Neoplasms

All Conditions

Mouth and Tooth Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Stomatitis

Mucositis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Oral Squamous Cell Carcinoma

Patients are randomized 1:1 active/placebo.

1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.

SGX942

Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.

Placebo

To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer

DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer

A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis (SOM; defined as World Health Organization \[WHO\] Grade ≥3). Duration of SOM is defined as the number of days from the onset of SOM until resolution of SOM. OM is evaluated using the published WHO OM grading scale that uses a scale of 0 to 4, with SOM defined as a score ≥3.

Soligenix

Patients are randomized 1:1 active/placebo.

SGX942: 1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.

Patients are randomized 1:1 active/placebo.

Placebo: Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

HPV Status

The baseline analysis population was defined as all participants that were treated with at least one dose of treatment (SGX942 or Placebo)

Richard Straube, MD/Chief Medical Officer

The analysis population was defined as all participants receiving a minimum of 55 Gray of cumulative radiation.

Duration of Severe Oral Mucositis (SOM)

Overall Study

Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg

To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer

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

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.

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.

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

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.

1.5 mg/kg

3.0 mg/kg

6.0 mg/kg

Age, Categorical

United States

Region of Enrollment

Dr. Richard Straube

Residual Severe Oral Mucositis (SOM)

Incidence of Clinically Reported, Non-fungal Infections

Percent of Patients With RECIST 1.1 Classification of "Complete Response"

Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin

Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin

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.

Survival

Administered as a 4-minute intravenous (IV) infusion, every 3 days (±1 day) while receiving radiation therapy to a maximum of 14 doses

Spots Global Cancer Trial Database for sgx942

Every month we try and update this database with for sgx942 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer	NCT03237325	Squamous Cell C... Oral Mucositis	SGX942 Placebo	18 Years -	Soligenix
DOM-INNATE: Study of SGX942 for the Treatment of Oral Mucositis in Patients With Concomitant Chemoradiation Therapy for Head and Neck Cancer	NCT03237325	Squamous Cell C... Oral Mucositis	SGX942 Placebo	18 Years -	Soligenix
A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer	NCT02013050	Oral Mucositis	SGX942 Placebo	18 Years -	Soligenix
A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer	NCT02013050	Oral Mucositis	SGX942 Placebo	18 Years -	Soligenix
A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer	NCT02013050	Oral Mucositis	SGX942 Placebo	18 Years -	Soligenix

Spots Global Cancer Trial Database for sgx942

Every month we try and update this database with for sgx942 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sgx942 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.