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:
BioMed Valley Discoveries, Inc
Information provided by (Responsible Party):
BioMed Valley Discoveries, Inc
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Participant Flow
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 |
---|---|---|---|---|---|---|
![]() |
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 |
Baseline Characteristics
Arm/Group Title | Cohort 1 | Cohort 2 | Cohort 3 | Cohort 4 | Cohort 5 | Cohort 6 | Total | |
---|---|---|---|---|---|---|---|---|
![]() |
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 | |
![]() |
[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%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
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
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):
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 |