Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer

Study Overview
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Brief Summary
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This is a phase 2b, double-blind, placebo-controlled, 4-arm, adaptive-design trial, initially stratified by cisplatin regimen, and then randomized 1:1:1:1. The study will be conducted in subjects receiving ChemoRT for the treatment of squamous cell carcinomas (SCCs) of the oral cavity, oropharynx, hypopharynx, or larynx. The study includes a treatment period of approximately 7 weeks, depending on the subject's prescribed radiation plan, and Week 1 and Week 4 post RT follow-up visits. It also includes a longer follow-up period of approximately 12 months to determine if there is an effect of SCV 07 on the tumor response to ChemoRT.

Official Title
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A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Three Different Doses of SCV 07 in Attenuating Oral Mucositis in Subjects With Head and Neck Cancer Receiving Concurrent Chemotherapy and Radiotherapy

Conditions
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Oral Mucositis

Intervention / Treatment
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* Drug: SCV-07
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to understand and sign an informed consent form (ICF) for the study approved by the Investigator's local or a central Institutional Review Board (IRB) Have recently diagnosed, pathologically confirmed, non-metastatic SCC of the oral cavity, oropharynx, hypopharynx, or larynx that will be treated with ChemoRT as first-line treatment; subjects with a history of surgical management are eligible Have a plan 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 50 and 72 Gy. Planned radiation treatment fields must include at least 2 oral sites (buccal mucosa, floor of oral cavity, tongue, or soft palate), with each site receiving ≥ 50 Gy Have a plan to receive a standard cisplatin CT regimen administered tri-weekly (80 to 100 mg/m2, on Days 0, 21, and 42) or weekly (30 to 40 mg/m2) Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 Have adequate hematopoietic, hepatic, and renal function at the screening visit: Hematopoietic function Hemoglobin ≥ 10 g/dL Absolute neutrophil counts (ANC) ≥ 1,500 cells/mm3 Platelet count ≥ 100 × 109/L Hepatic function Total bilirubin < 1.5 times the upper-normal limit (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 times the ULN Renal function: Serum creatinine concentration ≤ 2 mg/dL; if result is ≥ 1.4 mg/dL and ≤ 2.0 mg/dL, a 24-hour urinary creatinine clearance test must be performed by the site's local laboratory. To be eligible for the study, a subject must demonstrate a 24-hour urinary creatinine clearance ≥ 50 mL/min Have a negative serum pregnancy test if a woman is of childbearing potential Agree to use medically acceptable methods of birth control during study participation and for 30 days following the last CTM treatment if a woman is of childbearing potential Males or females aged 18 years or older. Exclusion Criteria: Tumor of the lips, sinuses, salivary glands, nasopharynx, or unknown primary tumor Metastatic disease (M1) Stage IV C Prior radiation to the head and neck Plan to be treated with cetuximab (Erbitux®) Have undergone induction CT History of other malignant tumors, excluding non-melanoma skin cancer or curatively excised in situ cervical carcinoma Have had a major surgical procedure, other than for HNC, or significant traumatic injury within 4 weeks prior to the initiation of RT; anticipation of need for a major surgical procedure during the study Active infectious disease, excluding oral candidiasis Have OM at the baseline visit Have a diagnosis of autoimmune disease requiring chronic immunosuppression Known seropositivity for HIV, HBV, or HCV Prior use of SCV 07 Have used any investigational agent within 30 days of randomization Are pregnant or breastfeeding Known allergies or intolerance to cisplatin Unable to give informed consent or comply with study requirements, including completing the subject diary and QOL instruments Have any other condition or therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with follow-up visits.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: SCV-07 0.1mg/kg<br> | Drug: SCV-07<br>* clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc<br>|
| Active Comparator: SCV-07 0.3mg/kg<br> | Drug: SCV-07<br>* clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc<br>|
| Active Comparator: SCV-07 1.0mg/kg<br> | Drug: SCV-07<br>* clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | The primary objective of the study is to evaluate the efficacy of SCV 07 in modifying the course of oral mucositis (OM) in subjects with head and neck cancer (HNC) receiving concurrent ChemoRT. | June 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | The secondary objective of the study is to evaluate the safety and tolerability of SCV 07. | June 2012 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral Mucositis, Head and Neck, Head and Neck Neoplasms, Mucositis, Stomatitis, Neoplasms by Site, Neoplasms, Gastroenteritis, Gastrointestinal Diseases, Digestive System Diseases, Mouth Diseases, Stomatognathic Diseases, SCV-07