain | 0/3 (0%) | 0/7 (0%) | 2/6 (33.3%) | 1/7 (14.3%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Arthralgia | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Back Pain | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Flank Pain | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Myalgia | 1/3 (33.3%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Pain In Extremity | 0/3 (0%) | 1/7 (14.3%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Musculoskeletal Pain | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Neck Pain | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||
| Cancer Pain | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Nervous system disorders | ||||||||||||
| Lethargy | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 2/7 (28.6%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Dysgeusia | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Headache | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 2/7 (28.6%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Somnolence | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Ataxia | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Balance Disorder | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Disturbance In Attention | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Dizziness | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Dysaesthesia | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Neuropathy Peripheral | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Sensory Disturbance | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Psychiatric disorders | ||||||||||||
| Insomnia | 0/3 (0%) | 1/7 (14.3%) | 1/6 (16.7%) | 1/7 (14.3%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Anxiety | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Renal and urinary disorders | ||||||||||||
| Proteinuria | 0/3 (0%) | 3/7 (42.9%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Dysuria | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Cystitis Noninfective | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Haematuria | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Hydronephrosis | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Pollakiuria | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Polyuria | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Urinary Incontinence | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Reproductive system and breast disorders | ||||||||||||
| Pelvic Pain | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Vulvovaginal Pruritus | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||
| Dyspnoea | 0/3 (0%) | 1/7 (14.3%) | 2/6 (33.3%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Cough | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 2/7 (28.6%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Pneumonitis | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 1/7 (14.3%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Dyspnoea Exertional | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 2/6 (33.3%) | 0/6 (0%) | ||||||
| Productive Cough | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Chronic Obstructive Pulmonary Disease | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Dysaesthesia Pharynx | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Epistaxis | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Haemoptysis | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Pleural Effusion | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Pleuritic Pain | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Tachypnoea | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Upper Respiratory Tract Inflammation | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Skin and subcutaneous tissue disorders | ||||||||||||
| Dry Skin | 0/3 (0%) | 3/7 (42.9%) | 1/6 (16.7%) | 2/7 (28.6%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Rash Maculo-Papular | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 1/7 (14.3%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Rash Macular | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 1/6 (16.7%) | 0/6 (0%) | ||||||
| Nail Disorder | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Psoriasis | 1/3 (33.3%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Purpura | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Rash | 0/3 (0%) | 0/7 (0%) | 1/6 (16.7%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Skin Exfoliation | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 1/6 (16.7%) | ||||||
| Skin Fissures | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Skin Mass | 0/3 (0%) | 0/7 (0%) | 0/6 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/6 (0%) | ||||||
| Urticaria | 0/3 (0%) | 1/7 (14.3%) | 0/6 (0%) | 0/7 (0%) | 0/6 (0%) | 0/6 (0%) | ||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
AstraZeneca will manage the publication of the results of the Clinical Trial in partnership with the authors. AstraZeneca recognises that Institutions/Investigators may wish to make publications regarding Clinical Trial results. The Institution/Investigator agrees to collaborate in good faith with AstraZeneca. Prior to any such publication, the Institution/Investigator shall provide AstraZeneca with preliminary data and drafts of proposed publications.
Results Point of Contact
| Name/Title | Karen Keating |
|---|---|
| Organization | AstraZeneca |
| Phone | +1 781 839 4182 |
| karen.keating@astrazeneca.com |
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01588548
Other Study ID Numbers:
- D4510C00005
First Posted:
May 1, 2012
Last Update Posted:
Nov 4, 2015
Last Verified:
Oct 1, 2015