Phase 2
N=109
A Dose Escalating Study of SGX942 for Oral Mucositis in Patients With Head and Neck Cancer
Oral Mucositis
Bottom Line
View on ClinicalTrials.gov: NCT02013050 ↗Enrolled (actual)
109
Serious AEs
61.5%
Results posted
Jul 2017
Primary outcome: Primary: Duration of Severe Oral Mucositis (SOM) — 18; 9; 14; 22 days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SGX942 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Soligenix
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Severe Oral Mucositis (SOM) |
35.5; 21.8; 33.0; 46.5 | — |
| SECONDARY Residual Severe Oral Mucositis (SOM) |
21; 6; 33; 16 | — |
| SECONDARY Duration of Severe Oral Mucositis (SOM) |
35.5; 21.8; 33.0; 46.5 | — |
| SECONDARY Incidence of Clinically Reported, Non-fungal Infections |
45; 28; 0; 21 | — |
| SECONDARY Percent of Patients With RECIST 1.1 Classification of "Complete Response" |
53; 53; 33; 53 | — |
| SECONDARY Duration of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin |
30; 10; 14; 17 | — |
| SECONDARY Incidence of Severe Oral Mucositis (SOM) in Patients Receiving Every 3rd Week Cisplatin |
82; 67; 67; 80 | — |
| SECONDARY Survival |
81; 93; 100; 83 | — |
| SECONDARY Percent of Patients With RECIST 1.1 Classification of "Complete Response" |
53; 53; 33; 53 | — |
Summary
To evaluate the safety and efficacy of SGX942 in patients receiving chemoradiation treatment for the treatment of head and neck cancer.
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.
Data sourced from ClinicalTrials.gov (NCT02013050). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.