Assess the Efficacy of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Gastric Cancer
Sponsor
AstraZeneca (Industry)
Overall Status
Terminated
CT.gov ID
NCT01579578
Collaborator
(none)
39
15
2
11
2.6
0.2
Study Details
Study Description
Brief Summary
The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
A Phase IIa Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination with Paclitaxel versus Paclitaxel alone in Patients with Metastatic, Gastric or Gastro-oesophageal Junction, Cancer who progress following First Line Therapy and are Ineligible for Treatment with trastuzumab by HER2 Status (SAGE)
Study Design
Study Type:
Interventional
Actual Enrollment
:
39 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase IIa Multi-centre Randomised Double-Blind Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Metastatic, Gastric or Gastro-oesophageal Junction, Cancer Who Progress Following First Line Therapy and Are Ineligible for Treatment With Trastuzumab by HER2 Status (SAGE)
Study Start Date
:
Apr 1, 2012
Actual Primary Completion Date
:
Mar 1, 2013
Actual Study Completion Date
:
Mar 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: AZD8931
40 mg, oral dose twice daily
Drug: Paclitaxel
IV once weekly for 3 weeks followed by a week off.
|
| Placebo Comparator: 2
|
Drug: Placebo
Placebo, oral dose twice daily
Drug: Paclitaxel
IV once weekly for 3 weeks followed by a week off.
|
Outcome Measures
Primary Outcome Measures
- Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone [Baseline and 8 weeks, accessed up to data cut off on 4 December 2012]
Secondary Outcome Measures
- Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone [Baseline and every 8 weeks, accessed up to data cut off on 4 December 2012]
Time from the date of randomization until the date of objective disease progression (as per RECIST1.1) or the date of death (by any cause in absence of progression).
- The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone [Baseline and 8 weeks, accessed up to data cut off on 4 December 2012]
The number of subjects with at least one visit response of CR or PR. (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; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline)
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male or female aged 18 years or older (20 years or older in Japan)
-
Patients must have radiologically confirmed progression following 1st line fluoropyrimidine and platinum based treatment for metastatic gastric cancer (the date of progression and start of first line treatment to be captured on the database)
-
Suitable for paclitaxel therapy.
-
At least one lesion, not previously irradiated and not chosen for a mandatory fresh tumour biopsy during the study screening period, that can be accurately measured at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) and is suitable for accurate repeat assessment.
-
Ineligible for trastuzumab treatment by local assessment. This should include IHC analysis to determine HER2 status with further testing by FISH/CISH when considered part of local practice. Eligible patients are defined as; HER2 IHC 0, HER2 IHC +1 and +2
Exclusion Criteria:
-
Have received more than 1 prior chemotherapy regimen for metastatic gastric cancer. (chemotherapy as adjuvant treatment is permitted).
-
Any prior taxane therapy (at any time from diagnosis of gastric cancer)
-
Any prior therapy with an inhibitor of ErbB1 (EGFR) or ErbB2 (HER2) (eg, lapatinib)
-
Resting ECG with measurable QTc(F) interval of greater than 480 msec at 2 or more time points within a 24 hour period (see section 6.4.9.1 )
-
Unresolved toxicity grater than CTCAE grade 2 (except alopecia) from previous anti-cancer therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | Hamburg | Germany | ||
| 2 | Research Site | Köln | Germany | ||
| 3 | Research Site | Chuo-ku | Japan | ||
| 4 | Research Site | Fukuoka-shi | Japan | ||
| 5 | Research Site | Kawasaki-shi | Japan | ||
| 6 | Research Site | Matsuyama-shi | Japan | ||
| 7 | Research Site | Sapporo-shi | Japan | ||
| 8 | Research Site | Jeonju-si | Korea, Republic of | ||
| 9 | Research Site | Seongnam-si | Korea, Republic of | ||
| 10 | Research Site | Seoul | Korea, Republic of | ||
| 11 | Research Site | Barcelona | Spain | ||
| 12 | Research Site | Madrid | Spain | ||
| 13 | Research Site | Valencia | Spain | ||
| 14 | Research Site | Taichung | Taiwan | ||
| 15 | Research Site | Taipei | Taiwan |
Sponsors and Collaborators
- AstraZeneca
Investigators
- Study Director: Serban Ghiorghiu, M. D., Scarborough General Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01579578
Other Study ID Numbers:
- D0102C00006
First Posted:
Apr 18, 2012
Last Update Posted:
Sep 12, 2014
Last Verified:
Sep 1, 2014
Keywords provided by AstraZeneca
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Due to the early stopping of this study as a result of the AZD8931 program being stopped, the full planned enrolment was not carried out. This study was stopped after 39 were enrolled, 25 of whom were treated, which is less than the number planned in the protocol. |
|---|---|
| Pre-assignment Detail | Due to the early stopping of this study as a result of the AZD8931 program being stopped, the full planned enrolment was not carried out. This study was stopped after 39 were enrolled, 25 of whom were treated, which is less than the number planned in the protocol. |
| Arm/Group Title | AZD8931 40mg + Paclitaxel | Placebo + Paclitaxel |
|---|---|---|
| Arm/Group Description | AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle | AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle |
| Period Title: Overall Study | ||
| STARTED | 13 | 12 |
| Ongoing | 3 | 0 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 13 | 12 |
Baseline Characteristics
| Arm/Group Title | AZD8931 40mg + Paclitaxel | Placebo + Paclitaxel | Total |
|---|---|---|---|
| Arm/Group Description | AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle | AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle | Total of all reporting groups |
| Overall Participants | 13 | 12 | 25 |
| Age (Years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [Years] |
57.9
(8.71)
|
62.7
(13.60)
|
60.2
(11.34)
|
| Age, Customized (Number) [Number] | |||
| 18 - < 50 years |
3
23.1%
|
2
16.7%
|
5
20%
|
| 50 - < 65 years |
7
53.8%
|
4
33.3%
|
11
44%
|
| 65 - < 75 years |
3
23.1%
|
5
41.7%
|
8
32%
|
| >= 75 years |
0
0%
|
1
8.3%
|
1
4%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
4
30.8%
|
3
25%
|
7
28%
|
| Male |
9
69.2%
|
9
75%
|
18
72%
|
| Race/Ethnicity, Customized (Number) [Number] | |||
| Asian |
13
100%
|
12
100%
|
25
100%
|
| Race/Ethnicity, Customized (Number) [Number] | |||
| Asian (Other Than Chinese or Japanese) |
8
61.5%
|
7
58.3%
|
15
60%
|
| Chinese |
1
7.7%
|
2
16.7%
|
3
12%
|
| Japanese |
4
30.8%
|
3
25%
|
7
28%
|
| HER2 Status: HER2/IHC (Local Assessment) (Number) [Number] | |||
| HER2 0 No staining/membrane staining <10% of cells |
8
61.5%
|
6
50%
|
14
56%
|
| HER2 1+ Faint membrane staining ≥10% of cells |
3
23.1%
|
5
41.7%
|
8
32%
|
| HER2 2+ Weak/moderate membrane staining ≥10% cells |
2
15.4%
|
1
8.3%
|
3
12%
|
Outcome Measures
| Title | Change in Tumour Size at 8 Weeks Were Analyzed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone |
|---|---|
| Description | |
| Time Frame | Baseline and 8 weeks, accessed up to data cut off on 4 December 2012 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | AZD8931 + Paclitaxel | Placebo + Paclitaxel |
|---|---|---|
| Arm/Group Description | AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle | AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle |
| Measure Participants | 11 | 11 |
| Measure change from baseline | 8 | 9 |
| Least Squares Mean (Standard Error) [percentage change] |
-7.7
(8.60)
|
-2.7
(8.64)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | AZD8931 + Paclitaxel, Placebo + Paclitaxel |
|---|---|---|
| Comments | 60 patients had been considered to detect a -20% difference in the estimated average percentage change in tumour size at 8 weeks for AZD8931 plus paclitaxel compared to paclitaxel alone at a one-sided significance level of 10% with 90% power. This is based on a standard deviation of 30% for tumour data (on an absolute scale) | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.688 |
| Comments | two sided p value | |
| Method | ANCOVA | |
| Comments | ANCOVA model including covariates for baseline tumour size, for the time from the baseline scan to randomisation and with a term for HER2 status. | |
| Method of Estimation | Estimation Parameter | Mean Difference (Final Values) |
| Estimated Value | -5.00 | |
| Confidence Interval |
(2-Sided) 95% -30.81 to 20.81 |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 12.23 |
|
| Estimation Comments | the difference in LS means is estimated | |
| Title | Progression-free Survival (PFS) Were Analysed for Comparing Relative Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone |
|---|---|
| Description | Time from the date of randomization until the date of objective disease progression (as per RECIST1.1) or the date of death (by any cause in absence of progression). |
| Time Frame | Baseline and every 8 weeks, accessed up to data cut off on 4 December 2012 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | AZD8931 + Paclitaxel | Placebo + Paclitaxel |
|---|---|---|
| Arm/Group Description | AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle | AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle |
| Measure Participants | 13 | 12 |
| Measure events | 8 | 8 |
| Median (Inter-Quartile Range) [months] |
3.7
|
3.5
|
| Title | The Objective Response Rate (ORR) Was Analysed for Investigating the Efficacy of AZD8931 Plus Paclitaxel With Paclitaxel Alone |
|---|---|
| Description | The number of subjects with at least one visit response of CR or PR. (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; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD), A ≥ 20% increase in the sum of diameters of target lesions and an absolute increase of ≥ 5mm; Stable disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Not Evaluable (NE), All target lesion measurements are missing or >1/3 target lesion measurements are missing and sum of diameters of non-missing target lesions does not qualify for PD; Not applicable (NA), No target lesions are recorded at baseline) |
| Time Frame | Baseline and 8 weeks, accessed up to data cut off on 4 December 2012 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full analysis set |
| Arm/Group Title | AZD8931 + Paclitaxel | Placebo + Paclitaxel |
|---|---|---|
| Arm/Group Description | AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle | AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle |
| Measure Participants | 13 | 12 |
| Total |
3
23.1%
|
0
0%
|
| Complete Response |
0
0%
|
0
0%
|
| Partial Response |
3
23.1%
|
0
0%
|
Adverse Events
| Time Frame | AEs will be collected from time of signed informed consent throughout the treatment period and for 30 days after the last dose of AZD8931 /placebo | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | AZD8931 40mg + Paclitaxel | Placebo + Paclitaxel | ||
| Arm/Group Description | AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle | AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle | ||
All Cause Mortality |
||||
| AZD8931 40mg + Paclitaxel | Placebo + Paclitaxel | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| AZD8931 40mg + Paclitaxel | Placebo + Paclitaxel | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/13 (46.2%) | 3/12 (25%) | ||
| Blood and lymphatic system disorders | ||||
| Febrile neutropenia | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Neutropenia | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Diarrhoea | 2/13 (15.4%) | 3 | 0/12 (0%) | 0 |
| General disorders | ||||
| Asthenia | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Pyrexia | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Hepatobiliary disorders | ||||
| Bile duct obstruction | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Infections and infestations | ||||
| Peritonitis | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Biliary tract infection | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 2/13 (15.4%) | 2 | 0/12 (0%) | 0 |
| Hyperkalaemia | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Muscular weakness | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Tumour haemorrhage | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Vascular disorders | ||||
| Hypotension | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| AZD8931 40mg + Paclitaxel | Placebo + Paclitaxel | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 13/13 (100%) | 12/12 (100%) | ||
| Blood and lymphatic system disorders | ||||
| Anaemia | 3/13 (23.1%) | 5 | 4/12 (33.3%) | 9 |
| Febrile neutropenia | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Neutropenia | 6/13 (46.2%) | 8 | 3/12 (25%) | 9 |
| Leukocytosis | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Leukopenia | 0/13 (0%) | 0 | 2/12 (16.7%) | 7 |
| Cardiac disorders | ||||
| Ventricular extrasystoles | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Vertigo | 2/13 (15.4%) | 2 | 0/12 (0%) | 0 |
| Eye disorders | ||||
| Accommodation disorder | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Blepharitis | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Scleral discolouration | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Vision blurred | 3/13 (23.1%) | 3 | 0/12 (0%) | 0 |
| Meibomian gland dysfunction | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 2/13 (15.4%) | 2 | 2/12 (16.7%) | 2 |
| Abdominal pain upper | 1/13 (7.7%) | 1 | 1/12 (8.3%) | 1 |
| Constipation | 4/13 (30.8%) | 4 | 1/12 (8.3%) | 1 |
| Diarrhoea | 6/13 (46.2%) | 13 | 5/12 (41.7%) | 5 |
| Nausea | 3/13 (23.1%) | 4 | 2/12 (16.7%) | 2 |
| Stomatitis | 6/13 (46.2%) | 6 | 1/12 (8.3%) | 1 |
| Vomiting | 3/13 (23.1%) | 4 | 3/12 (25%) | 3 |
| Anal inflammation | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Ascites | 0/13 (0%) | 0 | 2/12 (16.7%) | 3 |
| Dyspepsia | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Dysphagia | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| General disorders | ||||
| Asthenia | 4/13 (30.8%) | 4 | 1/12 (8.3%) | 1 |
| Fatigue | 5/13 (38.5%) | 5 | 4/12 (33.3%) | 5 |
| Mucosal inflammation | 2/13 (15.4%) | 2 | 0/12 (0%) | 0 |
| Oedema | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Oedema peripheral | 2/13 (15.4%) | 2 | 3/12 (25%) | 4 |
| Pyrexia | 2/13 (15.4%) | 2 | 3/12 (25%) | 3 |
| Gait disturbance | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Irritability | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Hepatobiliary disorders | ||||
| Jaundice | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Hepatic failure | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Bile duct obstruction | 0/13 (0%) | 0 | 1/12 (8.3%) | 2 |
| Infections and infestations | ||||
| Bacteriuria | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Cystitis | 1/13 (7.7%) | 2 | 0/12 (0%) | 0 |
| Lung infection | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Nasopharyngitis | 1/13 (7.7%) | 1 | 1/12 (8.3%) | 2 |
| Oral infection | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Paronychia | 2/13 (15.4%) | 2 | 1/12 (8.3%) | 1 |
| Urinary tract infection | 1/13 (7.7%) | 2 | 1/12 (8.3%) | 1 |
| Biliary tract infection | 0/13 (0%) | 0 | 1/12 (8.3%) | 2 |
| Gastroenteritis norovirus | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Vascular access complication | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Fall | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Spinal fracture | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Postoperative wound complication | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Investigations | ||||
| Alanine aminotransferase increased | 1/13 (7.7%) | 1 | 1/12 (8.3%) | 1 |
| Aspartate aminotransferase increased | 2/13 (15.4%) | 2 | 1/12 (8.3%) | 1 |
| Blood bilirubin increased | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Blood creatinine increased | 1/13 (7.7%) | 1 | 1/12 (8.3%) | 1 |
| Gamma-glutamyltransferase increased | 1/13 (7.7%) | 1 | 2/12 (16.7%) | 4 |
| Haemoglobin decreased | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Neutrophil count decreased | 2/13 (15.4%) | 3 | 2/12 (16.7%) | 4 |
| Weight decreased | 2/13 (15.4%) | 2 | 0/12 (0%) | 0 |
| White blood cell count decreased | 1/13 (7.7%) | 3 | 2/12 (16.7%) | 3 |
| Blood alkaline phosphatase increased | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Platelet count decreased | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Metabolism and nutrition disorders | ||||
| Decreased appetite | 5/13 (38.5%) | 6 | 3/12 (25%) | 4 |
| Hyperglycaemia | 1/13 (7.7%) | 1 | 1/12 (8.3%) | 1 |
| Hyperkalaemia | 1/13 (7.7%) | 3 | 0/12 (0%) | 0 |
| Hyperphosphataemia | 1/13 (7.7%) | 2 | 0/12 (0%) | 0 |
| Hypoalbuminaemia | 5/13 (38.5%) | 8 | 3/12 (25%) | 4 |
| Hypokalaemia | 2/13 (15.4%) | 3 | 2/12 (16.7%) | 2 |
| Hyponatraemia | 1/13 (7.7%) | 1 | 1/12 (8.3%) | 1 |
| Hypophosphataemia | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Hypocalcaemia | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Myalgia | 1/13 (7.7%) | 2 | 1/12 (8.3%) | 2 |
| Arthralgia | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Back pain | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Muscular weakness | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Malignant peritoneal neoplasm | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Nervous system disorders | ||||
| Dizziness | 2/13 (15.4%) | 2 | 0/12 (0%) | 0 |
| Dysgeusia | 2/13 (15.4%) | 2 | 0/12 (0%) | 0 |
| Hypoaesthesia | 1/13 (7.7%) | 1 | 2/12 (16.7%) | 2 |
| Neuropathy peripheral | 2/13 (15.4%) | 2 | 1/12 (8.3%) | 1 |
| Peripheral sensory neuropathy | 4/13 (30.8%) | 4 | 2/12 (16.7%) | 2 |
| Syncope | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Psychiatric disorders | ||||
| Insomnia | 1/13 (7.7%) | 1 | 3/12 (25%) | 3 |
| Confusional state | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Renal and urinary disorders | ||||
| Haematuria | 1/13 (7.7%) | 1 | 1/12 (8.3%) | 1 |
| Proteinuria | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Renal failure acute | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Vulval oedema | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Hiccups | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Productive cough | 2/13 (15.4%) | 2 | 1/12 (8.3%) | 1 |
| Dyspnoea | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Pulmonary embolism | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Nasal inflammation | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Alopecia | 6/13 (46.2%) | 6 | 3/12 (25%) | 3 |
| Dermatitis acneiform | 5/13 (38.5%) | 6 | 2/12 (16.7%) | 2 |
| Dry skin | 3/13 (23.1%) | 3 | 0/12 (0%) | 0 |
| Palmar-plantar erythrodysaesthesia syndrome | 2/13 (15.4%) | 2 | 0/12 (0%) | 0 |
| Pruritus | 2/13 (15.4%) | 2 | 2/12 (16.7%) | 2 |
| Rash | 5/13 (38.5%) | 6 | 0/12 (0%) | 0 |
| Rash maculo-papular | 2/13 (15.4%) | 2 | 1/12 (8.3%) | 1 |
| Skin fissures | 1/13 (7.7%) | 1 | 0/12 (0%) | 0 |
| Erythema | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Purpura | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
| Vascular disorders | ||||
| Flushing | 1/13 (7.7%) | 2 | 0/12 (0%) | 0 |
| Hypotension | 1/13 (7.7%) | 1 | 2/12 (16.7%) | 2 |
| Hypertension | 0/13 (0%) | 0 | 1/12 (8.3%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Dr Serban Ghiorghiu |
|---|---|
| Organization | AstraZeneca |
| Phone | |
| ClinicalTrialTransparency@astrazeneca.com |
Responsible Party:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01579578
Other Study ID Numbers:
- D0102C00006
First Posted:
Apr 18, 2012
Last Update Posted:
Sep 12, 2014
Last Verified:
Sep 1, 2014