E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028130 |
E.1.2 | Term | Mucositis oral |
|
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy and safety of SBG when administered from 1 day prior to 5 days after completion of radiotherapy. |
|
E.2.2 | Secondary objectives of the trial |
• Compare the time from commencement of radiotherapy to onset of oral mucositis grade 3 or 4 in the SBG and placebo groups. • Compare the duration of oral mucositis grade 3 or 4 in the SBG and placebo groups. • Compare the overall incidence of oral mucositis grade 2, 3 and 4 in the SBG and placebo groups.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. ≥18 years of age; 2. Patients with histologically confirmed carcinoma of the oral cavity, oropharynx, hypopharynx, supraglottic larynx, salivary glands or maxillary sinus; 3. Scheduled to receive an either conventional or altered fractionation external beam radiotherapy regimen for their head and neck cancer with or without concurrent chemotherapy; 4. At least two visible oral cavity anatomical sites must be included in the radiotherapy treatment volume and planned to receive a total radiation dose of 54 Gy or higher; 5. Normal oral mucosa at baseline (i.e. National Cancer Institute Common Toxicity Criteria [NCI-CTC] oral mucositis grade 0); 6. Karnofsky score performance status ≥70% 7. Female patients must have a negative serum pregnancy test prior to receiving study medication, unless they have had a hysterectomy, or have been post-menopausal for at least 1 year. Women with child bearing capacity must agree to use a medically accepted form of contraception throughout the study period; 8. Willing and able to provide written informed consent for study participation; 9. Willing and able to complete other protocol-specified evaluations according to the study schedule.
|
|
E.4 | Principal exclusion criteria |
1. Previous head and neck cancer; 2. History of, or clinical evidence of active significant acute or chronic conditions that may compromise the ability to evaluate or interpret the effects of the study treatment on mucositis: i. Symptomatic and/or uncontrolled cardiac disease, New York Heart Association (NYHA) grade III/IV, transmural myocardial infarction or stroke within the last 6 months; ii. Known sero-positivity for hepatitis B or hepatitis C virus (testing not required for study entry); iii. Known sero-positivity for human immunodeficiency virus (HIV) or patients with acquired immune deficiency syndrome (AIDS) (testing not required for study entry); iv. Acute bacterial or fungal infection requiring intravenous antibiotics at study entry; v. Immunology disorders such as scleroderma or any other medical condition requiring chronic use of systemic corticosteroids. 3. Patients expected to receive other oral mucositis treatment or preventative agents during the study as described in Section 7.3 Prohibited Medication; 4. Patients who received previous radiotherapy in the head and neck area; 5. Patients who received chemotherapy within the past 6 months before screening; 6. Receipt of any investigational product within 30 days prior to this study; 7. Any patient who, in the opinion of the Investigator, is unlikely to comply with the study procedures, or is unlikely to complete the study due to different reasons e.g. language barriers or mental incapacity; 8. Pregnancy or breastfeeding.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Incidence of oral mucositis CTC grade 3 or 4 at any time from commencement of radiotherapy up to 5 days after radiotherapy ceases |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |