Brief Summary
To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.
Brief Title
A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer
Categories
Completion Date
Completion Date Type
Actual
Conditions
Oral Mucositis
Eligibility Criteria
Inclusion Criteria:
* Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
* Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
* Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
* Must be able to read and understand informed consent
* Adequate birth control methods for the duration of the study
Exclusion Criteria:
* Current mucositis.
* Prior radiation to the head and neck.
* Chemotherapy treatment within the previous 12 months.
* Tumors of the lips, sinuses, salivary glands or nasopharynx.
* Unknown primary tumor.
* Stage 4c metastases.
* Evidence of significant hepatic, hematologic, or immunologic disease.
* Women who are pregnant or breast-feeding.
* Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
* Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
* Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
* Must be able to read and understand informed consent
* Adequate birth control methods for the duration of the study
Exclusion Criteria:
* Current mucositis.
* Prior radiation to the head and neck.
* Chemotherapy treatment within the previous 12 months.
* Tumors of the lips, sinuses, salivary glands or nasopharynx.
* Unknown primary tumor.
* Stage 4c metastases.
* Evidence of significant hepatic, hematologic, or immunologic disease.
* Women who are pregnant or breast-feeding.
Inclusion Criteria
Inclusion Criteria:
* Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
* Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
* Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
* Must be able to read and understand informed consent
* Adequate birth control methods for the duration of the study
* Biopsy-proven non-metastatic squamous cell carcinoma of the mouth or oropharynx and is planned to receive a standard course of concomitant CRT.
* Patients who have received surgery are eligible if surgery is performed within 6 weeks prior to study initiation.
* Planned to receive standard cisplatin chemotherapy administered either weekly or every third week.
* Must be able to read and understand informed consent
* Adequate birth control methods for the duration of the study
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02013050
Org Class
Industry
Org Full Name
Soligenix
Org Study Id
IDR-OM-01
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Phase 2,Double-Blind, Randomized, Placebo-Controlled, Dose Escalating, Multicenter Study of SGX942 For the Attenuation of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck
Primary Outcomes
Outcome Description
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.
Outcome Measure
Duration of Severe Oral Mucositis (SOM)
Outcome Time Frame
4 weeks after end of therapy
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
4 weeks after end of therapy
Outcome Measure
Residual Severe Oral Mucositis (SOM)
Outcome Description
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.
Outcome Time Frame
4 weeks after end of therapy
Outcome Measure
Duration of Severe Oral Mucositis (SOM)
Outcome Time Frame
4 weeks after end of therapy
Outcome Measure
Incidence of Clinically Reported, Non-fungal Infections
Outcome Description
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
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
Outcome Time Frame
4 weeks after end of therapy
Outcome Measure
Percent of Patients With RECIST 1.1 Classification of "Complete Response"
Outcome Time Frame
4 weeks after end of therapy
Outcome Measure
Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin
Outcome Time Frame
4 weeks after end of therapy
Outcome Measure
Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin
Outcome Time Frame
12 months after end of therapy
Outcome Measure
Survival
Outcome Description
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
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
Outcome Time Frame
12 months after end of therapy
Outcome Measure
Percent of Patients With RECIST 1.1 Classification of "Complete Response"
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Madhur Garg
Investigator Email
mgarg@montefiore.org
Investigator Phone
Categories Mesh Debug
Digestive System --- STOMATITIS
Digestive System --- MOUTH DISEASES
Digestive System --- STOMATOGNATHIC DISEASES
MeSH Terms
STOMATITIS
MOUTH DISEASES
STOMATOGNATHIC DISEASES
COUNTERFEIT DRUGS
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS