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

• ClinicalTrials.gov Identifier: NCT02013050
• Recruitment Status: Completed
• First Posted: December 17, 2013
• Results First Posted: July 31, 2017
• Last Update Posted: August 28, 2017
• Sponsor: Soligenix
• Information provided by (Responsible Party): Soligenix

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Oral Mucositis	Drug: SGX942; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: December 2013
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: September 2016

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Control	Drug: Placebo
Experimental: SGX942; Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg	Drug: SGX942

Outcome Measures

Primary Outcome Measures :

1. Duration of Severe Oral Mucositis (SOM) [ Time Frame: 4 weeks after end of therapy ]
   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.

Secondary Outcome Measures :

1. Residual Severe Oral Mucositis (SOM) [ Time Frame: 4 weeks after end of therapy ]
   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.
2. Duration of Severe Oral Mucositis (SOM) [ Time Frame: 4 weeks after end of therapy ]
   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.
3. Incidence of Clinically Reported, Non-fungal Infections [ Time Frame: 4 weeks after end of therapy ]
4. Percent of Patients With RECIST 1.1 Classification of "Complete Response" [ Time Frame: 4 weeks after end of therapy ]

   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

5. Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin [ Time Frame: 4 weeks after end of therapy ]
6. Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin [ Time Frame: 4 weeks after end of therapy ]
7. Survival [ Time Frame: 12 months after end of therapy ]
8. Percent of Patients With RECIST 1.1 Classification of "Complete Response" [ Time Frame: 12 months after end of therapy ]

   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, Kentucky

Markey Cancer Center-University of Kentucky

Lexington, Kentucky, United States, 40536

Sponsors and Collaborators

Soligenix

More Information

• Responsible Party: Soligenix
• ClinicalTrials.gov Identifier: NCT02013050
• Other Study ID Numbers: IDR-OM-01
• First Posted: December 17, 2013
• Results First Posted: July 31, 2017
• Last Update Posted: August 28, 2017
• Last Verified: July 2017

Additional relevant MeSH terms:

Mucositis; Stomatitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases