Recombinant Vaccinia Virus Administered Intravenously in Patients With Metastatic, Refractory Colorectal Carcinoma
Sponsor
Jennerex Biotherapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT01394939
Collaborator
Transgene (Industry)
52
11
4
45
4.7
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of JX-594 (Pexa-Vec) administered intravenously either alone or in combination with Irinotecan in colorectal carcinoma patients who are refractory to or intolerant to standard therapy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
This was a Phase 1/2a, open-label, dose-escalation study in patients with advanced colorectal cancer (CRC)
Study Design
Study Type:
Interventional
Actual Enrollment
:
52 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1/2a Dose-escalation Study of JX 594 Administered by Multiple Intravenous (IV) Infusions Alone and in Combination With Irinotecan in Patients With Metastatic, Refractory Colorectal Carcinoma.
Study Start Date
:
Jan 1, 2012
Actual Primary Completion Date
:
Jun 1, 2015
Actual Study Completion Date
:
Oct 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Single Agent_ Cohort 1 JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594: Recombinant Vaccinia Granulocyte-Macrophage Colony-Stimulating Factor (RAC VAC GM-CSF) Cohort 1: JX-594 3 x 10^8 plaque forming unit (pfu), Days 1, 8,15, 22, and 29 |
Biological: JX-594
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
|
| Experimental: Single Agent_Cohort 2 JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594: RAC VAC GM-CSF Cohort 2: JX-594 1 x 10^9 pfu, Days 1, 8,15, 22, and 29 |
Biological: JX-594
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
|
| Experimental: Combination_Cohort 3 JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594: RAC VAC GM-CSF Irinotecan: 180 mg/m2 IV every 2 weeks. JX-594 3 x 10^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. |
Biological: JX-594
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Drug: Irinotecan
180 mg/m2 IV every 2 weeks.
|
| Experimental: Combination_Cohort 4 JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594: RAC VAC GM-CSF JX-594 1 x 10^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. |
Biological: JX-594
Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
Drug: Irinotecan
180 mg/m2 IV every 2 weeks.
|
Outcome Measures
Primary Outcome Measures
- Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study [Scans Every 8 weeks until radiographic progression was confirmed by the site.]
Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), >=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Histologically-confirmed, advanced metastatic colorectal cancer failed treatment with fluoropyrimidine (fluoruracil or capecitabine) and oxaliplatin based therapies or had contradictions to treatment with these drugs as determined by the investigator
-
Failed treatment with irinotecan
-
Kras mutant tumor or Kras wild-type having failed cetuximab (Erbitux) or panitumumab (Vectibix) or had contradictions to treatment
-
Regorafenib-naïve (have not received regorafenib)
-
Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
-
Measurable tumor (≥1 cm longest diameter)
-
Acceptable health status as determined by the investigator and blood work (Chemistry, Complete Blood Count, Coagulation)
Exclusion Criteria:
-
Intolerant to Irinotecan (if assigned to the combination arm: Cohort 3, Cohort 4 or Combination Expansion Arm)
-
Treatment with ketoconazole, enzyme-inducing anticonvulsants and St. John's Wort (if assigned to combination arm)
-
Significant immunodeficiency due to underlying illness and/or medication
-
History of severe exfoliative skin condition requiring systemic therapy within the past 2 years
-
Clinically significant and/or rapidly accumulating ascites, pericardial and/or pleural effusions
-
Active cardiovascular disease, including but not limited to significant coronary artery disease (e.g., requiring angioplasty or stenting) or congestive heart failure within the preceding 12 months
-
Viable Centrual Nervous System (CNS) malignancy associated with clinical symptoms
-
Received anti-cancer therapy within 4 weeks prior to first treatment (6 weeks for mitomycin c or nitrosoureas)
-
Prior participation in any other research protocol involving an investigational medicinal product within 4 weeks prior to first treatment
-
Use of prohibited anti-viral medication, interferon/pegylated interferon (PEG-IFN) or ribavirin that cannot be discontinued within 14 days prior to any JX 594 dose
-
Inability to suspend treatment with anti-hypertensive medication for 48 hours prior to and 48 hours after all JX-594 treatments.
-
Pregnant or nursing an infant
-
Diagnosis of chronic inflammatory bowel disease and/or bowel obstruction.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mayo Clinic | Scottsdale | Arizona | United States | 85259-5499 |
| 2 | UCSD Moores Cancer Center | La Jolla | California | United States | 92093 |
| 3 | Billings Clinic Cancer Center | Billings | Montana | United States | 59101 |
| 4 | University of North Carolina | Chapel Hill | North Carolina | United States | 27599-1651 |
| 5 | Gabrail Cancer Center | Canton | Ohio | United States | 44718 |
| 6 | The Ohio State University | Columbus | Ohio | United States | 43210 |
| 7 | Juravinski Cancer Centre | Hamilton | Ontario | Canada | L8V 5C2 |
| 8 | Ottawa Hospital and Research Institute (OHRI) | Ottawa | Ontario | Canada | K1H 8L6 |
| 9 | Hôpital Saint Antoine | Paris | France | 75012 | |
| 10 | Hôpital Hautepierre | Strasbourg | France | 67200 | |
| 11 | Institut Claudius Regaud | Toulouse | France | 31052 |
Sponsors and Collaborators
- Jennerex Biotherapeutics
- Transgene
Investigators
- Study Director: James Burke, MD, Jennerex Biotherapeutics
- Principal Investigator: Derek Jonker, MD, Ottawa Hospital and Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Jennerex Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01394939
Other Study ID Numbers:
- JX594-CRC019
First Posted:
Jul 15, 2011
Last Update Posted:
Jan 8, 2021
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jennerex Biotherapeutics
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | 2 patients out of 52 enrolled experienced no study related Adverse Event (AE) and was not included in the started population. |
| Arm/Group Title | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 |
|---|---|---|---|---|
| Arm/Group Description | JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. Cohort 1: JX-594 3 x 10^8 pfu, Days 1, 8,15, 22, and 29 | JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. Cohort 2: JX-594 1 x 10^9 pfu, Days 1, 8,15, 22, and 29 | JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. Irinotecan: 180 mg/m2 IV every 2 weeks. JX-594 3 x 10^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. | JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594 1 x 10^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. |
| Period Title: Overall Study | ||||
| STARTED | 4 | 25 | 4 | 17 |
| COMPLETED | 3 | 15 | 4 | 10 |
| NOT COMPLETED | 1 | 10 | 0 | 7 |
Baseline Characteristics
| Arm/Group Title | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 | Total |
|---|---|---|---|---|---|
| Arm/Group Description | JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594 3 x 10^8 pfu, Days 1, 8,15, 22, and 29 | JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594 1 x 10^9 pfu, Days 1, 8,15, 22, and 29 | JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594 3 x 10^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. | JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594 1 x 10^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. | Total of all reporting groups |
| Overall Participants | 4 | 25 | 4 | 17 | 50 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
3
75%
|
15
60%
|
3
75%
|
10
58.8%
|
31
62%
|
| >=65 years |
1
25%
|
10
40%
|
1
25%
|
7
41.2%
|
19
38%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
64.3
(8.06)
|
58.3
(11.84)
|
58.8
(13.74)
|
58.6
(10.42)
|
58.9
(11.05)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
0
0%
|
13
52%
|
1
25%
|
6
35.3%
|
20
40%
|
| Male |
4
100%
|
12
48%
|
3
75%
|
11
64.7%
|
30
60%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
1
2%
|
| Not Hispanic or Latino |
4
100%
|
25
100%
|
4
100%
|
15
88.2%
|
48
96%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
1
2%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
2
11.8%
|
2
4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
3
17.6%
|
3
6%
|
| White |
4
100%
|
25
100%
|
4
100%
|
11
64.7%
|
44
88%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
1
2%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Determine Radiographic Response Rate of Patients Enrolled in the Phase 2a Portion of the Study |
|---|---|
| Description | Percentage of participants who showed overall response during their participation in the study. Per Modified Response Evaluation Criteria In Solid Tumors Criteria (mRECIST) and assessed by tri-phasic contrast enhanced CT: Complete Response (CR), Disappearance of intratumoral enhancing area; Partial Response (PR), >=30% decrease in the sum of the diameters of enhancing area; Overall Response (OR) = CR + PR. |
| Time Frame | Scans Every 8 weeks until radiographic progression was confirmed by the site. |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 |
|---|---|---|---|---|
| Arm/Group Description | JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. Cohort 1: JX-594 3 x 10^8 pfu, Days 1, 8,15, 22, and 29 | JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594 1 x 10^9 pfu, Days 1, 8,15, 22, and 29 | JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594 3 x 10^8 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. | JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594 1 x 10^9 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. |
| Measure Participants | 4 | 25 | 4 | 17 |
| Count of Participants [Participants] |
0
0%
|
0
0%
|
0
0%
|
1
5.9%
|
Adverse Events
| Time Frame | 2 years | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 | ||||
| Arm/Group Description | JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) Cohort 1: Pexa-Vec 3 x 108 pfu, Days 1, 8,15, 22, and 29 | JX-594 administered intravenously weekly for 5 weeks followed by up to 3 additional intravenous infusion boosts. JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) Cohort 2: Pexa-Vec 3 x 109 pfu, Days 1, 8,15, 22, and 29 | JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) Irinotecan: 180 mg/m2 IV every 2 weeks. Cohort 3: Pexa-Vec 3 x 108 pfu Day 1,8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. | JX-594 administered intravenously weekly for 5 weeks followed by up to three additional intravenous infusion boosts in combination with Irinotecan administered every 14 days beginning at Day 9. JX-594: Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594) Cohort 4: Pexa-Vec 1 x 109 pfu Day1, 8, 15, 22, 29 + irinotecan 180 mg/m2 biweekly starts on Day 9. | ||||
All Cause Mortality |
||||||||
| Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 0/17 (0%) | ||||
Serious Adverse Events |
||||||||
| Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/4 (50%) | 10/25 (40%) | 1/4 (25%) | 8/17 (47.1%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Abdominal pain upper | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Diarrhoea | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Duodenal perforation | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Ileus | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 0/17 (0%) | ||||
| Small intestinal obstruction | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| General disorders | ||||||||
| Disease progression | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 0/17 (0%) | ||||
| General physical health deterioration | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Pyrexia | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Hepatobiliary disorders | ||||||||
| Bile duct stenosis | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Hepatic failure | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Immune system disorders | ||||||||
| Drug hypersensitivity | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Infections and infestations | ||||||||
| Biliary tract infection | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Clostridium difficile colitis | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Pelvic infection | 0/4 (0%) | 0/25 (0%) | 1/4 (25%) | 0/17 (0%) | ||||
| Sepsis | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Urinary tract infection bacterial | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Investigations | ||||||||
| Blood bilirubin increased | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Troponin increased | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Dehydration | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Hyponatraemia | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Bone pain | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Flank pain | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Muscular weakness | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Cancer pain | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Metastases to central nervous system | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Metastatic pain | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Vascular disorders | ||||||||
| Aortic stenosis | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Single Agent_ Cohort 1 | Single Agent_Cohort 2 | Combination_Cohort 3 | Combination_Cohort 4 | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 4/4 (100%) | 25/25 (100%) | 4/4 (100%) | 17/17 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 0/4 (0%) | 6/25 (24%) | 2/4 (50%) | 6/17 (35.3%) | ||||
| Leukocytosis | 0/4 (0%) | 0/25 (0%) | 2/4 (50%) | 1/17 (5.9%) | ||||
| Leukopenia | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Lymphadenopathy | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Neutropenia | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 3/17 (17.6%) | ||||
| Thrombocytopenia | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 2/17 (11.8%) | ||||
| Cardiac disorders | ||||||||
| Bradycardia | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Sinus tachycardia | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Tachycardia | 2/4 (50%) | 6/25 (24%) | 3/4 (75%) | 7/17 (41.2%) | ||||
| Ventricular hypokinesia | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Eye disorders | ||||||||
| Eyepain | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Ocular icterus | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal distension | 1/4 (25%) | 4/25 (16%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Abdominal pain | 3/4 (75%) | 7/25 (28%) | 2/4 (50%) | 5/17 (29.4%) | ||||
| Abdominal pain lower | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Abdominal pain upper | 0/4 (0%) | 3/25 (12%) | 3/4 (75%) | 1/17 (5.9%) | ||||
| Ascites | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Constipation | 1/4 (25%) | 3/25 (12%) | 2/4 (50%) | 5/17 (29.4%) | ||||
| Diarrhoea | 0/4 (0%) | 3/25 (12%) | 2/4 (50%) | 8/17 (47.1%) | ||||
| Dry mouth | 0/4 (0%) | 0/25 (0%) | 1/4 (25%) | 0/17 (0%) | ||||
| Duodenal perforation | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Dyspepsia | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 0/17 (0%) | ||||
| Flatulence | 0/4 (0%) | 1/25 (4%) | 1/4 (25%) | 0/17 (0%) | ||||
| Gastrooesophageal reflux disease | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Haemorrhoids | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Ileus | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 0/17 (0%) | ||||
| Lip dry | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Nausea | 4/4 (100%) | 13/25 (52%) | 4/4 (100%) | 14/17 (82.4%) | ||||
| Oral pain | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Proctalgia | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Salivary hypersecretion | 0/4 (0%) | 0/25 (0%) | 1/4 (25%) | 0/17 (0%) | ||||
| Small intestinal obstruction | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Stomatitis | 0/4 (0%) | 1/25 (4%) | 2/4 (50%) | 1/17 (5.9%) | ||||
| Vomiting | 1/4 (25%) | 12/25 (48%) | 4/4 (100%) | 10/17 (58.8%) | ||||
| General disorders | ||||||||
| Asthenia | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 0/17 (0%) | ||||
| Catheter site pruritus | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Chills | 4/4 (100%) | 19/25 (76%) | 4/4 (100%) | 15/17 (88.2%) | ||||
| Device occlusion | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Disease progression | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 0/17 (0%) | ||||
| Fatigue | 2/4 (50%) | 7/25 (28%) | 4/4 (100%) | 12/17 (70.6%) | ||||
| General physical health deterioration | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Hypothermia | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Influenza like illness | 0/4 (0%) | 2/25 (8%) | 1/4 (25%) | 0/17 (0%) | ||||
| Injection site pain | 1/4 (25%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Localised oedema | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Malaise | 0/4 (0%) | 1/25 (4%) | 2/4 (50%) | 0/17 (0%) | ||||
| Mass | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Medical device complication | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Mucosal inflammation | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 3/17 (17.6%) | ||||
| Oedema peripheral | 1/4 (25%) | 7/25 (28%) | 3/4 (75%) | 4/17 (23.5%) | ||||
| Pain | 1/4 (25%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Pyrexia | 4/4 (100%) | 23/25 (92%) | 4/4 (100%) | 17/17 (100%) | ||||
| Hepatobiliary disorders | ||||||||
| Bile duct stenosis | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Hepatic failure | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Hepatic pain | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Hepatomegaly | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Jaundice | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Immune system disorders | ||||||||
| Cytokine release syndrome | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 0/17 (0%) | ||||
| Drug hypersensitivity | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Infections and infestations | ||||||||
| Biliary tract infection | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Candida infection | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Clostridium difficile colitis | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Folliculitis | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Gingivitis | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Lip infection | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Oral herpes | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 3/17 (17.6%) | ||||
| Pelvic infection | 0/4 (0%) | 0/25 (0%) | 1/4 (25%) | 0/17 (0%) | ||||
| Rash pustular | 3/4 (75%) | 11/25 (44%) | 1/4 (25%) | 6/17 (35.3%) | ||||
| Sepsis | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Skin infection | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 0/17 (0%) | ||||
| Urinary tract infection | 1/4 (25%) | 1/25 (4%) | 0/4 (0%) | 2/17 (11.8%) | ||||
| Urinary tract infection bacterial | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Arthropod bite | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Fall | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Procedural pain | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Splinter | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Investigations | ||||||||
| Activated partial thromboplastin time prolonged | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Alanine aminotransferase increased | 0/4 (0%) | 3/25 (12%) | 0/4 (0%) | 0/17 (0%) | ||||
| Aspartate aminotransferase increased | 1/4 (25%) | 3/25 (12%) | 0/4 (0%) | 0/17 (0%) | ||||
| Blood albumin decreased | 0/4 (0%) | 3/25 (12%) | 0/4 (0%) | 0/17 (0%) | ||||
| Blood alkaline phosphatase increased | 0/4 (0%) | 4/25 (16%) | 0/4 (0%) | 0/17 (0%) | ||||
| Blood bilirubin increased | 2/4 (50%) | 8/25 (32%) | 1/4 (25%) | 1/17 (5.9%) | ||||
| Blood creatinine increased | 0/4 (0%) | 0/25 (0%) | 1/4 (25%) | 0/17 (0%) | ||||
| Blood lactate dehydrogenase increased | 1/4 (25%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Blood potassium decreased | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Gamma-glutamyltransferase increased | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Haematocrit decreased | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Haemoglobin decreased | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| International normalised ratio increased | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Lymphocyte count decreased | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Neutrophil count decreased | 0/4 (0%) | 0/25 (0%) | 3/4 (75%) | 1/17 (5.9%) | ||||
| Platelet count decreased | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 2/17 (11.8%) | ||||
| Red blood cell count decreased | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Troponin increased | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Weight decreased | 1/4 (25%) | 3/25 (12%) | 0/4 (0%) | 2/17 (11.8%) | ||||
| Weight increased | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| White blood cell count decreased | 0/4 (0%) | 0/25 (0%) | 1/4 (25%) | 2/17 (11.8%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 2/4 (50%) | 4/25 (16%) | 4/4 (100%) | 7/17 (41.2%) | ||||
| Dehydration | 1/4 (25%) | 1/25 (4%) | 1/4 (25%) | 4/17 (23.5%) | ||||
| Hypoalbuminaemia | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Hypocalcaemia | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Hypoglycaemia | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Hypokalaemia | 1/4 (25%) | 2/25 (8%) | 1/4 (25%) | 4/17 (23.5%) | ||||
| Hypomagnesaemia | 0/4 (0%) | 0/25 (0%) | 1/4 (25%) | 0/17 (0%) | ||||
| Hyponatraemia | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 3/17 (17.6%) | ||||
| Back pain | 1/4 (25%) | 2/25 (8%) | 0/4 (0%) | 5/17 (29.4%) | ||||
| Bone pain | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Flank pain | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Joint range of motion decreased | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Muscle spasms | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Muscular weakness | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 2/17 (11.8%) | ||||
| Musculoskeletal chest pain | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Musculoskeletal pain | 0/4 (0%) | 1/25 (4%) | 1/4 (25%) | 3/17 (17.6%) | ||||
| Myalgia | 1/4 (25%) | 5/25 (20%) | 1/4 (25%) | 3/17 (17.6%) | ||||
| Neck pain | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Pain in extremity | 0/4 (0%) | 1/25 (4%) | 1/4 (25%) | 0/17 (0%) | ||||
| Pain in jaw | 0/4 (0%) | 0/25 (0%) | 1/4 (25%) | 0/17 (0%) | ||||
| Spinal pain | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Cancer pain | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 2/17 (11.8%) | ||||
| Metastases to bone | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Metastases to central nervous system | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Metastatic pain | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Nervous system disorders | ||||||||
| Burning sensation | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Dizziness | 2/4 (50%) | 1/25 (4%) | 1/4 (25%) | 2/17 (11.8%) | ||||
| Dysaesthesia | 0/4 (0%) | 0/25 (0%) | 2/4 (50%) | 0/17 (0%) | ||||
| Dysgeusia | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Encephalopathy | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Extensor plantar response | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Headache | 1/4 (25%) | 12/25 (48%) | 3/4 (75%) | 7/17 (41.2%) | ||||
| Paraesthesia | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Peripheral sensory neuropathy | 0/4 (0%) | 0/25 (0%) | 1/4 (25%) | 3/17 (17.6%) | ||||
| Somnolence | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Psychiatric disorders | ||||||||
| Anxiety | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Confusional state | 1/4 (25%) | 1/25 (4%) | 0/4 (0%) | 2/17 (11.8%) | ||||
| Depression | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Encopresis | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Hallucination | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Insomnia | 1/4 (25%) | 2/25 (8%) | 1/4 (25%) | 2/17 (11.8%) | ||||
| Renal and urinary disorders | ||||||||
| Acute kidney injury | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Chromaturia | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Pollakiuria | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Stress urinary incontinence | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Urge incontinence | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Urinary retention | 2/4 (50%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Urinary tract pain | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Urine flow decreased | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Oedema genital | 0/4 (0%) | 0/25 (0%) | 1/4 (25%) | 0/17 (0%) | ||||
| Pelvic pain | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 0/4 (0%) | 3/25 (12%) | 1/4 (25%) | 1/17 (5.9%) | ||||
| Dysphonia | 0/4 (0%) | 0/25 (0%) | 1/4 (25%) | 1/17 (5.9%) | ||||
| Dyspnoea | 0/4 (0%) | 6/25 (24%) | 2/4 (50%) | 2/17 (11.8%) | ||||
| Haemoptysis | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Hypoxia | 1/4 (25%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Nasal congestion | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
| Oropharyngeal pain | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Pleural effusion | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 0/17 (0%) | ||||
| Pleuritic pain | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Respiratory distress | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Tachypnoea | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Wheezing | 0/4 (0%) | 2/25 (8%) | 2/4 (50%) | 0/17 (0%) | ||||
| Rash maculo-papular | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 0/17 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Alopecia | 0/4 (0%) | 0/25 (0%) | 2/4 (50%) | 6/17 (35.3%) | ||||
| Blister | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Capillaritis | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Dermatitis bullous | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Hyperhidrosis | 0/4 (0%) | 1/25 (4%) | 1/4 (25%) | 1/17 (5.9%) | ||||
| Pruritus | 0/4 (0%) | 3/25 (12%) | 1/4 (25%) | 0/17 (0%) | ||||
| Rash | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Skin lesion | 0/4 (0%) | 2/25 (8%) | 0/4 (0%) | 2/17 (11.8%) | ||||
| Urticaria | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Vascular disorders | ||||||||
| Aortic stenosis | 0/4 (0%) | 0/25 (0%) | 0/4 (0%) | 1/17 (5.9%) | ||||
| Flushing | 0/4 (0%) | 1/25 (4%) | 1/4 (25%) | 0/17 (0%) | ||||
| Hot flush | 0/4 (0%) | 1/25 (4%) | 0/4 (0%) | 0/17 (0%) | ||||
| Hypertension | 0/4 (0%) | 5/25 (20%) | 2/4 (50%) | 7/17 (41.2%) | ||||
| Hypotension | 2/4 (50%) | 16/25 (64%) | 3/4 (75%) | 11/17 (64.7%) | ||||
| Phlebitis | 1/4 (25%) | 0/25 (0%) | 0/4 (0%) | 0/17 (0%) | ||||
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 | Kyoung Soo Ha, Head of Clinical Development |
|---|---|
| Organization | Sillajen Biotherapeutics Inc. |
| Phone | +1-415-281-8886 |
| ksha@kr.sillajen.com |
Responsible Party:
Jennerex Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01394939
Other Study ID Numbers:
- JX594-CRC019
First Posted:
Jul 15, 2011
Last Update Posted:
Jan 8, 2021
Last Verified:
Dec 1, 2020