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To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Control |
|
| SGX942 | Experimental | Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGX942 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Severe Oral Mucositis (SOM) | Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. | 4 weeks after end of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Residual Severe Oral Mucositis (SOM) | OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3. | 4 weeks after end of therapy |
| Duration of Severe Oral Mucositis (SOM) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Markey Cancer Center-University of Kentucky | Lexington | Kentucky | 40536 | United States |
Two patients were randomized but never received study drug and are excluded from the analyses
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses |
| FG001 | 1.5 mg/kg | Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses |
| FG002 | 3.0 mg/kg | Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses |
| FG003 | 6.0 mg/kg | Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | |
| BG001 | 1.5 mg/kg | |
| BG002 | 3.0 mg/kg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Duration of Severe Oral Mucositis (SOM) | Duration of SOM was defined as the number of days from the onset of SOM until resolution of SOM. If the patient did not meet the requirements for resolution of SOM by the 1-month follow up visit, he/she was considered censored at the 1-month follow-up visit (or point of discontinuation of the study, if the patient had discontinued prior to the end of planned treatment). Patients who did not experience SOM were assigned a duration of 0.01. OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. | Posted | Median | 95% Confidence Interval | days | 4 weeks after end of therapy |
|
From the time of enrollment up until four weeks (±5 days) following the last study drug treatment.
Safety analyses were performed on the Safety Population which is comprised of all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug they actually received instead of the drug dose to which they were randomized. 2 patients were randomized but never received drug and are excluded from the analyses. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942 and is included in the 1.5 mg/kg treatment group in all safety analyses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 8 | 43 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Straube | Soligenix, Inc. | rstraube@soligenix.com |
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| ID | Term |
|---|---|
| D013280 | Stomatitis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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|
OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3. |
| 4 weeks after end of therapy |
| Incidence of Clinically Reported, Non-fungal Infections | 4 weeks after end of therapy |
| Percent of Patients With RECIST 1.1 Classification of "Complete Response" | The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows: Target Lesion : Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR Non-Target Lesion: Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions | 4 weeks after end of therapy |
| Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin | 4 weeks after end of therapy |
| Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin | 4 weeks after end of therapy |
| Survival | 12 months after end of therapy |
| Percent of Patients With RECIST 1.1 Classification of "Complete Response" | The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows: Target Lesion : Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR Non-Target Lesion: Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions | 12 months after end of therapy |
| BG003 | 6.0 mg/kg |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| 3.0 mg/kg |
| OG003 | 6.0 mg/kg |
|
|
| Secondary | Residual Severe Oral Mucositis (SOM) | OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3. | Posted | Number | percentage of participants | 4 weeks after end of therapy |
|
|
|
| Secondary | Duration of Severe Oral Mucositis (SOM) | OM was evaluated using the published World Health Organization (WHO) OM grading scale that uses a scale of 0 to 4. SOM is defined as a WHO score of greater than or equal to 3. | Posted | Median | 95% Confidence Interval | WHO score * days | 4 weeks after end of therapy |
|
|
|
| Secondary | Incidence of Clinically Reported, Non-fungal Infections | Posted | Number | percentage of participants | 4 weeks after end of therapy |
|
|
|
| Secondary | Percent of Patients With RECIST 1.1 Classification of "Complete Response" | The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows: Target Lesion : Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR Non-Target Lesion: Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions | Posted | Number | percentage of participants | 4 weeks after end of therapy |
|
|
|
| Secondary | Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin | Posted | Median | 95% Confidence Interval | days | 4 weeks after end of therapy |
|
|
|
| Secondary | Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin | Posted | Number | percentage of participants | 4 weeks after end of therapy |
|
|
|
| Secondary | Survival | Safety Population: all patients randomized who received at least 1 dose of study drug and were included in the dose group of the drug that they actually received instead of the drug dose they were randomized. 2 patients were randomized but never received drug and are excluded. 1 patient was randomized to placebo but received 1.5 mg/kg SGX942. | Posted | Number | percentage of participants | 12 months after end of therapy |
|
|
|
| Secondary | Percent of Patients With RECIST 1.1 Classification of "Complete Response" | The RECIST 1.1 scoring system evaluates both the defined (target) tumor, the non-target lesions, and the appearance of new lesions on radiologic scans as follows: Target Lesion : Complete Response (CR): All target lesions gone Partial Response (PR): >30% decrease from Baseline Progressive Disease (PD): >20% increase from smallest sum of longest diameter recorded since treatment started (best response) Stable Disease (SD): Neither PD nor PR Non-Target Lesion: Complete Response (CR): All non-target lesions gone,Tumor markers gone Stable Disease (SD): Persistence of ≥1 non-target lesion, Tumor marker level elevated Progressive Disease: Enlargement of non-target lesions | Posted | Number | percentage of participants | 12 months after end of therapy |
|
|
|
| 25 |
| 41 |
| 41 |
| 41 |
| EG001 | 1.5 mg/kg | 3 | 41 | 25 | 42 | 42 | 42 |
| EG002 | 3.0 mg/kg | 0 | 3 | 1 | 3 | 3 | 3 |
| EG003 | 6.0 mg/kg | 4 | 24 | 16 | 23 | 23 | 23 |
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| White blood cell disorder | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Disease progression | General disorders | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | Non-systematic Assessment |
|
| Device related infection | Infections and infestations | Non-systematic Assessment |
|
| Empyema | Infections and infestations | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Lobar pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia klebsiella | Infections and infestations | Non-systematic Assessment |
|
| Post procedural infection | Infections and infestations | Non-systematic Assessment |
|
| Sepsis | Infections and infestations | Non-systematic Assessment |
|
| Staphylococcal bacteraemia | Infections and infestations | Non-systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Feeding tube complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Abnormal loss of weight | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Failure to thrive | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypochloraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypovolaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Mental status changes | Psychiatric disorders | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Embolism | Vascular disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Peripheral artery thrombosis | Vascular disorders | Non-systematic Assessment |
|
| Blood disorder | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Febrile neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Neutrophil function disorder | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Platelet disorder | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| White blood cell disorder | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Hearing impaired | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | Non-systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Odynophagia | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oesophageal stenosis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Oral pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Saliva altered | Gastrointestinal disorders | Non-systematic Assessment |
|
| Salivary duct inflammation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Asthenia | General disorders | Non-systematic Assessment |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Fatigue | General disorders | Non-systematic Assessment |
|
| Malaise | General disorders | Non-systematic Assessment |
|
| Medical device complication | General disorders | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | Non-systematic Assessment |
|
| Pyrexia | General disorders | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | Non-systematic Assessment |
|
| Candida infection | Infections and infestations | Non-systematic Assessment |
|
| Fungal infection | Infections and infestations | Non-systematic Assessment |
|
| Oral candidiasis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | Non-systematic Assessment |
|
| Radiation skin injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Abnormal loss of weight | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hyponatraemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Malnutrition | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Trismus | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Ageusia | Nervous system disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | Non-systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal disorder | Renal and urinary disorders | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hiccups | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
There were limitations put on the sites from publishing data until the sponsor had published data. That data is now published.