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Safety Study of Intratumoral Injection of Clostridium Novyi-NT Spores to Treat Patients With Solid Tumors That Have Not Responded to Standard Therapies

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: NCT01924689
Recruitment Status : Completed
First Posted : August 16, 2013
Results First Posted : September 9, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Solid Tumor Malignancies
Intervention Biological: Clostridium novyi-NT spores
Enrollment 24
Recruitment Details This study was conducted at 7 study centers in the United States. A total of 24 patients were enrolled at 4 study centers. Three study centers did not enroll patients.
Pre-assignment Details Patients who provided informed consent underwent screening procedures within the 21 days preceding C. novyi-NT (Clostridium novyi-Non-Toxic) spore administration. Patients reported to the clinical site 24 hours prior to study Day 0 to reconfirm eligibility and for baseline assessments. Assessments were done as per the schedule of assessment.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description Patients received only single dose of C. novyi-NT spores (Cohort 1: 1 x 10^4 spores) as an intratumoral (IT) injection, per protocol (pp). Patients received only single dose of C. novyi-NT spores (Cohort 2: 3 x 10^4 spores) as an IT injection, pp. Patients received only single dose of C. novyi-NT spores (Cohort 3: 10 x 10^4 spores) as an IT injection, pp. Patients received only single dose of C. novyi-NT spores (Cohort 4: 30 x 10^4 spores) as an IT injection, pp. Patients received only single dose of C. novyi-NT spores (Cohort 5: 100 x 10^4 spores) as an IT injection, pp. Patients received only single dose of C. novyi-NT spores (Cohort 6: 300 x 10^4 spores) as an IT injection, pp.
Period Title: Overall Study
Started 3 3 4 6 6 2
Completed 0 0 0 0 0 0
Not Completed 3 3 4 6 6 2
Reason Not Completed
Death             0             1             0             1             0             0
Disease progression             0             0             2             0             3             2
New therapy or study             3             2             1             4             2             0
Withdrawal of consent             0             0             1             1             0             0
Other             0             0             0             0             1             0
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6 Total
Hide Arm/Group Description Cohort 1: 1 x 10^4 spores Cohort 2: 3 x 10^4 spores Cohort 3: 10 x 10^4 spores Cohort 4: 30 x 10^4 spores Cohort 5: 100 x 10^4 spores Cohort 6: 300 x 10^4 spores Total of all reporting groups
Overall Number of Baseline Participants 3 3 4 6 6 2 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 3 participants 4 participants 6 participants 6 participants 2 participants 24 participants
52.7  (14.50) 55.3  (8.08) 48.3  (14.13) 57.2  (12.72) 59.2  (9.85) 65.0  (0) 56.0  (11.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 6 participants 6 participants 2 participants 24 participants
Female
2
  66.7%
2
  66.7%
3
  75.0%
3
  50.0%
2
  33.3%
0
   0.0%
12
  50.0%
Male
1
  33.3%
1
  33.3%
1
  25.0%
3
  50.0%
4
  66.7%
2
 100.0%
12
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 6 participants 6 participants 2 participants 24 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  16.7%
0
   0.0%
1
   4.2%
Not Hispanic or Latino
2
  66.7%
3
 100.0%
4
 100.0%
6
 100.0%
5
  83.3%
2
 100.0%
22
  91.7%
Unknown or Not Reported
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 4 participants 6 participants 6 participants 2 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
  33.3%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   8.3%
White
2
  66.7%
2
  66.7%
4
 100.0%
6
 100.0%
6
 100.0%
2
 100.0%
22
  91.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Number of Patients With Treatment-emergent Adverse Events (TEAE)
Hide Description

To determine the safety profile of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when administered as a single IT injection.

CTCAE: Common Terminology Criteria for Adverse Events
Time Frame From screening until follow-up visit (up to 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety data set included all patients who received any amount of C. novyi-NT, the investigational medicinal product (IMP). Patients were included in the safety analysis according to the dose of IMP received.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Cohort 1: 1 x 10^4 spores
Cohort 2: 3 x 10^4 spores
Cohort 3: 10 x 10^4 spores
Cohort 4: 30 x 10^4 spores
Cohort 5: 100 x 10^4 spores
Cohort 6: 300 x 10^4 spores
Overall Number of Participants Analyzed 3 3 4 6 6 2
Measure Type: Number
Unit of Measure: Patients
All TEAEs 3 3 4 6 6 2
Related TEAEs 2 3 2 4 3 2
CTCAE Grade 1 TEAEs 3 3 4 5 6 2
CTCAE Grade 2 TEAEs 1 3 4 3 2 2
CTCAE Grade 3 TEAEs 1 3 2 3 3 2
Life-Threatening TEAEs 0 1 0 1 0 2
Deaths 0 1 0 1 0 0
Serious TEAEs 1 2 1 4 3 2
2.Primary Outcome
Title Number of Patients With Adverse Events Qualified as Dose Limiting Toxicities (DLTs)
Hide Description To determine the DLTs of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when administered as a single IT injection.
Time Frame From screening until follow-up visit (up to 12 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The safety data set included all patients who received any amount of C. novyi-NT, IMP. Patients were included in the safety analysis according to the dose of IMP received.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Cohort 1: 1 x 10^4 spores
Cohort 2: 3 x 10^4 spores
Cohort 3: 10 x 10^4 spores
Cohort 4: 30 x 10^4 spores
Cohort 5: 100 x 10^4 spores
Cohort 6: 300 x 10^4 spores
Overall Number of Participants Analyzed 3 3 4 6 6 2
Measure Type: Number
Unit of Measure: Patients
Patient with any AEs qualified as DLTs 0 0 0 1 0 2
Patient with Gas gangrene qualified as DLTs 0 0 0 0 0 1
Patient with Sepsis qualified as DLTs 0 0 0 1 0 1
3.Secondary Outcome
Title Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans
Hide Description

To document preliminary anti-tumor activity of the injected lesion after administering a single IT injection of C. novyi-NT in humans with treatment-refractory solid tumor malignancies. Response and progression was evaluated using the international criteria proposed by the RECIST 1.1. Objective responses were measured by serial CT or MRI scans of the injected lesion and sites of metastatic involvement. Overall response, based on CT/MRI scan results, was based on observation of measurable and non-measurable disease as compared to baseline and nadir in target and non-target tumors per RECIST 1.1.

Change from baseline is presented.
Time Frame At screening, at follow up (at 1, 2, 4, and 8 months (±2 days) after dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Cohort 1: 1 x 10^4 spores
Cohort 2: 3 x 10^4 spores
Cohort 3: 10 x 10^4 spores
Cohort 4: 30 x 10^4 spores
Cohort 5: 100 x 10^4 spores
Cohort 6: 300 x 10^4 spores
Overall Number of Participants Analyzed 3 3 4 6 6 2
Measure Type: Number
Unit of Measure: Percentage of change
Patient 1, Month 1 Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants
1.32
Patient 1, Month 2 Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants
-23.68
Patient 2, Month 1 and Month 2 Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants
0
Patient 3, Month 1 Number Analyzed 1 participants 0 participants 0 participants 0 participants 0 participants 0 participants
19.23
Patient 4, Month 1 Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
-21.90
Patient 4, Month 2 Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
0
Patient 5, Month 1 Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
11.54
Patient 6, Month 1 Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
10.71
Patient 6, Month 2 Number Analyzed 0 participants 1 participants 0 participants 0 participants 0 participants 0 participants
32.14
Patient 7, Month 1 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
NA [1] 
Patient 8, Month 1 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
-20
Patient 9, Month 1 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
-1.85
Patient 10, Month 1 Number Analyzed 0 participants 0 participants 1 participants 0 participants 0 participants 0 participants
6.67
Patient 11, Month 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
-2.22
Patient 11, Month 2 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
15.56
Patient 12, Month 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
13.56
Patient 12, Month 2 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
1.69
Patient 12, Month 4 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
-13.56
Patient 12, Month 8 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
13.56
Patient 13, Month 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
26.61
Patient 13, Month 2 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
42.20
Patient 14, Month 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
14.29
Patient 14, Month 2 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
14.29
Patient 15, Month 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
16.95
Patient 16, Month 1 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
-11.76
Patient 16, Month 2 Number Analyzed 0 participants 0 participants 0 participants 1 participants 0 participants 0 participants
-14.29
Patient 17, Month 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
-7.14
Patient 17, Month 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
0
Patient 17, Month 4 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
3.57
Patient 17, Month 8 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
10.71
Patient 18, Month 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
30.23
Patient 18, Month 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
86.05
Patient 19, Month 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
-6.67
Patient 19, Month 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
6.67
Patient 20, Month 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
48.24
Patient 20, Month 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
23.53
Patient 21, Month 1, Month 2, Month 4 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
NA [1] 
Patient 22, Month 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
12.20
Patient 22, Month 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
19.51
Patient 23, Month 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
3.13
Patient 23, Month 2 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
18.75
Patient 24, Month 1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 1 participants 0 participants
19.30
[1]
This patient did not have tumor assessments performed at Month 1
4.Secondary Outcome
Title Number of Patients With RECIST Assessment on the Injected Lesion
Hide Description

To document preliminary anti-tumor activity of the injected lesion after administering a single IT injection of C. novyi-NT in humans with treatment-refractory solid tumor malignancies. The evaluation of anti-tumor activity included a response for the injected lesion.

Response and progression was evaluated using the international criteria proposed by the RECIST 1.1. Objective responses were measured by serial CT or MRI scans of the injected lesion and sites of metastatic involvement. Overall response, based on CT/MRI scan results, was based on observation of measurable and non-measurable disease as compared to baseline and nadir in target and non-target tumors per RECIST 1.1.
Time Frame At follow up (at 1 and 2, 4, and 8 months (±2 days) after dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Cohort 1: 1 x 10^4 spores
Cohort 2: 3 x 10^4 spores
Cohort 3: 10 x 10^4 spores
Cohort 4: 30 x 10^4 spores
Cohort 5: 100 x 10^4 spores
Cohort 6: 300 x 10^4 spores
Overall Number of Participants Analyzed 3 3 4 6 6 2
Measure Type: Number
Unit of Measure: Patients
Month 1, Complete Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 1, Partial Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 1, Stable Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
3 3 3 6 6 0
Month 1, Progressive Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 1
Month 1, Unknown Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 2, Complete Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 2, Partial Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 2, Stable Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
2 0 0 4 3 0
Month 2, Progressive Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 2 0 1 2 1
Month 2, Unknown Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 4, Complete Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 4, Partial Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 4, Stable Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 1 1 0
Month 4, Progressive Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 4, Unknown Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 8, Complete Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 8, Partial Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 8, Stable Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 8, Progressive Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 1 1 0
Month 8, Unknown Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
5.Secondary Outcome
Title Number of Patients With Overall RECIST Response
Hide Description To document preliminary anti-tumor activity of an overall response after administering a single IT injection of C. novyi-NT in humans with treatment-refractory solid tumor malignancies. The evaluation of anti-tumor activity included an overall response.
Time Frame At follow up (at 1 and 2, 4, and 8 months (±2 days) after dosing)
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Cohort 1: 1 x 10^4 spores
Cohort 2: 3 x 10^4 spores
Cohort 3: 10 x 10^4 spores
Cohort 4: 30 x 10^4 spores
Cohort 5: 100 x 10^4 spores
Cohort 6: 300 x 10^4 spores
Overall Number of Participants Analyzed 3 3 4 6 6 2
Measure Type: Number
Unit of Measure: Patients
Month 1, Complete Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 1, Partial Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 1, Stable Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
2 2 3 6 6 0
Month 1, Progressive Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
1 1 0 0 0 0
Month 1, Unknown Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 1
Month 2, Complete Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 2, Partial Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 2, Stable Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
2 0 0 4 3 0
Month 2, Progressive Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 2 0 1 2 1
Month 2, Unknown Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 4, Complete Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 4, Partial Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 4, Stable Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 1 1 0
Month 4, Progressive Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 4, Unknown Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 8, Complete Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 8, Partial Response Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 8, Stable Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
Month 8, Progressive Disease Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 1 1 0
Month 8, Unknown Number Analyzed 3 participants 3 participants 3 participants 6 participants 6 participants 1 participants
0 0 0 0 0 0
6.Secondary Outcome
Title Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT
Hide Description To study the presence of circulating C. novyi-NT spores after administration as a single IT injection to humans with treatment-refractory solid tumor malignancies.
Time Frame At Screening, at Days -1 to 0, at Days 1, 2, 3, 4, 5, 7, at follow up (at 2 months (±2 days) after dosing)
Hide Outcome Measure Data
Hide Analysis Population Description

The safety data set included all patients who received any amount of C. novyi-NT, the IMP. Patients were included in the safety analysis according to the dose of IMP received.

Note: Two patients had positive C.novyi culture at Screening due to contamination, and one patient in Cohort 4 had positive C. novyi culture on Day 3 due to contamination.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Cohort 1: 1 x 10^4 spores
Cohort 2: 3 x 10^4 spores
Cohort 3: 10 x 10^4 spores
Cohort 4: 30 x 10^4 spores
Cohort 5: 100 x 10^4 spores
Cohort 6: 300 x 10^4 spores
Overall Number of Participants Analyzed 3 3 4 6 6 2
Measure Type: Number
Unit of Measure: Patients
Scheduled, Screening 0 1 0 0 0 1
Scheduled, Day -1 to Day 0 0 0 0 0 1 0
Scheduled, Day 1 0 0 0 0 1 1
Scheduled, Day 2 0 0 0 1 0 0
Scheduled, Day 3 1 0 0 1 0 0
Scheduled, Day 4 1 0 0 0 0 0
Scheduled, Day 5 1 0 0 0 0 0
Scheduled, Day 7 0 0 0 0 0 1
Scheduled, Month 2 1 0 0 0 0 0
7.Secondary Outcome
Title Number of Patients With Cytokine Responses Analyzed
Hide Description

The host immune and inflammatory response to C. novyi-NT spores was measured in routine blood sampling over the course of the study.

The following table presents the data for the patients who had analyzable cytokine data.

This table was included to simply indicate the number of patients who participated in the cytokine response analysis.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Cohort 1: 1 x 10^4 spores
Cohort 2: 3 x 10^4 spores
Cohort 3: 10 x 10^4 spores
Cohort 4: 30 x 10^4 spores
Cohort 5: 100 x 10^4 spores
Cohort 6: 300 x 10^4 spores
Overall Number of Participants Analyzed 3 3 4 6 6 2
Measure Type: Number
Unit of Measure: Patients
3 3 4 6 6 2
8.Secondary Outcome
Title Number of Patients With Systemic Tumor Antigen Specific T-cell Responses
Hide Description

The host immune and inflammatory response to C. novyi-NT spores was measured in routine blood sampling over the course of the study. Release of T-cell cytokines and effector molecules (interferon [IFN]-γ , Granzyme B, and tumor necrosis factor [TNF]-α) from the patient's own peripheral blood mononuclear cells (PBMCs) treated with allogenic tumor cell line lysates were quantified by Enzyme-Linked Immunosorbent Spot (ELISPOT) assays. A positive response was defined as a frequency that is significantly (p <0.05, two-tailed t-test) greater than the mean of control no-antigen wells and detectable (i.e., >1:100,000).

No patients were analyzed for Cohort 1 and Cohort 2 based on the original study protocol.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.
Arm/Group Title Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Cohort 3: 10 x 10^4 spores
Cohort 4: 30 x 10^4 spores
Cohort 5: 100 x 10^4 spores
Cohort 6: 300 x 10^4 spores
Overall Number of Participants Analyzed 3 4 4 1
Measure Type: Number
Unit of Measure: Patients
1 2 3 1
9.Secondary Outcome
Title Number of Patients With Local Tumor-specific T-cell Responses
Hide Description

The host immune and inflammatory response to C. novyi-NT spores was measured in routine blood sampling over the course of the study. Immunostaining for tumor infiltrating cells was analyzed independently by 2 investigators. Respective counting of 3 slides per patient between 5 to 20 fields of vision at 200x were scored using the modified ALLRED scoring method. Respective counts were averaged in each case. Pre and post treatment needle biopsies from injected and non-injected tumors were stained for the presence of tumor infiltrating immune cells.

No patients were analyzed for Cohort 1 and Cohort 2 based on the original study protocol.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
The efficacy data set or full analysis set consisted of all patients in the safety population who had both a baseline tumor assessment and at least one post-baseline tumor assessment. Patients were included in the analysis according to the dose of IMP received.
Arm/Group Title Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description:
Cohort 3: 10 x 10^4 spores
Cohort 4: 30 x 10^4 spores
Cohort 5: 100 x 10^4 spores
Cohort 6: 300 x 10^4 spores
Overall Number of Participants Analyzed 1 3 3 2
Measure Type: Number
Unit of Measure: Patients
0 1 0 2
Time Frame From screening until follow-up visit (up to 12 months)
Adverse Event Reporting Description An Adverse Event (AE) was any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation subject administered an investigational medicinal product, even if it did not have a causal relationship with that product. Any unfavorable or unintended sign, symptom, or disease temporally associated with the use of the study agent, whether or not it was considered study agent-related was considered an AE.
 
Arm/Group Title Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Hide Arm/Group Description Cohort 1: 1 x 10^4 spores Cohort 2: 3 x 10^4 spores Cohort 3: 10 x 10^4 spores Cohort 4: 30 x 10^4 spores Cohort 5: 100 x 10^4 spores Cohort 6: 300 x 10^4 spores
All-Cause Mortality
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   1/3 (33.33%)   0/4 (0.00%)   1/6 (16.67%)   0/6 (0.00%)   0/2 (0.00%) 
Hide Serious Adverse Events
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)   2/3 (66.67%)   1/4 (25.00%)   4/6 (66.67%)   3/6 (50.00%)   2/2 (100.00%) 
Gastrointestinal disorders             
Disease progression * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/2 (0.00%) 
Oedema peripheral * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Infections and infestations             
Abdominal abscess * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Abscess limb * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Gas gangrene * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Sepsis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/2 (50.00%) 
Soft tissue infection * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Metabolism and nutrition disorders             
Dehydration * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders             
Pathological fracture * 1  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Tumour haemorrhage * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Nervous system disorders             
Cerebral haemorrhage * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Phantom pain * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Reproductive system and breast disorders             
Genital swelling * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Pleural effusion * 1  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Surgical and medical procedures             
Limb salvage therapy * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Osteosynthesis * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
1
Term from vocabulary, MedDRA (14.1)
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort 1 Cohort 2 Cohort 3 Cohort 4 Cohort 5 Cohort 6
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/3 (100.00%)   4/4 (100.00%)   6/6 (100.00%)   6/6 (100.00%)   2/2 (100.00%) 
Blood and lymphatic system disorders             
Anaemia * 1  1/3 (33.33%)  3/3 (100.00%)  3/4 (75.00%)  2/6 (33.33%)  2/6 (33.33%)  2/2 (100.00%) 
Cardiac disorders             
Tachycardia * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/2 (50.00%) 
Gastrointestinal disorders             
Constipation * 1  0/3 (0.00%)  0/3 (0.00%)  4/4 (100.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Diarrhoea * 1  0/3 (0.00%)  2/3 (66.67%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Nausea * 1  0/3 (0.00%)  2/3 (66.67%)  4/4 (100.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Vomiting * 1  0/3 (0.00%)  1/3 (33.33%)  3/4 (75.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
General disorders             
Fatigue * 1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Injection site pain * 1  0/3 (0.00%)  1/3 (33.33%)  2/4 (50.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Oedema peripheral * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Pyrexia * 1  1/3 (33.33%)  2/3 (66.67%)  1/4 (25.00%)  3/6 (50.00%)  3/6 (50.00%)  1/2 (50.00%) 
Infections and infestations             
Cellulitis * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/2 (50.00%) 
Oral candidiasis * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Investigations             
Blood alkaline phosphatase increased * 1  0/3 (0.00%)  0/3 (0.00%)  2/4 (50.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Blood creatinine increased * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/2 (0.00%) 
Lymphocyte count decreased * 1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
White blood cell count decreased * 1  0/3 (0.00%)  0/3 (0.00%)  2/4 (50.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Metabolism and nutrition disorders             
Decreased appetite * 1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Hyperglycaemia * 1  0/3 (0.00%)  0/3 (0.00%)  2/4 (50.00%)  0/6 (0.00%)  1/6 (16.67%)  0/2 (0.00%) 
Hypoalbuminaemia * 1  0/3 (0.00%)  0/3 (0.00%)  2/4 (50.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Hypocalcaemia * 1  0/3 (0.00%)  0/3 (0.00%)  2/4 (50.00%)  1/6 (16.67%)  1/6 (16.67%)  0/2 (0.00%) 
Hypokalaemia * 1  1/3 (33.33%)  0/3 (0.00%)  2/4 (50.00%)  1/6 (16.67%)  0/6 (0.00%)  0/2 (0.00%) 
Hyponatraemia * 1  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/2 (50.00%) 
Hypophosphataemia * 1  0/3 (0.00%)  2/3 (66.67%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/2 (50.00%) 
Musculoskeletal and connective tissue disorders             
Musculoskeletal pain * 1  1/3 (33.33%)  1/3 (33.33%)  0/4 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Psychiatric disorders             
Anxiety * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/2 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Cough * 1  1/3 (33.33%)  1/3 (33.33%)  2/4 (50.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Dyspnoea * 1  1/3 (33.33%)  1/3 (33.33%)  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  1/2 (50.00%) 
Skin and subcutaneous tissue disorders             
Pruritus * 1  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  0/6 (0.00%)  0/6 (0.00%)  0/2 (0.00%) 
Vascular disorders             
Hypertension * 1  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  1/2 (50.00%) 
Hypotension * 1  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%)  2/6 (33.33%)  0/6 (0.00%)  1/2 (50.00%) 
1
Term from vocabulary, MedDRA (14.1)
*
Indicates events were collected by non-systematic assessment
[Not Specified]
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.
This document contains confidential information of BioMed Valley Discoveries, Inc. Do not copy or distribute without written permission from the Sponsor.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Brent Kreider
Organization: BioMed Valley Discoveries, Inc.
Phone: 816-960-4644
EMail: bkreider@biomed-valley.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: BioMed Valley Discoveries, Inc
ClinicalTrials.gov Identifier: NCT01924689    
Other Study ID Numbers: BVDCNV2
First Submitted: August 14, 2013
First Posted: August 16, 2013
Results First Submitted: January 23, 2019
Results First Posted: September 9, 2019
Last Update Posted: September 9, 2019