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This protocol will examine the safety of intratumoral administration of Clostridium Novyi-NT spores in patients with treatment-refractory solid tumor malignancies. This investigational study will measure anti-tumor activity of C. novyi-NT administered intratumoral in patients with treatment-refractory solid tumor malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clostridium novyi-NT spores | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clostridium novyi-NT spores | Biological | Phase 1 study: It will be an escalating dose design, with no intracohort escalation. The first cohort dose will begin at 1 x 10(4) spores/kg and will escalate by tripling through 5 cohorts up to 100 x 10(4) spores/kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment-emergent Adverse Events (TEAE) | 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 | From screening until follow-up visit (up to 12 months) |
| Number of Patients With Adverse Events Qualified as Dose Limiting Toxicities (DLTs) | To determine the DLTs of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when administered as a single IT injection. | From screening until follow-up visit (up to 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans | 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. |
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Inclusion Criteria:
Exclusion Criteria:
Positive pregnancy test.
Serum creatinine level > 1.5 x the upper limit of normal (ULN), chronic renal failure requiring hemodialysis or peritoneal dialysis.
Patient has any of the following hematologic parameters:
Oxygen saturation (Sp02) of less than 95% on room air.
Mean arterial blood pressure (BP) of less than 70 mmHg.
Glasgow Coma Score (GCS) of less than 15.
Treatment with an investigational drug within the past 30 days or 5 half-lives of that drug, whichever is shorter.
Documented primary brain malignancy or brain metastases.
Clinically significant ascites or clinical evidence or history of portosystemic hypertension or cirrhosis.
Laboratory evidence of hepatic dysfunction indicated by any of the following:
Patient has a foreign body which in the opinion of the treating investigator could be difficult to manage in case of infection (e.g. prosthetic hip).
Clinically significant pleural effusion.
Clinically significant pericardial effusion, circumferential pericardial effusion, or any effusion greater than 1.0 cm at any location around the heart.
Need for ongoing treatment with an immunosuppressive agent.
History of solid organ transplantation (with the exception of a corneal transplant > 3 months prior to screening).
History of an ischemic insult in the previous 12 months (myocardial infarction, cerebral vascular accident, ischemic tissue from injury, transient ischemic attack.
History of a significant medical illness deemed by the PI or local investigators as unsuitable for the trial. For example:
i. Symptomatic congestive heart failure ii. Psychiatric Illness/social situation that may make study dangerous iii. Unstable angina pectoris
Asplenia.
Antibiotic allergies that would preclude treatment for a C. novyi-NT infection.
Treatment with antibiotics within 2 weeks (14 days) of dosing.
Active and clinically significant systemic or localized infection.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States | ||
| Memorial Sloan Kettering Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33046513 | Derived | Janku F, Zhang HH, Pezeshki A, Goel S, Murthy R, Wang-Gillam A, Shepard DR, Helgason T, Masters T, Hong DS, Piha-Paul SA, Karp DD, Klang M, Huang SY, Sakamuri D, Raina A, Torrisi J, Solomon SB, Weissfeld A, Trevino E, DeCrescenzo G, Collins A, Miller M, Salstrom JL, Korn RL, Zhang L, Saha S, Leontovich AA, Tung D, Kreider B, Varterasian M, Khazaie K, Gounder MM. Intratumoral Injection of Clostridium novyi-NT Spores in Patients with Treatment-refractory Advanced Solid Tumors. Clin Cancer Res. 2021 Jan 1;27(1):96-106. doi: 10.1158/1078-0432.CCR-20-2065. Epub 2020 Oct 12. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | 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). |
| FG001 | Cohort 2 | Patients received only single dose of C. novyi-NT spores (Cohort 2: 3 x 10^4 spores) as an IT injection, pp. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 2, 2014 | Jan 23, 2019 |
Not provided
Not provided
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|
| At screening, at follow up (at 1, 2, 4, and 8 months (±2 days) after dosing) |
| Number of Patients With RECIST Assessment on the Injected Lesion | 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. | At follow up (at 1 and 2, 4, and 8 months (±2 days) after dosing) |
| Number of Patients With Overall RECIST Response | 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. | At follow up (at 1 and 2, 4, and 8 months (±2 days) after dosing) |
| Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT | 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. | 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) |
| Number of Patients With Cytokine Responses Analyzed | 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. | 2 years |
| Number of Patients With Systemic Tumor Antigen Specific T-cell Responses | 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. | 2 years |
| Number of Patients With Local Tumor-specific T-cell Responses | 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. | 2 years |
| New York |
| New York |
| 10021 |
| United States |
| Albert Einstein College of Medicine | The Bronx | New York | 10461 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| UT M.D. Anderson Cancer Center | Houston | Texas | 77030 | United States |
| FG002 | Cohort 3 | Patients received only single dose of C. novyi-NT spores (Cohort 3: 10 x 10^4 spores) as an IT injection, pp. |
| FG003 | Cohort 4 | Patients received only single dose of C. novyi-NT spores (Cohort 4: 30 x 10^4 spores) as an IT injection, pp. |
| FG004 | Cohort 5 | Patients received only single dose of C. novyi-NT spores (Cohort 5: 100 x 10^4 spores) as an IT injection, pp. |
| FG005 | Cohort 6 | Patients received only single dose of C. novyi-NT spores (Cohort 6: 300 x 10^4 spores) as an IT injection, pp. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Cohort 1: 1 x 10^4 spores |
| BG001 | Cohort 2 | Cohort 2: 3 x 10^4 spores |
| BG002 | Cohort 3 | Cohort 3: 10 x 10^4 spores |
| BG003 | Cohort 4 | Cohort 4: 30 x 10^4 spores |
| BG004 | Cohort 5 | Cohort 5: 100 x 10^4 spores |
| BG005 | Cohort 6 | Cohort 6: 300 x 10^4 spores |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Treatment-emergent Adverse Events (TEAE) | 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 | 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. | Posted | Number | Patients | From screening until follow-up visit (up to 12 months) |
|
|
| |||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients With Adverse Events Qualified as Dose Limiting Toxicities (DLTs) | To determine the DLTs of C. novyi-NT in humans with treatment-refractory solid tumor malignancies when administered as a single IT injection. | 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. | Posted | Number | Patients | From screening until follow-up visit (up to 12 months) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage Change in Tumor Size From Baseline of the Target Injected Lesion, Measured by Computed Tomography (CT) Scans or Magnetic Resonance Imaging (MRI) Scans | 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. | 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. | Posted | Number | Percentage of change | At screening, at follow up (at 1, 2, 4, and 8 months (±2 days) after dosing) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With RECIST Assessment on the Injected Lesion | 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. | 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. | Posted | Number | Patients | At follow up (at 1 and 2, 4, and 8 months (±2 days) after dosing) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Overall RECIST Response | 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. | 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. | Posted | Number | Patients | At follow up (at 1 and 2, 4, and 8 months (±2 days) after dosing) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Positive Blood Cultures-Number of Patients With Presence of C. Novyi-NT | 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. | 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. | Posted | Number | Patients | 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) |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Cytokine Responses Analyzed | 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. | 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. | Posted | Number | Patients | 2 years |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Systemic Tumor Antigen Specific T-cell Responses | 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. | 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. | Posted | Number | Patients | 2 years |
| |||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Patients With Local Tumor-specific T-cell Responses | 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. | 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. | Posted | Number | Patients | 2 years |
|
From screening until follow-up visit (up to 12 months)
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.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Cohort 1: 1 x 10^4 spores | 0 | 3 | 1 | 3 | 3 | 3 |
| EG001 | Cohort 2 | Cohort 2: 3 x 10^4 spores | 1 | 3 | 2 | 3 | 3 | 3 |
| EG002 | Cohort 3 | Cohort 3: 10 x 10^4 spores | 0 | 4 | 1 | 4 | 4 | 4 |
| EG003 | Cohort 4 | Cohort 4: 30 x 10^4 spores | 1 | 6 | 4 | 6 | 6 | 6 |
| EG004 | Cohort 5 | Cohort 5: 100 x 10^4 spores | 0 | 6 | 3 | 6 | 6 | 6 |
| EG005 | Cohort 6 | Cohort 6: 300 x 10^4 spores | 0 | 2 | 2 | 2 | 2 | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oedema peripheral | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abdominal abscess | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gas gangrene | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Soft tissue infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Tumour haemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Phantom pain | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Genital swelling | Reproductive system and breast disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Limb salvage therapy | Surgical and medical procedures | MedDRA (14.1) | Non-systematic Assessment |
| |
| Osteosynthesis | Surgical and medical procedures | MedDRA (14.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (14.1) | Non-systematic Assessment |
|
This document contains confidential information of BioMed Valley Discoveries, Inc. Do not copy or distribute without written permission from the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brent Kreider | BioMed Valley Discoveries, Inc. | 816-960-4644 | bkreider@biomed-valley.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2017 | Jan 23, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009369 | Neoplasms |
| D000860 | Hypoxia |
| D009336 | Necrosis |
| D012509 | Sarcoma |
| D002817 | Chordoma |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009373 | Neoplasms, Germ Cell and Embryonal |
Not provided
Not provided
| ID | Term |
|---|---|
| D058491 | Bacterial Load |
| ID | Term |
|---|---|
| D001431 | Bacteriological Techniques |
| D008828 | Microbiological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D015169 | Colony Count, Microbial |
| D008919 | Investigative Techniques |
| D018407 | Bacterial Physiological Phenomena |
| D008827 | Microbiological Phenomena |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Related TEAEs |
|
| CTCAE Grade 1 TEAEs |
|
| CTCAE Grade 2 TEAEs |
|
| CTCAE Grade 3 TEAEs |
|
| Life-Threatening TEAEs |
|
| Deaths |
|
| Serious TEAEs |
|
Cohort 5: 100 x 10^4 spores
| OG005 | Cohort 6 | Cohort 6: 300 x 10^4 spores |
|
|
Cohort 3: 10 x 10^4 spores |
| OG003 | Cohort 4 | Cohort 4: 30 x 10^4 spores |
| OG004 | Cohort 5 | Cohort 5: 100 x 10^4 spores |
| OG005 | Cohort 6 | Cohort 6: 300 x 10^4 spores |
|
|
Cohort 3: 10 x 10^4 spores
| OG003 | Cohort 4 | Cohort 4: 30 x 10^4 spores |
| OG004 | Cohort 5 | Cohort 5: 100 x 10^4 spores |
| OG005 | Cohort 6 | Cohort 6: 300 x 10^4 spores |
|
|
| OG004 |
| Cohort 5 |
Cohort 5: 100 x 10^4 spores |
| OG005 | Cohort 6 | Cohort 6: 300 x 10^4 spores |
|
|
| OG004 | Cohort 5 | Cohort 5: 100 x 10^4 spores |
| OG005 | Cohort 6 | Cohort 6: 300 x 10^4 spores |
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| OG004 | Cohort 5 | Cohort 5: 100 x 10^4 spores |
| OG005 | Cohort 6 | Cohort 6: 300 x 10^4 spores |
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Cohort 5: 100 x 10^4 spores
| OG003 | Cohort 6 | Cohort 6: 300 x 10^4 spores |
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| OG003 | Cohort 6 | Cohort 6: 300 x 10^4 spores |
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