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

Primary Purpose

Oral Mucositis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SGX942
Placebo
Sponsored by
Soligenix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oral Mucositis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Markey Cancer Center-University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

SGX942

Arm Description

Control

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Incidence of Clinically Reported, Non-fungal Infections
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
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
Survival
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

Full Information

First Posted
December 11, 2013
Last Updated
July 28, 2017
Sponsor
Soligenix
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1. Study Identification

Unique Protocol Identification Number
NCT02013050
Brief Title
A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soligenix

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Control
Arm Title
SGX942
Arm Type
Experimental
Arm Description
Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg
Intervention Type
Drug
Intervention Name(s)
SGX942
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Duration of Severe Oral Mucositis (SOM)
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.
Time Frame
4 weeks after end of therapy
Secondary Outcome Measure Information:
Title
Residual Severe Oral Mucositis (SOM)
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.
Time Frame
4 weeks after end of therapy
Title
Duration of Severe Oral Mucositis (SOM)
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.
Time Frame
4 weeks after end of therapy
Title
Incidence of Clinically Reported, Non-fungal Infections
Time Frame
4 weeks after end of therapy
Title
Percent of Patients With RECIST 1.1 Classification of "Complete Response"
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
Time Frame
4 weeks after end of therapy
Title
Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin
Time Frame
4 weeks after end of therapy
Title
Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin
Time Frame
4 weeks after end of therapy
Title
Survival
Time Frame
12 months after end of therapy
Title
Percent of Patients With RECIST 1.1 Classification of "Complete Response"
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
Time Frame
12 months after end of therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Markey Cancer Center-University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

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

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