YOSEMITE: 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
Sponsor
OncoMed Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02289898
Collaborator
Celgene Corporation (Industry)
207
42
3
28.4
4.9
0.2
Study Details
Study Description
Brief Summary
This is a randomized, double blind, 3 arm (1:1:1) study in subjects with 1st-line metastatic pancreatic ductal adenocarcinoma.
The purpose is to test the efficacy and safety of demcizumab, when given in combination with gemcitabine and Abraxane® compared to placebo. The administration of gemcitabine and Abraxane® is a standard treatment for patients with metastatic pancreatic ductal adenocarcinoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
207 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A 3-Arm Phase 2 Double-Blind Randomized 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
Actual Study Start Date
:
Apr 20, 2015
Actual Primary Completion Date
:
May 1, 2017
Actual Study Completion Date
:
Sep 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Abraxane® and gemcitabine plus placebo 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 |
Drug: Demcizumab
administered intravenously
Drug: Abraxane®
administered intravenously
Drug: gemcitabine
administered intravenously
Drug: Placebo
|
| Experimental: Abraxane® and gemcitabine plus demcizumab plus placebo 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 |
Drug: Demcizumab
administered intravenously
Drug: Abraxane®
administered intravenously
Drug: gemcitabine
administered intravenously
|
| Experimental: Abraxane® and gemcitabine plus demcizumab 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 |
Drug: Demcizumab
administered intravenously
Drug: Abraxane®
administered intravenously
Drug: gemcitabine
administered intravenously
|
Outcome Measures
Primary Outcome Measures
- Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms [Investigator-assessed progression-free survival time through duration of the study (2 years, 23 days).]
Investigator assessed Kaplan-Meier estimates of progression-free survival for placebo/placebo arm and pooled demcizumab arm.
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed.
-
Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue (from either the primary tumor, locoregional disease or a metastatic site), either fresh core-needle-biopsied or archived (two FFPE cores preferred whenever possible). If fresh tissue is obtained, the core biopsy must be done at least 7 days prior to randomization.
-
Age ≥21 years
-
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5. Measurable disease per RECIST v1.1
-
Adequate organ and marrow function
-
Signed Informed Consent Form
-
For women of childbearing potential, agreement to use two effective forms of contraception
Exclusion Criteria:
-
Subjects with a neuroendocrine tumor of the pancreas, an acinar tumor of the pancreas or a pancreatic tumor with mixed histologies.
-
Subjects receiving heparin, warfarin, factor Xa inhibitors or other similar anticoagulants. Note: Subjects may be receiving low-dose aspirin and/or non-steroidal anti-inflammatory agents.
-
Subjects with brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
-
Subjects with Grade >2 peripheral neuropathy
-
Subjects with clinically significant ascites
-
Malignancies other than pancreatic cancer successfully treated within 3 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, treated superficial bladder cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent
-
Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months
-
History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
-
Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
-
Pregnant women or nursing women
-
Subjects with known HIV infection
-
Known bleeding disorder or coagulopathy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Banner MD Anderson Cancer Center | Gilbert | Arizona | United States | 85234 |
| 2 | Providence Saint Joseph Medical Center | Burbank | California | United States | 91505 |
| 3 | City of Hope | Duarte | California | United States | 91010 |
| 4 | Scripps Cancer Center | La Jolla | California | United States | 92037 |
| 5 | University of California, Davis Comprehensive Cancer Center | Sacramento | California | United States | 95817 |
| 6 | Soulhern California Permanente Medical Group | San Marcos | California | United States | 92078 |
| 7 | Kaiser Permanente Medical Center | Vallejo | California | United States | 94589 |
| 8 | Rocky Mountain Cancer Centers | Denver | Colorado | United States | 80218 |
| 9 | Lynn Cancer Institute | Boca Raton | Florida | United States | 33486 |
| 10 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 11 | University of Kansas Cancer Center | Westwood | Kansas | United States | 66205 |
| 12 | Ochsner Clinic Foundation | New Orleans | Louisiana | United States | 70121 |
| 13 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
| 14 | Dartmouth Hitchcock Medical Center, Norris Cotton Cancer Center | Lebanon | New Hampshire | United States | 03756 |
| 15 | University of Rochester | Rochester | New York | United States | 14642 |
| 16 | SUNY Upstate Medical University | Syracuse | New York | United States | 13210 |
| 17 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 18 | Kaiser Permanente NW Oncology Research | Portland | Oregon | United States | 97227 |
| 19 | Thomas Jefferson University, Sydney Kimmel Cancer Center | Philadelphia | Pennsylvania | United States | 19107 |
| 20 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
| 21 | Joe Arrington Cancer Research Treatment Center | Lubbock | Texas | United States | 79410 |
| 22 | Huntsman Cancer Institute at The University of Utah | Salt Lake City | Utah | United States | 84112 |
| 23 | Prince of Wales Hospital | Randwick | New South Wales | Australia | 2031 |
| 24 | Monash Medical Centre, Moorabbin | Bentleigh East | Victoria | Australia | 3165 |
| 25 | Western Health (Sunshine Hospitals) | St Albans | Victoria | Australia | 3021 |
| 26 | St John of God Murdoch Hospital | Murdoch | Western Australia | Australia | 6150 |
| 27 | St. John of God Subiaco Hospital | Subiaco | Western Australia | Australia | 6008 |
| 28 | Hopital Erasme | Brussels | Brussels Capital | Belgium | 1070 |
| 29 | Tom Baker Cancer Centre | Calgary | Alberta | Canada | T2N 4N2 |
| 30 | British Columbia Cancer Agency | Vancouver | British Columbia | Canada | V5Z 4E6 |
| 31 | QEII Health Sciences Centre | Halifax | Nova Scotia | Canada | B3H 2Y9 |
| 32 | London Regional Cancer Program | London | Ontario | Canada | N6A 4L6 |
| 33 | Sunnybrook Health Sciences Centre, Odette Cancer Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 34 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
| 35 | St Josephs Health Centre | Toronto | Ontario | Canada | M6R 1B5 |
| 36 | Hospital Universitario de Fuenlabrada | Fuenlabrada | Madrid | Spain | 28492 |
| 37 | Hospital Universitari Germans Trias i Pujol - lnstituto Catalan d'Oncologia (!CO) | Barcelona | Spain | 08916 | |
| 38 | Hospital General Universitario Gregorio Marafi6n | Madrid | Spain | 28007 | |
| 39 | Hospital Universitario de Fuenlabrada | Madrid | Spain | 28942 | |
| 40 | Hospital Universitario Miguel Servet | Zaragoza | Spain | 50009 | |
| 41 | Bristol Haematology & Oncology Centre | Bristol | United Kingdom | BS2 8ED | |
| 42 | Sarah Cannon Research Institute UK | London | United Kingdom | W1G 6AD |
Sponsors and Collaborators
- OncoMed Pharmaceuticals, Inc.
- Celgene Corporation
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02289898
Other Study ID Numbers:
- M18-006
First Posted:
Nov 13, 2014
Last Update Posted:
Sep 28, 2020
Last Verified:
Sep 1, 2020
Keywords provided by OncoMed Pharmaceuticals, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 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 |
|---|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | Placebo/Placebo Arm | Demcizumab/Placebo Arm | Demcizumab/Demcizumab Arm | Total |
|---|---|---|---|---|
| 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 Participants | 68 | 71 | 65 | 204 |
| Age (Count of Participants) | ||||
| <=18 years |
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 (years) [Median (Full Range) ] | ||||
| Median (Full Range) [years] |
62
|
63
|
66
|
63
|
| Sex: Female, Male (Count of 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) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
1
1.5%
|
1
0.5%
|
| Asian |
1
1.5%
|
0
0%
|
1
1.5%
|
2
1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
1
1.4%
|
0
0%
|
1
0.5%
|
| Black or African American |
1
1.5%
|
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%
|
| Unknown or Not Reported |
6
8.8%
|
0
0%
|
1
1.5%
|
7
3.4%
|
| Region of Enrollment (Count of Participants) | ||||
| Canada |
3
4.4%
|
5
7%
|
4
6.2%
|
12
5.9%
|
| Belgium |
2
2.9%
|
2
2.8%
|
2
3.1%
|
6
2.9%
|
| United States |
17
25%
|
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%
|
Outcome Measures
| Title | Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms |
|---|---|
| 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). |
Outcome Measure Data
| Analysis Population Description |
|---|
| Placebo/placebo arm and pooled demcizumab arms (ITT population). |
| Arm/Group Title | Placebo/Placebo Arm | Demcizumab/Placebo and Demcizumab/Demcizumab |
|---|---|---|
| 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. |
| Measure Participants | 68 | 136 |
| Progressed (event) |
38
55.9%
|
70
98.6%
|
| Died (event) |
5
7.4%
|
12
16.9%
|
| Censored, follow-up ended |
3
4.4%
|
7
9.9%
|
| Censored, follow-up ongoing |
22
32.4%
|
47
66.2%
|
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 | ||
| Statistical Test of Hypothesis | p-Value | =0.7158 |
| Comments | ||
| Method | Wilcoxon (Mann-Whitney) | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | .930 | |
| Confidence Interval |
(2-Sided) 95% 0.630 to 1.375 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| 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 | ||||||
| Arm/Group Title | Placebo/Placebo Arm | Demcizumab/Placebo Arm | Demcizumab/Demcizumab Arm | |||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/68 (7.4%) | 12/71 (16.9%) | 3/65 (4.6%) | |||
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 (58.8%) | 49/71 (69%) | 34/65 (52.3%) | |||
| Blood and lymphatic system disorders | ||||||
| Febrile neutropenia | 4/68 (5.9%) | 4 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Anaemia | 3/68 (4.4%) | 3 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Neutropenia | 1/68 (1.5%) | 1 | 1/71 (1.4%) | 1 | 2/65 (3.1%) | 2 |
| Haemolytic anaemia | 0/68 (0%) | 0 | 2/71 (2.8%) | 2 | 0/65 (0%) | 0 |
| Haemolytic uraemic syndrome | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 1/65 (1.5%) | 1 |
| Pancytopenia | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 2/65 (3.1%) | 2 |
| Thrombotic thrombocytopenic purpura | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 2/65 (3.1%) | 2 |
| Iron deficiency anaemia | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Thrombocytopenia | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Cardiac disorders | ||||||
| Cardiac failure | 0/68 (0%) | 0 | 2/71 (2.8%) | 2 | 1/65 (1.5%) | 1 |
| Angina pectoris | 0/68 (0%) | 0 | 2/71 (2.8%) | 2 | 0/65 (0%) | 0 |
| Atrial fibrillation | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 1/65 (1.5%) | 1 |
| Acute myocardial infarction | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Cardiac arrest | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Cardiac failure congestive | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Ear and labyrinth disorders | ||||||
| Vertigo | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Papilloedema | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Gastrointestinal disorders | ||||||
| Vomiting | 5/68 (7.4%) | 5 | 4/71 (5.6%) | 4 | 5/65 (7.7%) | 5 |
| Diarrhoea | 1/68 (1.5%) | 1 | 4/71 (5.6%) | 4 | 3/65 (4.6%) | 3 |
| Abdominal pain | 4/68 (5.9%) | 4 | 0/71 (0%) | 0 | 3/65 (4.6%) | 3 |
| Nausea | 4/68 (5.9%) | 4 | 1/71 (1.4%) | 1 | 2/65 (3.1%) | 2 |
| Gastrointestinal haemorrhage | 0/68 (0%) | 0 | 2/71 (2.8%) | 2 | 2/65 (3.1%) | 2 |
| Ascites | 1/68 (1.5%) | 1 | 2/71 (2.8%) | 2 | 0/65 (0%) | 0 |
| Abdominal pain upper | 1/68 (1.5%) | 1 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Colitis | 1/68 (1.5%) | 1 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Enterocolitis | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 1/65 (1.5%) | 1 |
| Gastritis | 0/68 (0%) | 0 | 2/71 (2.8%) | 2 | 0/65 (0%) | 0 |
| Intestinal obstruction | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 1/65 (1.5%) | 1 |
| Small intestinal haemorrhage | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 1/65 (1.5%) | 1 |
| Upper gastrointestinal haemorrhage | 0/68 (0%) | 0 | 2/71 (2.8%) | 2 | 0/65 (0%) | 0 |
| Anal fissure | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Colonic fistula | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Constipation | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Diverticular perforation | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Duodenal ulcer | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Gastric haemorrhage | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Haematemesis | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Ileus | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Intestinal stenosis | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Intra-abdominal haemorrhage | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Large intestinal obstruction | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Pancreatic duct obstruction | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Pancreatic insufficiency | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| General disorders | ||||||
| Pyrexia | 6/68 (8.8%) | 6 | 3/71 (4.2%) | 3 | 6/65 (9.2%) | 6 |
| Chest discomfort | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Multiple organ dysfunction syndrome | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Peripheral swelling | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Systemic inflammatory response syndrome | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Hepatobiliary disorders | ||||||
| Jaundice cholestatic | 1/68 (1.5%) | 1 | 1/71 (1.4%) | 1 | 1/65 (1.5%) | 1 |
| Cholangitis | 1/68 (1.5%) | 1 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Bile duct obstruction | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Bile duct stenosis | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Cholecystitis acute | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Cholestasis | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Hepatic haematoma | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Hyperbilirubinaemia | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Jaundice | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Portal vein thrombosis | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Infections and infestations | ||||||
| Sepsis | 3/68 (4.4%) | 3 | 4/71 (5.6%) | 4 | 4/65 (6.2%) | 4 |
| Liver abscess | 2/68 (2.9%) | 2 | 2/71 (2.8%) | 2 | 0/65 (0%) | 0 |
| Urinary tract infection | 2/68 (2.9%) | 2 | 1/71 (1.4%) | 1 | 1/65 (1.5%) | 1 |
| Cellulitis | 1/68 (1.5%) | 1 | 2/71 (2.8%) | 2 | 0/65 (0%) | 0 |
| Pneumonia | 2/68 (2.9%) | 2 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Urosepsis | 2/68 (2.9%) | 2 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Abdominal abscess | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Bacteraemia | 0/68 (0%) | 0 | 2/71 (2.8%) | 2 | 0/65 (0%) | 0 |
| Lower respiratory tract infection | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Neutropenic sepsis | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 1/65 (1.5%) | 1 |
| Bacterial infection | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Bacterial sepsis | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Bronchitis | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Colonic abscess | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Cystitis | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Device related infection | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Escherichia bacteraemia | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Hepatic infection | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Infection | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Lung infection | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Tick-borne fever | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Pyelonephritis acute | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Septic shock | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Upper respiratory tract infection | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Fall | 2/68 (2.9%) | 2 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Toxicity to various agents | 1/68 (1.5%) | 1 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Anaesthetic complication | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Hip fracture | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Procedural pain | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Investigations | ||||||
| Blood bilirubin increased | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Liver function test increased | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Neutrophil count decreased | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Transaminases increased | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| White blood cell count decreased | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Metabolism and nutrition disorders | ||||||
| Dehydration | 2/68 (2.9%) | 2 | 3/71 (4.2%) | 3 | 2/65 (3.1%) | 2 |
| Hyponatraemia | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 2/65 (3.1%) | 2 |
| Food intolerance | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Hyperglycaemia | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Hypophosphataemia | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 2/68 (2.9%) | 2 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Myalgia | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Vertebral lesion | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Cancer pain | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Hepatic neoplasm | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Metastases to central nervous system | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Tumour rupture | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Nervous system disorders | ||||||
| Syncope | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Transient ischaemic attack | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 1/65 (1.5%) | 1 |
| Cerebral haemorrhage | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Cerebral infarction | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Cerebrovascular accident | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Generalised tonic-clonic seizure | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Peroneal nerve palsy | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Presyncope | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Product Issues | ||||||
| Device dislocation | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Psychiatric disorders | ||||||
| Anxiety | 1/68 (1.5%) | 1 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Confusional state | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Delirium | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Mental status changes | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Renal and urinary disorders | ||||||
| Acute kidney injury | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 3/65 (4.6%) | 3 |
| Renal failure | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Renal injury | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 2/68 (2.9%) | 2 | 2/71 (2.8%) | 2 | 0/65 (0%) | 0 |
| Pleural effusion | 2/68 (2.9%) | 2 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Pulmonary embolism | 2/68 (2.9%) | 2 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Pulmonary hypertension | 0/68 (0%) | 0 | 2/71 (2.8%) | 2 | 0/65 (0%) | 0 |
| Respiratory failure | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Acute respiratory distress syndrome | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Orthopnoea | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Pneumonitis | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Pneumothorax | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 0/65 (0%) | 0 |
| Pulmonary oedema | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| Erythema | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Rash | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Vascular disorders | ||||||
| Deep vein thrombosis | 0/68 (0%) | 0 | 1/71 (1.4%) | 1 | 0/65 (0%) | 0 |
| Embolism | 0/68 (0%) | 0 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
| Hypotension | 1/68 (1.5%) | 1 | 0/71 (0%) | 0 | 1/65 (1.5%) | 1 |
Other (Not Including 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 | 68/68 (100%) | 71/71 (100%) | 65/65 (100%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 27/68 (39.7%) | 27 | 43/71 (60.6%) | 43 | 35/65 (53.8%) | 35 |
| Thrombocytopenia | 15/68 (22.1%) | 15 | 14/71 (19.7%) | 14 | 16/65 (24.6%) | 16 |
| Neutropenia | 21/68 (30.9%) | 21 | 24/71 (33.8%) | 24 | 25/65 (38.5%) | 25 |
| Eye disorders | ||||||
| Vision blurred | 3/68 (4.4%) | 3 | 3/71 (4.2%) | 3 | 5/65 (7.7%) | 5 |
| Gastrointestinal disorders | ||||||
| Nausea | 42/68 (61.8%) | 42 | 38/71 (53.5%) | 38 | 41/65 (63.1%) | 41 |
| Diarrhoea | 34/68 (50%) | 34 | 41/71 (57.7%) | 41 | 45/65 (69.2%) | 45 |
| Vomiting | 27/68 (39.7%) | 27 | 32/71 (45.1%) | 32 | 25/65 (38.5%) | 25 |
| Constipation | 20/68 (29.4%) | 20 | 21/71 (29.6%) | 21 | 28/65 (43.1%) | 28 |
| Abdominal pain | 24/68 (35.3%) | 24 | 16/71 (22.5%) | 16 | 27/65 (41.5%) | 27 |
| Stomatitis | 13/68 (19.1%) | 13 | 12/71 (16.9%) | 12 | 15/65 (23.1%) | 15 |
| Abdominal pain upper | 13/68 (19.1%) | 13 | 6/71 (8.5%) | 6 | 8/65 (12.3%) | 8 |
| Dry mouth | 7/68 (10.3%) | 7 | 9/71 (12.7%) | 9 | 6/65 (9.2%) | 6 |
| Ascites | 9/68 (13.2%) | 9 | 6/71 (8.5%) | 6 | 3/65 (4.6%) | 3 |
| Gastrooesophageal reflux disease | 6/68 (8.8%) | 6 | 7/71 (9.9%) | 7 | 5/65 (7.7%) | 5 |
| Abdominal distension | 5/68 (7.4%) | 5 | 4/71 (5.6%) | 4 | 4/65 (6.2%) | 4 |
| Erythema | 3/68 (4.4%) | 3 | 7/71 (9.9%) | 7 | 3/65 (4.6%) | 3 |
| Hypokalaemia | 7/68 (10.3%) | 7 | 7/71 (9.9%) | 7 | 6/65 (9.2%) | 6 |
| General disorders | ||||||
| Fatigue | 34/68 (50%) | 34 | 31/71 (43.7%) | 31 | 37/65 (56.9%) | 37 |
| Oedema peripheral | 29/68 (42.6%) | 29 | 39/71 (54.9%) | 39 | 34/65 (52.3%) | 34 |
| Pyrexia | 24/68 (35.3%) | 24 | 30/71 (42.3%) | 30 | 23/65 (35.4%) | 23 |
| Asthenia | 18/68 (26.5%) | 18 | 27/71 (38%) | 27 | 20/65 (30.8%) | 20 |
| Chills | 6/68 (8.8%) | 6 | 3/71 (4.2%) | 3 | 8/65 (12.3%) | 8 |
| Headache | 12/68 (17.6%) | 12 | 13/71 (18.3%) | 13 | 22/65 (33.8%) | 22 |
| Infections and infestations | ||||||
| Urinary tract infection | 7/68 (10.3%) | 7 | 5/71 (7%) | 5 | 7/65 (10.8%) | 7 |
| Upper respiratory tract infection | 6/68 (8.8%) | 6 | 6/71 (8.5%) | 6 | 6/65 (9.2%) | 6 |
| Oral candidiasis | 8/68 (11.8%) | 8 | 2/71 (2.8%) | 2 | 4/65 (6.2%) | 4 |
| Cellulitis | 6/68 (8.8%) | 6 | 5/71 (7%) | 5 | 1/65 (1.5%) | 1 |
| Sepsis | 3/68 (4.4%) | 3 | 5/71 (7%) | 5 | 4/65 (6.2%) | 4 |
| Investigations | ||||||
| Platelet count decreased | 16/68 (23.5%) | 16 | 20/71 (28.2%) | 20 | 13/65 (20%) | 13 |
| Alanine aminotransferase increased | 16/68 (23.5%) | 16 | 15/71 (21.1%) | 15 | 15/65 (23.1%) | 15 |
| Neutrophil count decreased | 16/68 (23.5%) | 16 | 12/71 (16.9%) | 12 | 12/65 (18.5%) | 12 |
| Aspartate aminotransferase increased | 13/68 (19.1%) | 13 | 5/71 (7%) | 5 | 12/65 (18.5%) | 12 |
| Brain natriuretic peptide increased | 5/68 (7.4%) | 5 | 11/71 (15.5%) | 11 | 14/65 (21.5%) | 14 |
| White blood cell count decreased | 9/68 (13.2%) | 9 | 4/71 (5.6%) | 4 | 10/65 (15.4%) | 10 |
| Blood alkaline phosphatase increased | 5/68 (7.4%) | 5 | 6/71 (8.5%) | 6 | 10/65 (15.4%) | 10 |
| Weight decreased | 8/68 (11.8%) | 8 | 5/71 (7%) | 5 | 8/65 (12.3%) | 8 |
| Blood bilirubin increased | 6/68 (8.8%) | 6 | 3/71 (4.2%) | 3 | 3/65 (4.6%) | 3 |
| Gamma-glutamyltransferase increased | 5/68 (7.4%) | 5 | 2/71 (2.8%) | 2 | 5/65 (7.7%) | 5 |
| Metabolism and nutrition disorders | ||||||
| Decreased appetite | 19/68 (27.9%) | 19 | 30/71 (42.3%) | 30 | 27/65 (41.5%) | 27 |
| Hypoalbuminaemia | 8/68 (11.8%) | 8 | 10/71 (14.1%) | 10 | 9/65 (13.8%) | 9 |
| Dehydration | 6/68 (8.8%) | 6 | 10/71 (14.1%) | 10 | 6/65 (9.2%) | 6 |
| Hyperglycaemia | 11/68 (16.2%) | 11 | 5/71 (7%) | 5 | 4/65 (6.2%) | 4 |
| Hyponatraemia | 6/68 (8.8%) | 6 | 4/71 (5.6%) | 4 | 8/65 (12.3%) | 8 |
| Hypophosphataemia | 5/68 (7.4%) | 5 | 5/71 (7%) | 5 | 6/65 (9.2%) | 6 |
| Hypocalcaemia | 6/68 (8.8%) | 6 | 7/71 (9.9%) | 7 | 2/65 (3.1%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 16/68 (23.5%) | 16 | 10/71 (14.1%) | 10 | 13/65 (20%) | 13 |
| Myalgia | 6/68 (8.8%) | 6 | 10/71 (14.1%) | 10 | 15/65 (23.1%) | 15 |
| Arthralgia | 8/68 (11.8%) | 8 | 9/71 (12.7%) | 9 | 10/65 (15.4%) | 10 |
| Pain in extremity | 8/68 (11.8%) | 8 | 5/71 (7%) | 5 | 7/65 (10.8%) | 7 |
| Musculoskeletal pain | 3/68 (4.4%) | 3 | 3/71 (4.2%) | 3 | 6/65 (9.2%) | 6 |
| Muscular weakness | 5/68 (7.4%) | 5 | 2/71 (2.8%) | 2 | 4/65 (6.2%) | 4 |
| Nervous system disorders | ||||||
| Dysgeusia | 18/68 (26.5%) | 18 | 16/71 (22.5%) | 16 | 17/65 (26.2%) | 17 |
| Peripheral sensory neuropathy | 16/68 (23.5%) | 16 | 17/71 (23.9%) | 17 | 17/65 (26.2%) | 17 |
| Dizziness | 10/68 (14.7%) | 10 | 5/71 (7%) | 5 | 7/65 (10.8%) | 7 |
| Neurotoxicity | 2/68 (2.9%) | 2 | 11/71 (15.5%) | 11 | 4/65 (6.2%) | 4 |
| Psychiatric disorders | ||||||
| Insomnia | 9/68 (13.2%) | 9 | 8/71 (11.3%) | 8 | 9/65 (13.8%) | 9 |
| Anxiety | 10/68 (14.7%) | 10 | 5/71 (7%) | 5 | 3/65 (4.6%) | 3 |
| Depression | 6/68 (8.8%) | 6 | 3/71 (4.2%) | 3 | 7/65 (10.8%) | 7 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnoea | 18/68 (26.5%) | 18 | 16/71 (22.5%) | 16 | 10/65 (15.4%) | 10 |
| Epistaxis | 10/68 (14.7%) | 10 | 13/71 (18.3%) | 13 | 17/65 (26.2%) | 17 |
| Cough | 10/68 (14.7%) | 10 | 12/71 (16.9%) | 12 | 11/65 (16.9%) | 11 |
| Dyspnoea exertional | 3/68 (4.4%) | 3 | 4/71 (5.6%) | 4 | 8/65 (12.3%) | 8 |
| Pulmonary hypertension | 1/68 (1.5%) | 1 | 7/71 (9.9%) | 7 | 7/65 (10.8%) | 7 |
| Rhinorrhoea | 5/68 (7.4%) | 5 | 2/71 (2.8%) | 2 | 5/65 (7.7%) | 5 |
| Skin and subcutaneous tissue disorders | ||||||
| Alopecia | 30/68 (44.1%) | 30 | 33/71 (46.5%) | 33 | 28/65 (43.1%) | 28 |
| Rash | 18/68 (26.5%) | 18 | 14/71 (19.7%) | 14 | 17/65 (26.2%) | 17 |
| Dry skin | 4/68 (5.9%) | 4 | 5/71 (7%) | 5 | 5/65 (7.7%) | 5 |
| Rash maculo-papular | 6/68 (8.8%) | 6 | 3/71 (4.2%) | 3 | 5/65 (7.7%) | 5 |
| Vascular disorders | ||||||
| Hypertension | 10/68 (14.7%) | 10 | 17/71 (23.9%) | 17 | 21/65 (32.3%) | 21 |
| Hypotension | 11/68 (16.2%) | 11 | 6/71 (8.5%) | 6 | 5/65 (7.7%) | 5 |
| Deep vein thrombosis | 7/68 (10.3%) | 7 | 4/71 (5.6%) | 4 | 9/65 (13.8%) | 9 |
Limitations/Caveats
[Not Specified]
More Information
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
| Name/Title | John, Lewicki, Chief Scientific Officer |
|---|---|
| Organization | Mereo BioPharma Group Plc. |
| Phone | +44333023300 |
| John.Lewicki@mereobiopharma.com |
Responsible Party:
OncoMed Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02289898
Other Study ID Numbers:
- M18-006
First Posted:
Nov 13, 2014
Last Update Posted:
Sep 28, 2020
Last Verified:
Sep 1, 2020