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Trial record 1 of 4 for:    YOSEMITE
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Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma (YOSEMITE)

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: NCT02289898
Recruitment Status : Completed
First Posted : November 13, 2014
Results First Posted : August 8, 2018
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Demcizumab
Drug: Abraxane®
Drug: gemcitabine
Drug: Placebo
Enrollment 207
Recruitment Details  
Pre-assignment Details A total of 207 subjects were randomized and 204 subjects were treated in the study.
Arm/Group Title Placebo/Placebo Arm Demcizumab/Placebo Arm Demcizumab/Demcizumab Arm
Hide Arm/Group Description Abraxane and gemcitabine plus placebo (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression. Abraxane and gemcitabine plus demcizumab (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression. Abraxane and gemcitabine plus demcizumab (3 cycles), abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus demcizumab (3 cycles), and then Abraxane and gemcitabine until disease progression.
Period Title: Overall Study
Started 68 71 65
Completed 16 18 9
Not Completed 52 53 56
Reason Not Completed
Death             5             4             3
Physician Decision             2             5             2
Withdrawal by Subject             0             4             1
Adverse Event             3             5             5
Disease progression             34             28             34
Use of another anticancer therapy             0             0             1
Other             8             7             10
Arm/Group Title Placebo/Placebo Arm Demcizumab/Placebo Arm Demcizumab/Demcizumab Arm Total
Hide Arm/Group Description Abraxane and gemcitabine plus placebo (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression. Abraxane and gemcitabine plus demcizumab (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression. Abraxane and gemcitabine plus demcizumab (3 cycles), abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus demcizumab (3 cycles), and then Abraxane and gemcitabine until disease progression. Total of all reporting groups
Overall Number of Baseline Participants 68 71 65 204
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 71 participants 65 participants 204 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
37
  54.4%
34
  47.9%
30
  46.2%
101
  49.5%
>=65 years
31
  45.6%
37
  52.1%
35
  53.8%
103
  50.5%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 68 participants 71 participants 65 participants 204 participants
62
(41 to 82)
63
(38 to 85)
66
(30 to 78)
63
(30 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 71 participants 65 participants 204 participants
Female
27
  39.7%
31
  43.7%
30
  46.2%
88
  43.1%
Male
41
  60.3%
40
  56.3%
35
  53.8%
116
  56.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 71 participants 65 participants 204 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
1
   1.5%
1
   0.5%
Asian
1
   1.5%
0
   0.0%
1
   1.5%
2
   1.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
1
   1.4%
0
   0.0%
1
   0.5%
Black or African American
1
   1.5%
0
   0.0%
0
   0.0%
1
   0.5%
White
60
  88.2%
70
  98.6%
62
  95.4%
192
  94.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
6
   8.8%
0
   0.0%
1
   1.5%
7
   3.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 68 participants 71 participants 65 participants 204 participants
Canada
3
   4.4%
5
   7.0%
4
   6.2%
12
   5.9%
Belgium
2
   2.9%
2
   2.8%
2
   3.1%
6
   2.9%
United States
17
  25.0%
18
  25.4%
15
  23.1%
50
  24.5%
United Kingdom
3
   4.4%
2
   2.8%
4
   6.2%
9
   4.4%
Australia
24
  35.3%
13
  18.3%
19
  29.2%
56
  27.5%
Spain
19
  27.9%
31
  43.7%
21
  32.3%
71
  34.8%
1.Primary Outcome
Title Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms
Hide Description Investigator assessed Kaplan-Meier estimates of progression-free survival for placebo/placebo arm and pooled demcizumab arm.
Time Frame Investigator-assessed progression-free survival time through duration of the study (2 years, 23 days).
Hide Outcome Measure Data
Hide Analysis Population Description
Placebo/placebo arm and pooled demcizumab arms (ITT population).
Arm/Group Title Placebo/Placebo Arm Demcizumab/Placebo and Demcizumab/Demcizumab
Hide Arm/Group Description:
Abraxane and gemcitabine plus placebo (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression.

Pooled demcizumab arms: Demcizumab/placebo arm – Abraxane and gemcitabine plus demcizumab (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression.

Demcizumab/demcizumab arn – Abraxane and gemcitabine plus demcizumab (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus demcizumab (3 cycles), and then Abraxane and gemcitabine until disease progression.

Overall Number of Participants Analyzed 68 136
Measure Type: Count of Participants
Unit of Measure: Participants
Progressed (event)
38
  55.9%
70
  51.5%
Died (event)
5
   7.4%
12
   8.8%
Censored, follow-up ended
3
   4.4%
7
   5.1%
Censored, follow-up ongoing
22
  32.4%
47
  34.6%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo/Placebo Arm, Demcizumab/Placebo and Demcizumab/Demcizumab
Comments Efficacy (investigator-assessed Kaplan-Meier estimates of progression-free survival) of placebo/placebo arm to the pooled demcizumab arm (i.e., placebo/placebo arm to demcizumab/placebo and demcizumab/demcizumab arms) in subjects with first-line metastatic pancreatic ductal adenocarcinoma.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.7158
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value .930
Confidence Interval (2-Sided) 95%
0.630 to 1.375
Estimation Comments [Not Specified]
Time Frame Adverse event data are collected from the time of randomization through 30 days after discontinuation from the study (30 dates from the date of the treatment termination visit). Total study duration: 2 years, 23 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo/Placebo Arm Demcizumab/Placebo Arm Demcizumab/Demcizumab Arm
Hide Arm/Group Description Abraxane and gemcitabine plus placebo (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression. Abraxane and gemcitabine plus demcizumab (3 cycles), Abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus placebo (3 cycles), and then Abraxane and gemcitabine until disease progression. Abraxane and gemcitabine plus demcizumab (3 cycles), abraxane and gemcitabine (3 cycles), Abraxane and gemcitabine plus demcizumab (3 cycles), and then Abraxane and gemcitabine until disease progression.
All-Cause Mortality
Placebo/Placebo Arm Demcizumab/Placebo Arm Demcizumab/Demcizumab Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/68 (7.35%)      12/71 (16.90%)      3/65 (4.62%)    
Hide Serious Adverse Events
Placebo/Placebo Arm Demcizumab/Placebo Arm Demcizumab/Demcizumab Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   40/68 (58.82%)      49/71 (69.01%)      34/65 (52.31%)    
Blood and lymphatic system disorders       
Febrile neutropenia  1  4/68 (5.88%)  4 1/71 (1.41%)  1 0/65 (0.00%)  0
Anaemia  1  3/68 (4.41%)  3 0/71 (0.00%)  0 1/65 (1.54%)  1
Neutropenia  1  1/68 (1.47%)  1 1/71 (1.41%)  1 2/65 (3.08%)  2
Haemolytic anaemia  1  0/68 (0.00%)  0 2/71 (2.82%)  2 0/65 (0.00%)  0
Haemolytic uraemic syndrome  1  0/68 (0.00%)  0 1/71 (1.41%)  1 1/65 (1.54%)  1
Pancytopenia  1  0/68 (0.00%)  0 0/71 (0.00%)  0 2/65 (3.08%)  2
Thrombotic thrombocytopenic purpura  1  0/68 (0.00%)  0 0/71 (0.00%)  0 2/65 (3.08%)  2
Iron deficiency anaemia  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Thrombocytopenia  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Cardiac disorders       
Cardiac failure  1  0/68 (0.00%)  0 2/71 (2.82%)  2 1/65 (1.54%)  1
Angina pectoris  1  0/68 (0.00%)  0 2/71 (2.82%)  2 0/65 (0.00%)  0
Atrial fibrillation  1  0/68 (0.00%)  0 1/71 (1.41%)  1 1/65 (1.54%)  1
Acute myocardial infarction  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Cardiac arrest  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Cardiac failure congestive  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Ear and labyrinth disorders       
Vertigo  1  1/68 (1.47%)  1 0/71 (0.00%)  0 1/65 (1.54%)  1
Papilloedema  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Gastrointestinal disorders       
Vomiting  1  5/68 (7.35%)  5 4/71 (5.63%)  4 5/65 (7.69%)  5
Diarrhoea  1  1/68 (1.47%)  1 4/71 (5.63%)  4 3/65 (4.62%)  3
Abdominal pain  1  4/68 (5.88%)  4 0/71 (0.00%)  0 3/65 (4.62%)  3
Nausea  1  4/68 (5.88%)  4 1/71 (1.41%)  1 2/65 (3.08%)  2
Gastrointestinal haemorrhage  1  0/68 (0.00%)  0 2/71 (2.82%)  2 2/65 (3.08%)  2
Ascites  1  1/68 (1.47%)  1 2/71 (2.82%)  2 0/65 (0.00%)  0
Abdominal pain upper  1  1/68 (1.47%)  1 1/71 (1.41%)  1 0/65 (0.00%)  0
Colitis  1  1/68 (1.47%)  1 1/71 (1.41%)  1 0/65 (0.00%)  0
Enterocolitis  1  0/68 (0.00%)  0 1/71 (1.41%)  1 1/65 (1.54%)  1
Gastritis  1  0/68 (0.00%)  0 2/71 (2.82%)  2 0/65 (0.00%)  0
Intestinal obstruction  1  0/68 (0.00%)  0 1/71 (1.41%)  1 1/65 (1.54%)  1
Small intestinal haemorrhage  1  0/68 (0.00%)  0 1/71 (1.41%)  1 1/65 (1.54%)  1
Upper gastrointestinal haemorrhage  1  0/68 (0.00%)  0 2/71 (2.82%)  2 0/65 (0.00%)  0
Anal fissure  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Colonic fistula  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Constipation  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Diverticular perforation  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Duodenal ulcer  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Gastric haemorrhage  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Haematemesis  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Ileus  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Intestinal stenosis  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Intra-abdominal haemorrhage  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Large intestinal obstruction  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Pancreatic duct obstruction  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Pancreatic insufficiency  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
General disorders       
Pyrexia  1  6/68 (8.82%)  6 3/71 (4.23%)  3 6/65 (9.23%)  6
Chest discomfort  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Multiple organ dysfunction syndrome  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Peripheral swelling  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Systemic inflammatory response syndrome  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Hepatobiliary disorders       
Jaundice cholestatic  1  1/68 (1.47%)  1 1/71 (1.41%)  1 1/65 (1.54%)  1
Cholangitis  1  1/68 (1.47%)  1 1/71 (1.41%)  1 0/65 (0.00%)  0
Bile duct obstruction  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Bile duct stenosis  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Cholecystitis acute  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Cholestasis  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Hepatic haematoma  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Hyperbilirubinaemia  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Jaundice  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Portal vein thrombosis  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Infections and infestations       
Sepsis  1  3/68 (4.41%)  3 4/71 (5.63%)  4 4/65 (6.15%)  4
Liver abscess  1  2/68 (2.94%)  2 2/71 (2.82%)  2 0/65 (0.00%)  0
Urinary tract infection  1  2/68 (2.94%)  2 1/71 (1.41%)  1 1/65 (1.54%)  1
Cellulitis  1  1/68 (1.47%)  1 2/71 (2.82%)  2 0/65 (0.00%)  0
Pneumonia  1  2/68 (2.94%)  2 1/71 (1.41%)  1 0/65 (0.00%)  0
Urosepsis  1  2/68 (2.94%)  2 0/71 (0.00%)  0 1/65 (1.54%)  1
Abdominal abscess  1  1/68 (1.47%)  1 0/71 (0.00%)  0 1/65 (1.54%)  1
Bacteraemia  1  0/68 (0.00%)  0 2/71 (2.82%)  2 0/65 (0.00%)  0
Lower respiratory tract infection  1  1/68 (1.47%)  1 0/71 (0.00%)  0 1/65 (1.54%)  1
Neutropenic sepsis  1  0/68 (0.00%)  0 1/71 (1.41%)  1 1/65 (1.54%)  1
Bacterial infection  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Bacterial sepsis  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Bronchitis  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Colonic abscess  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Cystitis  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Device related infection  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Escherichia bacteraemia  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Hepatic infection  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Infection  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Lung infection  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Tick-borne fever  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Pyelonephritis acute  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Septic shock  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Upper respiratory tract infection  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  2/68 (2.94%)  2 0/71 (0.00%)  0 0/65 (0.00%)  0
Toxicity to various agents  1  1/68 (1.47%)  1 1/71 (1.41%)  1 0/65 (0.00%)  0
Anaesthetic complication  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Hip fracture  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Procedural pain  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Investigations       
Blood bilirubin increased  1  1/68 (1.47%)  1 0/71 (0.00%)  0 1/65 (1.54%)  1
Liver function test increased  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Neutrophil count decreased  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Transaminases increased  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
White blood cell count decreased  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Metabolism and nutrition disorders       
Dehydration  1  2/68 (2.94%)  2 3/71 (4.23%)  3 2/65 (3.08%)  2
Hyponatraemia  1  0/68 (0.00%)  0 0/71 (0.00%)  0 2/65 (3.08%)  2
Food intolerance  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Hyperglycaemia  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Hypophosphataemia  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  2/68 (2.94%)  2 1/71 (1.41%)  1 0/65 (0.00%)  0
Myalgia  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Vertebral lesion  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer pain  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Hepatic neoplasm  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Metastases to central nervous system  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Tumour rupture  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Nervous system disorders       
Syncope  1  1/68 (1.47%)  1 0/71 (0.00%)  0 1/65 (1.54%)  1
Transient ischaemic attack  1  0/68 (0.00%)  0 1/71 (1.41%)  1 1/65 (1.54%)  1
Cerebral haemorrhage  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Cerebral infarction  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Cerebrovascular accident  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Generalised tonic-clonic seizure  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Peroneal nerve palsy  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Presyncope  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Product Issues       
Device dislocation  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Psychiatric disorders       
Anxiety  1  1/68 (1.47%)  1 1/71 (1.41%)  1 0/65 (0.00%)  0
Confusional state  1  1/68 (1.47%)  1 0/71 (0.00%)  0 1/65 (1.54%)  1
Delirium  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Mental status changes  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Renal and urinary disorders       
Acute kidney injury  1  0/68 (0.00%)  0 0/71 (0.00%)  0 3/65 (4.62%)  3
Renal failure  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Renal injury  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  2/68 (2.94%)  2 2/71 (2.82%)  2 0/65 (0.00%)  0
Pleural effusion  1  2/68 (2.94%)  2 1/71 (1.41%)  1 0/65 (0.00%)  0
Pulmonary embolism  1  2/68 (2.94%)  2 0/71 (0.00%)  0 0/65 (0.00%)  0
Pulmonary hypertension  1  0/68 (0.00%)  0 2/71 (2.82%)  2 0/65 (0.00%)  0
Respiratory failure  1  1/68 (1.47%)  1 0/71 (0.00%)  0 1/65 (1.54%)  1
Acute respiratory distress syndrome  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Orthopnoea  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Pneumonitis  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Pneumothorax  1  1/68 (1.47%)  1 0/71 (0.00%)  0 0/65 (0.00%)  0
Pulmonary oedema  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Skin and subcutaneous tissue disorders       
Erythema  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Rash  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Vascular disorders       
Deep vein thrombosis  1  0/68 (0.00%)  0 1/71 (1.41%)  1 0/65 (0.00%)  0
Embolism  1  0/68 (0.00%)  0 0/71 (0.00%)  0 1/65 (1.54%)  1
Hypotension  1  1/68 (1.47%)  1 0/71 (0.00%)  0 1/65 (1.54%)  1
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo/Placebo Arm Demcizumab/Placebo Arm Demcizumab/Demcizumab Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   68/68 (100.00%)      71/71 (100.00%)      65/65 (100.00%)    
Blood and lymphatic system disorders       
Anaemia  1  27/68 (39.71%)  27 43/71 (60.56%)  43 35/65 (53.85%)  35
Thrombocytopenia  1  15/68 (22.06%)  15 14/71 (19.72%)  14 16/65 (24.62%)  16
Neutropenia  1  21/68 (30.88%)  21 24/71 (33.80%)  24 25/65 (38.46%)  25
Eye disorders       
Vision blurred  1  3/68 (4.41%)  3 3/71 (4.23%)  3 5/65 (7.69%)  5
Gastrointestinal disorders       
Nausea  1  42/68 (61.76%)  42 38/71 (53.52%)  38 41/65 (63.08%)  41
Diarrhoea  1  34/68 (50.00%)  34 41/71 (57.75%)  41 45/65 (69.23%)  45
Vomiting  1  27/68 (39.71%)  27 32/71 (45.07%)  32 25/65 (38.46%)  25
Constipation  1  20/68 (29.41%)  20 21/71 (29.58%)  21 28/65 (43.08%)  28
Abdominal pain  1  24/68 (35.29%)  24 16/71 (22.54%)  16 27/65 (41.54%)  27
Stomatitis  1  13/68 (19.12%)  13 12/71 (16.90%)  12 15/65 (23.08%)  15
Abdominal pain upper  1  13/68 (19.12%)  13 6/71 (8.45%)  6 8/65 (12.31%)  8
Dry mouth  1  7/68 (10.29%)  7 9/71 (12.68%)  9 6/65 (9.23%)  6
Ascites  1  9/68 (13.24%)  9 6/71 (8.45%)  6 3/65 (4.62%)  3
Gastrooesophageal reflux disease  1  6/68 (8.82%)  6 7/71 (9.86%)  7 5/65 (7.69%)  5
Abdominal distension  1  5/68 (7.35%)  5 4/71 (5.63%)  4 4/65 (6.15%)  4
Erythema  1  3/68 (4.41%)  3 7/71 (9.86%)  7 3/65 (4.62%)  3
Hypokalaemia  1  7/68 (10.29%)  7 7/71 (9.86%)  7 6/65 (9.23%)  6
General disorders       
Fatigue  1  34/68 (50.00%)  34 31/71 (43.66%)  31 37/65 (56.92%)  37
Oedema peripheral  1  29/68 (42.65%)  29 39/71 (54.93%)  39 34/65 (52.31%)  34
Pyrexia  1  24/68 (35.29%)  24 30/71 (42.25%)  30 23/65 (35.38%)  23
Asthenia  1  18/68 (26.47%)  18 27/71 (38.03%)  27 20/65 (30.77%)  20
Chills  1  6/68 (8.82%)  6 3/71 (4.23%)  3 8/65 (12.31%)  8
Headache  1  12/68 (17.65%)  12 13/71 (18.31%)  13 22/65 (33.85%)  22
Infections and infestations       
Urinary tract infection  1  7/68 (10.29%)  7 5/71 (7.04%)  5 7/65 (10.77%)  7
Upper respiratory tract infection  1  6/68 (8.82%)  6 6/71 (8.45%)  6 6/65 (9.23%)  6
Oral candidiasis  1  8/68 (11.76%)  8 2/71 (2.82%)  2 4/65 (6.15%)  4
Cellulitis  1  6/68 (8.82%)  6 5/71 (7.04%)  5 1/65 (1.54%)  1
Sepsis  1  3/68 (4.41%)  3 5/71 (7.04%)  5 4/65 (6.15%)  4
Investigations       
Platelet count decreased  1  16/68 (23.53%)  16 20/71 (28.17%)  20 13/65 (20.00%)  13
Alanine aminotransferase increased  1  16/68 (23.53%)  16 15/71 (21.13%)  15 15/65 (23.08%)  15
Neutrophil count decreased  1  16/68 (23.53%)  16 12/71 (16.90%)  12 12/65 (18.46%)  12
Aspartate aminotransferase increased  1  13/68 (19.12%)  13 5/71 (7.04%)  5 12/65 (18.46%)  12
Brain natriuretic peptide increased  1  5/68 (7.35%)  5 11/71 (15.49%)  11 14/65 (21.54%)  14
White blood cell count decreased  1  9/68 (13.24%)  9 4/71 (5.63%)  4 10/65 (15.38%)  10
Blood alkaline phosphatase increased  1  5/68 (7.35%)  5 6/71 (8.45%)  6 10/65 (15.38%)  10
Weight decreased  1  8/68 (11.76%)  8 5/71 (7.04%)  5 8/65 (12.31%)  8
Blood bilirubin increased  1  6/68 (8.82%)  6 3/71 (4.23%)  3 3/65 (4.62%)  3
Gamma-glutamyltransferase increased  1  5/68 (7.35%)  5 2/71 (2.82%)  2 5/65 (7.69%)  5
Metabolism and nutrition disorders       
Decreased appetite  1  19/68 (27.94%)  19 30/71 (42.25%)  30 27/65 (41.54%)  27
Hypoalbuminaemia  1  8/68 (11.76%)  8 10/71 (14.08%)  10 9/65 (13.85%)  9
Dehydration  1  6/68 (8.82%)  6 10/71 (14.08%)  10 6/65 (9.23%)  6
Hyperglycaemia  1  11/68 (16.18%)  11 5/71 (7.04%)  5 4/65 (6.15%)  4
Hyponatraemia  1  6/68 (8.82%)  6 4/71 (5.63%)  4 8/65 (12.31%)  8
Hypophosphataemia  1  5/68 (7.35%)  5 5/71 (7.04%)  5 6/65 (9.23%)  6
Hypocalcaemia  1  6/68 (8.82%)  6 7/71 (9.86%)  7 2/65 (3.08%)  2
Musculoskeletal and connective tissue disorders       
Back pain  1  16/68 (23.53%)  16 10/71 (14.08%)  10 13/65 (20.00%)  13
Myalgia  1  6/68 (8.82%)  6 10/71 (14.08%)  10 15/65 (23.08%)  15
Arthralgia  1  8/68 (11.76%)  8 9/71 (12.68%)  9 10/65 (15.38%)  10
Pain in extremity  1  8/68 (11.76%)  8 5/71 (7.04%)  5 7/65 (10.77%)  7
Musculoskeletal pain  1  3/68 (4.41%)  3 3/71 (4.23%)  3 6/65 (9.23%)  6
Muscular weakness  1  5/68 (7.35%)  5 2/71 (2.82%)  2 4/65 (6.15%)  4
Nervous system disorders       
Dysgeusia  1  18/68 (26.47%)  18 16/71 (22.54%)  16 17/65 (26.15%)  17
Peripheral sensory neuropathy  1  16/68 (23.53%)  16 17/71 (23.94%)  17 17/65 (26.15%)  17
Dizziness  1  10/68 (14.71%)  10 5/71 (7.04%)  5 7/65 (10.77%)  7
Neurotoxicity  1  2/68 (2.94%)  2 11/71 (15.49%)  11 4/65 (6.15%)  4
Psychiatric disorders       
Insomnia  1  9/68 (13.24%)  9 8/71 (11.27%)  8 9/65 (13.85%)  9
Anxiety  1  10/68 (14.71%)  10 5/71 (7.04%)  5 3/65 (4.62%)  3
Depression  1  6/68 (8.82%)  6 3/71 (4.23%)  3 7/65 (10.77%)  7
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  18/68 (26.47%)  18 16/71 (22.54%)  16 10/65 (15.38%)  10
Epistaxis  1  10/68 (14.71%)  10 13/71 (18.31%)  13 17/65 (26.15%)  17
Cough  1  10/68 (14.71%)  10 12/71 (16.90%)  12 11/65 (16.92%)  11
Dyspnoea exertional  1  3/68 (4.41%)  3 4/71 (5.63%)  4 8/65 (12.31%)  8
Pulmonary hypertension  1  1/68 (1.47%)  1 7/71 (9.86%)  7 7/65 (10.77%)  7
Rhinorrhoea  1  5/68 (7.35%)  5 2/71 (2.82%)  2 5/65 (7.69%)  5
Skin and subcutaneous tissue disorders       
Alopecia  1  30/68 (44.12%)  30 33/71 (46.48%)  33 28/65 (43.08%)  28
Rash  1  18/68 (26.47%)  18 14/71 (19.72%)  14 17/65 (26.15%)  17
Dry skin  1  4/68 (5.88%)  4 5/71 (7.04%)  5 5/65 (7.69%)  5
Rash maculo-papular  1  6/68 (8.82%)  6 3/71 (4.23%)  3 5/65 (7.69%)  5
Vascular disorders       
Hypertension  1  10/68 (14.71%)  10 17/71 (23.94%)  17 21/65 (32.31%)  21
Hypotension  1  11/68 (16.18%)  11 6/71 (8.45%)  6 5/65 (7.69%)  5
Deep vein thrombosis  1  7/68 (10.29%)  7 4/71 (5.63%)  4 9/65 (13.85%)  9
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
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: Manager, Regulatory Affairs
Organization: On
Phone: 6509958322
EMail: imran.chaudhry@oncomed.com
Layout table for additonal information
Responsible Party: Mereo BioPharma ( OncoMed Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT02289898    
Other Study ID Numbers: M18-006
First Submitted: November 10, 2014
First Posted: November 13, 2014
Results First Submitted: May 21, 2018
Results First Posted: August 8, 2018
Last Update Posted: August 12, 2020