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Trial record 2 of 2 for:    SGX942

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

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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:
Information provided by (Responsible Party):
Soligenix

Tracking Information
First Submitted Date  ICMJE December 11, 2013
First Posted Date  ICMJE December 17, 2013
Results First Submitted Date  ICMJE February 17, 2017
Results First Posted Date  ICMJE July 31, 2017
Last Update Posted Date August 28, 2017
Study Start Date  ICMJE December 2013
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 16, 2013)
Oral Mucositis Symptoms [ Time Frame: 4 weeks after end of therapy ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer
Official Title  ICMJE 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
Brief Summary To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Oral Mucositis
Intervention  ICMJE
  • Drug: SGX942
  • Drug: Placebo
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Control
    Intervention: Drug: Placebo
  • Experimental: SGX942
    Investigational Drug i) 1.5 mg/kg ii) 3.0 mg/kg iii) 6.0 mg/kg
    Intervention: Drug: SGX942
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2017)
111
Original Estimated Enrollment  ICMJE
 (submitted: December 16, 2013)
78
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02013050
Other Study ID Numbers  ICMJE IDR-OM-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Soligenix
Study Sponsor  ICMJE Soligenix
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Soligenix
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP