Oral Mucositis in Patients Being Treated with Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck MedDRA version: 20.0 Level: LLT Classification code 10028130 Term: Mucositis oral System Organ Class: 100000004856
Conditions
Interventions
Product Name: Dusquetide
Product Code: SGX942
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Dusquetide
CAS Number: Not assigned
Current Sponsor code: SGX942
Other descriptive name: S
Sponsors
Soligenix UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Willing and able to understand and sign an informed consent 2. Males or females age greater than or equal to 18 years 3. Biopsy-proven squamous cell carcinoma of the oral cavity or oropharynx without distant organ metastases that has been evaluated for human papillomavirus (HPV) 4. Scheduled to receive cisplatin chemotherapy of 80-100 mg/m² given every third week 5. Scheduled to receive a continuous course of conventional external beam irradiation delivered by intensity-modulated radiotherapy (IMRT) as single daily fractions of 2.0 to 2.2 Gy, with a cumulative radiation dose between 55 and 72 Gy at each site 6. Planned radiation treatment fields must include at least 2 oral sites (retromolar trigone, buccal mucosa, floor of mouth, tongue, or soft palate), with each site receiving =55 Gy 7. All women of childbearing potential (WOCBP) and males with female partners who are WOCBP must agree to the use of effective contraception during the trial. • Women are considered to be WOCBP following menarche and until becoming post-menopausal unless permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Effective contraception methods for WOCBP should be started prior to randomization and continued for a minimum of 35 days following completion of study drug administration. • Acceptable contraceptive methods for WOCBP are those that achieve a failure rate of less than 1% per year and include: o Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (Oral, Intravaginal, Transdermal) o Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable) o Intrauterine device (IUD) o Intrauterine hormone-releasing system (IUS) o Bilateral tubal occlusion o Vasectomised partner o Sexual abstinence defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments • Male subjects should use condoms during treatment and for 98 days following the last study drug administration period. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 147 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 43
Exclusion criteria
Exclusion criteria: Patients with any of the following criteria are NOT eligible for enrollment: 1. Current mucositis 2. Current, clinically significant, active infection that in the opinion of the Investigator would make them an unfit participant in the trial 3. Planned to receive Erbitux™ (Cetuximab) or similar targeted therapy between Baseline and 6 weeks post-RT 4. Current use of prohibited therapies listed in Section 8.2 5. Prior radiation to the head and neck 6. Chemotherapy treatment within the previous 12 months 7. Tumors of the lips, sinuses, salivary glands, nasopharynx, hypopharynx, or larynx 8. Evidence of significant renal, hepatic, hematologic, or immunologic disease determined by any one of the following: A. Estimated creatinine clearance <30 mL/min B. ALT or AST level greater than 10-fold the upper limit of normal or total bilirubin greater than 3-fold the upper limit of normal C. Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy D. Thrombocytopenia (less than 60,000 cells/mm3) E. CD4+ T cell count below 200 cells per µL 9. Evidence of immediate life-threatening disease or a life expectancy of less than 3 months 10. Women who are pregnant or breast-feeding 11. Participation in any study involving administration of an investigational agent within 30 days of randomization into this study 12. Any condition that, in the opinion of the Investigator, would compromise the safety of the subject or quality of the data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis (SOM; defined as World Health Organization [WHO] Grade lesion =3) in patients receiving fractionated radiation treatments and concomitant cisplatin chemotherapy, given as 80-100 mg/m2 every third week, for the treatment of squamous cell carcinoma of the oral cavity or oropharynx.;Secondary Objective: To assess the impact of SGX942 compared to placebo on the following clinically important secondary objectives: 1. To assess the impact that SGX942 has on the Area-Under-the-Curve (AUC) for SOM (WHO Grade =3) by time plot (severity-weighted duration) 2. To assess the impact that SGX942 has on the Area-Under-the-Curve (AUC) for ulcerative oral mucositis (UOM; defined as WHO Grade =2) by time plot (severity-weighted duration) 3. To assess the impact that SGX942 has on the incidence of SOM 4. To assess the impact that SGX942 has on the quality of life assessment using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Question for Head and Neck Cancer 43 question (QLQH& N43) instrument 5. To assess the impact that SGX942 has on the amount of opioids used;Primary end point(s): The primary efficacy outcome for this study is the duration of SOM, defined as the number of days from the first oral examination with a WHO Grade assessment of =3 until the first time the patient has a WHO Grade of <3 with no subsequent readings =3.;Timepoint(s) of evaluation of this end point: Clinical evaluation of mucositis will be performed and graded by trained study evaluators in accordance with WHO Oral Mucositis Grading system at each study drug administration visit, which is twice a week to a maximum of 9 weeks, and thereafter once a week through 6 weeks post-RT (see Table 7 of Protocol) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Please refer to Table 7 of the protocol and section 10.2. Secondary Efficacy Endpoints.;Secondary end point(s): Secondary endpoints will be analyzed in hierarchical order: 1. The Area-Under-the-Curve (AUC) for SOM (WHO Grade =3) by time plot (severity-weighted duration) 2. The Area-Under-the-Curve (AUC) for ulcerative oral mucositis (UOM; defined as WHO Grade =2) by time plot (severity-weighted duration) 3. The incidence of SOM 4. The quality of life assessment using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Question for Head and Neck Cancer 43 question (QLQH& N43) instrument 5. The amount of opioids used The following secondary endpoints will also be examined: • The cumulative number of days of radiation treatment breaks • The duration of SOM in patients receiving a cumulative minimum of 55 Gy of fractionated RT and concomitant cisplatin chemotherapy, given as 80-100 mg/m2 every third week (mITT population) • The duration of UOM • The cumulative amount of pain reported by patients • The duration of SOM using an alternative definition calculated as the number of days from the first oral examination with WHO grade =3 through the last assessment with a WHO score =3 (and not to the first assessment with a WHO grade <3) with no further reports of a WHO grade =3. • The duration of SOM in the Per-Protocol Population defined as patients receiving a cumulative radiation dose of at least 55 Gy and all scheduled study drug. Safety: • The incidence, type, and body system categorization of AEs • The incidence, type, and body system categorization of SAEs • The changes from Baseline for hematology parameters, clinical chemistry parameters, and vital signs • Tumor status at 12 weeks and 12 months following completion of RT categorized using the RECIST criteria • The incidence and severity of reported infections assessed by CTCAE grading • The 12 month post-RT survival | — |
Countries
Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, United Kingdom, United States
Contacts
Public ContactRichard Straube, MD
Soligenix, Inc.
Outcome results
None listed