This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soligenix
ClinicalTrials.gov Identifier:
NCT02013050
First received: December 11, 2013
Last updated: July 28, 2017
Last verified: July 2017
  Purpose
To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.

Condition Intervention Phase
Oral Mucositis Drug: SGX942 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Soligenix:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • Incidence of Clinically Reported, Non-fungal Infections [ Time Frame: 4 weeks after end of therapy ]
  • 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


  • Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin [ Time Frame: 4 weeks after end of therapy ]
  • Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin [ Time Frame: 4 weeks after end of therapy ]
  • Survival [ Time Frame: 12 months after end of therapy ]
  • 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



Enrollment: 111
Study Start Date: December 2013
Study Completion Date: September 2016
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02013050

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     History of Changes
Other Study ID Numbers: IDR-OM-01
Study First Received: December 11, 2013
Results First Received: February 17, 2017
Last Updated: July 28, 2017

Additional relevant MeSH terms:
Mucositis
Stomatitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 21, 2017