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Safety and Efficacy of Listeria in Combination With Chemotherapy as Front-line Treatment for Malignant Pleural Mesothelioma

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: NCT01675765
Recruitment Status : Completed
First Posted : August 30, 2012
Results First Posted : September 30, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
Aduro Biotech, Inc.

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Malignant Pleural Mesothelioma
Interventions Biological: Immunotherapy plus chemotherapy
Biological: Immunotherapy with cyclophosphamide plus chemotherapy
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Immunotherapy Plus Chemotherapy Immunotherapy With Cyclophosphamide Plus Chemotherapy
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Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: CRS-207

Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy plus chemotherapy: live attenuated double deleted Lm

Weeks 1 and 3: cyclophosphamide (200 mg/m^2), CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: cyclophosphamide one day before CRS-207

Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm

Period Title: Overall Study
Started 38 22
Completed 27 14
Not Completed 11 8
Reason Not Completed
Progressive disease             4             4
Adverse Event             1             2
Withdrawal by Subject             2             0
Death             1             0
Clinical progression             3             2
Arm/Group Title Immunotherapy Plus Chemotherapy Immunotherapy With Cyclophosphamide Plus Chemotherapy Total
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Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: CRS-207

Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy plus chemotherapy: live attenuated double deleted Lm

Weeks 1 and 3: cyclophosphamide (200 mg/m^2), CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: cyclophosphamide one day before CRS-207

Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm

Total of all reporting groups
Overall Number of Baseline Participants 38 22 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 22 participants 60 participants
<65 years
9
  23.7%
6
  27.3%
15
  25.0%
>=65 years
29
  76.3%
16
  72.7%
45
  75.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 22 participants 60 participants
Female
4
  10.5%
5
  22.7%
9
  15.0%
Male
34
  89.5%
17
  77.3%
51
  85.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 22 participants 60 participants
Hispanic or Latino
1
   2.6%
0
   0.0%
1
   1.7%
Not Hispanic or Latino
37
  97.4%
22
 100.0%
59
  98.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 22 participants 60 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   5.3%
0
   0.0%
2
   3.3%
White
36
  94.7%
22
 100.0%
58
  96.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 38 participants 22 participants 60 participants
81.63  (16.203) 73.83  (12.340) 78.77  (15.271)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 38 participants 22 participants 60 participants
174.51  (8.295) 168.41  (7.102) 172.28  (8.359)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 38 participants 22 participants 60 participants
26.702  (4.3292) 26.076  (4.4584) 26.473  (4.3498)
Body Surface Area  
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 38 participants 22 participants 60 participants
1.982  (0.2230) 1.852  (0.1756) 1.935  (0.2148)
1.Primary Outcome
Title Number of Subjects Reporting Adverse Events
Hide Description Count of subjects with incidences of adverse events.
Time Frame From first study dose until 28 days after the final dose (an average of 44 weeks)
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Hide Analysis Population Description
Safety Analysis Set (all participants who received >= 1 dose of study treatment)
Arm/Group Title Immunotherapy Plus Chemotherapy Immunotherapy With Cyclophosphamide Plus Chemotherapy
Hide Arm/Group Description:

Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: CRS-207

Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy plus chemotherapy: live attenuated double deleted Lm

Weeks 1 and 3: cyclophosphamide (200 mg/m^2), CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: cyclophosphamide one day before CRS-207

Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm

Overall Number of Participants Analyzed 38 22
Measure Type: Count of Participants
Unit of Measure: Participants
38
 100.0%
22
 100.0%
2.Primary Outcome
Title Induction of Immune Response to Mesothelin by Enzyme-linked Immunosorbent Spot (ELISPOT) Assay
Hide Description [Not Specified]
Time Frame Change over time assessed at multiple time points until disease progression or death (up to 12 months or longer)
Hide Outcome Measure Data
Hide Analysis Population Description
Immune response to mesothelin was not assessed.
Arm/Group Title Immunotherapy Plus Chemotherapy Immunotherapy With Cyclophosphamide Plus Chemotherapy
Hide Arm/Group Description:

Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: CRS-207

Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy plus chemotherapy: live attenuated double deleted Lm

Weeks 1 and 3: cyclophosphamide (200 mg/m^2), CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: cyclophosphamide one day before CRS-207

Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Objective Tumor Response
Hide Description Objective tumor response was measured using modified Response Evaluation Criteria in Solid Tumors (mRECIST) for assessment of response in malignant pleural mesothelioma (MPM). Per mRECIST for target lesions and assessed by CT: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease, those who fulfilled the criteria for neither PR nor PD; Progressive Disease (PD), >=20% increase in the sum of the longest diameter of target lesions.
Time Frame Baseline to measured disease progression or death (up to 12 months or longer)
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Hide Analysis Population Description
Safety analysis set: all enrolled subjects who received at least one dose of study treatment and had measurable disease.
Arm/Group Title Immunotherapy Plus Chemotherapy Immunotherapy With Cyclophosphamide Plus Chemotherapy
Hide Arm/Group Description:

Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: CRS-207

Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy plus chemotherapy: live attenuated double deleted Lm

Weeks 1 and 3: cyclophosphamide (200 mg/m^2), CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: cyclophosphamide one day before CRS-207

Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm

Overall Number of Participants Analyzed 36 21
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response
1
   2.8%
0
   0.0%
Partial Response
19
  52.8%
11
  52.4%
Stable Disease
14
  38.9%
8
  38.1%
Progressive Disease
1
   2.8%
2
   9.5%
Not Assessable
1
   2.8%
0
   0.0%
4.Secondary Outcome
Title Time to Progression
Hide Description [Not Specified]
Time Frame From date of randomization until date of documented progression (by modified RECIST or immune-related response criteria) or death, assessed up to 12 months or longer
Hide Outcome Measure Data
Hide Analysis Population Description
Time to progression was not assessed.
Arm/Group Title Immunotherapy Plus Chemotherapy Immunotherapy With Cyclophosphamide Plus Chemotherapy
Hide Arm/Group Description:

Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: CRS-207

Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy plus chemotherapy: live attenuated double deleted Lm

Weeks 1 and 3: cyclophosphamide (200 mg/m^2), CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: cyclophosphamide one day before CRS-207

Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Serum Mesothelin as Correlate of Therapeutic Response
Hide Description [Not Specified]
Time Frame Change over time assessed at multiple time points until disease progression or death (up to 12 months or longer)
Hide Outcome Measure Data
Hide Analysis Population Description
Predictive value of serum mesothelin was not assessed.
Arm/Group Title Immunotherapy Plus Chemotherapy Immunotherapy With Cyclophosphamide Plus Chemotherapy
Hide Arm/Group Description:

Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: CRS-207

Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy plus chemotherapy: live attenuated double deleted Lm

Weeks 1 and 3: cyclophosphamide (200 mg/m^2), CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: cyclophosphamide one day before CRS-207

Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From the start of the first study drug administration until 28 days after the last study drug dose, assessed up to 5 years from the date of randomization.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Immunotherapy Plus Chemotherapy Immunotherapy With Cyclophosphamide Plus Chemotherapy
Hide Arm/Group Description

Weeks 1 and 3: CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: CRS-207

Maintenance Vaccinations: CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy plus chemotherapy: live attenuated double deleted Lm

Weeks 1 and 3: cyclophosphamide (200 mg/m^2), CRS-207 (1 × 10^9 CFU)

Weeks 5, 8, 11, 14, 17 and 20 (up to 6 cycles every 21 days): pemetrexed (500 mg/m^2) and cisplatin (75 mg/m^2)

Weeks 23 and 26: cyclophosphamide one day before CRS-207

Maintenance Vaccinations: cyclophosphamide one day before CRS-207 every 8 weeks (starting at Week 34) until disease progression

Immunotherapy with cyclophosphamide plus chemotherapy: live attenuated double deleted Lm

All-Cause Mortality
Immunotherapy Plus Chemotherapy Immunotherapy With Cyclophosphamide Plus Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   3/38 (7.89%)   0/22 (0.00%) 
Hide Serious Adverse Events
Immunotherapy Plus Chemotherapy Immunotherapy With Cyclophosphamide Plus Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   15/38 (39.47%)   11/22 (50.00%) 
Blood and lymphatic system disorders     
Anaemia  1  1/38 (2.63%)  1/22 (4.55%) 
Cardiac disorders     
Atrial fibrillation  1  1/38 (2.63%)  0/22 (0.00%) 
Gastrointestinal disorders     
Constipation  1  2/38 (5.26%)  1/22 (4.55%) 
Nausea  1  2/38 (5.26%)  0/22 (0.00%) 
Vomiting  1  2/38 (5.26%)  0/22 (0.00%) 
Abdominal pain  1  0/38 (0.00%)  1/22 (4.55%) 
Diarrhoea  1  1/38 (2.63%)  0/22 (0.00%) 
Diverticular perforation  1  0/38 (0.00%)  1/22 (4.55%) 
Gastric ulcer haemorrhage  1  1/38 (2.63%)  0/22 (0.00%) 
Large intestine perforation  1  0/38 (0.00%)  1/22 (4.55%) 
Pancreatitis acute  1  1/38 (2.63%)  0/22 (0.00%) 
Small intestinal obstruction  1  1/38 (2.63%)  0/22 (0.00%) 
General disorders     
Chills  1  1/38 (2.63%)  1/22 (4.55%) 
Pyrexia  1  1/38 (2.63%)  1/22 (4.55%) 
Disease progression  1  1/38 (2.63%)  0/22 (0.00%) 
Influenza like illness  1  0/38 (0.00%)  1/22 (4.55%) 
Infections and infestations     
Pneumonia  1  1/38 (2.63%)  2/22 (9.09%) 
Sepsis  1  0/38 (0.00%)  1/22 (4.55%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  1/38 (2.63%)  0/22 (0.00%) 
Musculoskeletal and connective tissue disorders     
Polyarthritis  1  1/38 (2.63%)  0/22 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Spinal cord neoplasm  1  1/38 (2.63%)  0/22 (0.00%) 
Nervous system disorders     
Headache  1  1/38 (2.63%)  0/22 (0.00%) 
Syncope  1  0/38 (0.00%)  1/22 (4.55%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  3/38 (7.89%)  0/22 (0.00%) 
Haemothorax  1  1/38 (2.63%)  0/22 (0.00%) 
Hypoxia  1  0/38 (0.00%)  1/22 (4.55%) 
Pleuritic pain  1  0/38 (0.00%)  1/22 (4.55%) 
Pulmonary embolism  1  1/38 (2.63%)  0/22 (0.00%) 
1
Term from vocabulary, MedDRA (15.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Immunotherapy Plus Chemotherapy Immunotherapy With Cyclophosphamide Plus Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   38/38 (100.00%)   22/22 (100.00%) 
Blood and lymphatic system disorders     
Anaemia  1  15/38 (39.47%)  8/22 (36.36%) 
Neutropenia  1  3/38 (7.89%)  3/22 (13.64%) 
Leukopenia  1  3/38 (7.89%)  0/22 (0.00%) 
Leukocytosis  1  2/38 (5.26%)  0/22 (0.00%) 
Cardiac disorders     
Sinus tachycardia  1  4/38 (10.53%)  1/22 (4.55%) 
Atrial fibrillation  1  1/38 (2.63%)  2/22 (9.09%) 
Tachycardia  1  2/38 (5.26%)  1/22 (4.55%) 
Ear and labyrinth disorders     
Tinnitus  1  5/38 (13.16%)  1/22 (4.55%) 
Vertigo  1  2/38 (5.26%)  0/22 (0.00%) 
Eye disorders     
Lacrimation increased  1  6/38 (15.79%)  1/22 (4.55%) 
Gastrointestinal disorders     
Nausea  1  31/38 (81.58%)  12/22 (54.55%) 
Vomiting  1  25/38 (65.79%)  5/22 (22.73%) 
Constipation  1  15/38 (39.47%)  7/22 (31.82%) 
Diarrhoea  1  8/38 (21.05%)  2/22 (9.09%) 
Abdominal pain  1  4/38 (10.53%)  5/22 (22.73%) 
Dry mouth  1  4/38 (10.53%)  0/22 (0.00%) 
Ascites  1  2/38 (5.26%)  1/22 (4.55%) 
Gastrooesophageal reflux disease  1  2/38 (5.26%)  1/22 (4.55%) 
Abdominal discomfort  1  2/38 (5.26%)  0/22 (0.00%) 
Dyspepsia  1  2/38 (5.26%)  0/22 (0.00%) 
Flatulence  1  0/38 (0.00%)  2/22 (9.09%) 
General disorders     
Chills  1  37/38 (97.37%)  22/22 (100.00%) 
Pyrexia  1  37/38 (97.37%)  21/22 (95.45%) 
Fatigue  1  23/38 (60.53%)  12/22 (54.55%) 
Oedema peripheral  1  7/38 (18.42%)  3/22 (13.64%) 
Non-cardiac chest pain  1  5/38 (13.16%)  0/22 (0.00%) 
Malaise  1  3/38 (7.89%)  0/22 (0.00%) 
Chest pain  1  2/38 (5.26%)  0/22 (0.00%) 
Oedema  1  2/38 (5.26%)  0/22 (0.00%) 
Mucosal inflammation  1  2/38 (5.26%)  0/22 (0.00%) 
Infections and infestations     
Upper respiratory tract infection  1  3/38 (7.89%)  1/22 (4.55%) 
Pneumonia  1  1/38 (2.63%)  2/22 (9.09%) 
Sinusitis  1  2/38 (5.26%)  1/22 (4.55%) 
Urinary tract infection  1  3/38 (7.89%)  0/22 (0.00%) 
Investigations     
Blood creatinine increased  1  6/38 (15.79%)  7/22 (31.82%) 
White blood cell count decreased  1  7/38 (18.42%)  3/22 (13.64%) 
Alanine aminotransferase increased  1  7/38 (18.42%)  1/22 (4.55%) 
Lymphocyte count decreased  1  5/38 (13.16%)  3/22 (13.64%) 
Neutrophil count decreased  1  7/38 (18.42%)  1/22 (4.55%) 
Aspartate aminotransferase increased  1  6/38 (15.79%)  1/22 (4.55%) 
Platelet count decreased  1  5/38 (13.16%)  2/22 (9.09%) 
Weight decreased  1  4/38 (10.53%)  2/22 (9.09%) 
Blood alkaline phosphatase increased  1  1/38 (2.63%)  3/22 (13.64%) 
Haemoglobin decreased  1  2/38 (5.26%)  2/22 (9.09%) 
Blood urea increased  1  3/38 (7.89%)  0/22 (0.00%) 
Weight increased  1  3/38 (7.89%)  0/22 (0.00%) 
Blood albumin decreased  1  2/38 (5.26%)  0/22 (0.00%) 
Haematocrit decreased  1  0/38 (0.00%)  2/22 (9.09%) 
Metabolism and nutrition disorders     
Decreased appetite  1  19/38 (50.00%)  4/22 (18.18%) 
Hyponatraemia  1  8/38 (21.05%)  3/22 (13.64%) 
Hypoalbuminaemia  1  7/38 (18.42%)  3/22 (13.64%) 
Hypomagnesaemia  1  6/38 (15.79%)  4/22 (18.18%) 
Hyperglycaemia  1  7/38 (18.42%)  2/22 (9.09%) 
Hyperkalaemia  1  5/38 (13.16%)  4/22 (18.18%) 
Dehydration  1  5/38 (13.16%)  2/22 (9.09%) 
Hypophosphataemia  1  5/38 (13.16%)  1/22 (4.55%) 
Hypocalcaemia  1  4/38 (10.53%)  1/22 (4.55%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  7/38 (18.42%)  3/22 (13.64%) 
Musculoskeletal chest pain  1  2/38 (5.26%)  2/22 (9.09%) 
Musculoskeletal pain  1  3/38 (7.89%)  1/22 (4.55%) 
Arthralgia  1  3/38 (7.89%)  0/22 (0.00%) 
Muscular weakness  1  2/38 (5.26%)  0/22 (0.00%) 
Myalgia  1  2/38 (5.26%)  0/22 (0.00%) 
Pain in extremity  1  0/38 (0.00%)  2/22 (9.09%) 
Nervous system disorders     
Headache  1  11/38 (28.95%)  6/22 (27.27%) 
Dizziness  1  8/38 (21.05%)  1/22 (4.55%) 
Neuropathy peripheral  1  6/38 (15.79%)  2/22 (9.09%) 
Dysgeusia  1  5/38 (13.16%)  0/22 (0.00%) 
Syncope  1  2/38 (5.26%)  2/22 (9.09%) 
Tremor  1  2/38 (5.26%)  0/22 (0.00%) 
Psychiatric disorders     
Insomnia  1  4/38 (10.53%)  5/22 (22.73%) 
Anxiety  1  1/38 (2.63%)  2/22 (9.09%) 
Depression  1  2/38 (5.26%)  1/22 (4.55%) 
Renal and urinary disorders     
Renal impairment  1  0/38 (0.00%)  2/22 (9.09%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  10/38 (26.32%)  5/22 (22.73%) 
Cough  1  8/38 (21.05%)  0/22 (0.00%) 
Rhinorrhoea  1  6/38 (15.79%)  2/22 (9.09%) 
Hiccups  1  6/38 (15.79%)  1/22 (4.55%) 
Hypoxia  1  1/38 (2.63%)  4/22 (18.18%) 
Dyspnoea exertional  1  3/38 (7.89%)  1/22 (4.55%) 
Pleural effusion  1  4/38 (10.53%)  0/22 (0.00%) 
Dysphonia  1  3/38 (7.89%)  0/22 (0.00%) 
Pulmonary embolism  1  3/38 (7.89%)  0/22 (0.00%) 
Nasal congestion  1  0/38 (0.00%)  2/22 (9.09%) 
Tachypnoea  1  2/38 (5.26%)  0/22 (0.00%) 
Throat irritation  1  2/38 (5.26%)  0/22 (0.00%) 
Skin and subcutaneous tissue disorders     
Rash  1  6/38 (15.79%)  1/22 (4.55%) 
Night sweats  1  5/38 (13.16%)  1/22 (4.55%) 
Rash maculo-papular  1  4/38 (10.53%)  1/22 (4.55%) 
Hyperhidrosis  1  4/38 (10.53%)  0/22 (0.00%) 
Pruritus  1  4/38 (10.53%)  0/22 (0.00%) 
Urticaria  1  3/38 (7.89%)  0/22 (0.00%) 
Vascular disorders     
Hypotension  1  9/38 (23.68%)  4/22 (18.18%) 
Hypertension  1  6/38 (15.79%)  2/22 (9.09%) 
Flushing  1  3/38 (7.89%)  1/22 (4.55%) 
Deep vein thrombosis  1  2/38 (5.26%)  0/22 (0.00%) 
Jugular vein thrombosis  1  2/38 (5.26%)  0/22 (0.00%) 
1
Term from vocabulary, MedDRA (15.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Disclosure restriction - study results first published in a joint multi-center paper unless (a) no multi-center publication, or (b) ≥18 months has passed since completion of the study. Thereafter, Investigator may publish provided that Investigator: (i) provides a copy of the publication to Aduro ≥ 30 days in advance of submission for publication; (ii) deletes Aduro Confidential Information (other than the Study results) and (iii) submission may be delayed up to 90 days to permit IP filings."
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Corporate Communications
Organization: Aduro Biotech, Inc.
Phone: 510-848-4400
EMail: press@aduro.com
Layout table for additonal information
Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT01675765    
Other Study ID Numbers: ADU-CL-02
First Submitted: August 23, 2012
First Posted: August 30, 2012
Results First Submitted: September 2, 2020
Results First Posted: September 30, 2020
Last Update Posted: September 30, 2020