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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02013050
First Posted: December 17, 2013
Last Update Posted: August 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Soligenix
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: December 11, 2013
First Posted: December 17, 2013
Results First Submitted: February 17, 2017
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