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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01247246
• Date of registration: 22/11/2010
• Primary sponsor: SciClone Pharmaceuticals
• Public title: 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
• Scientific title: 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
• Date of first enrolment: December 2010
• Target sample size: 160
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01247246
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Israel Rios, MD
• Affiliation: SciClone Pharmaceuticals

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Oral Mucositis

Intervention(s)

Drug: Placebo

Drug: SCV-07

Primary Outcome(s)

Efficacy [Time Frame: June 2012]

Secondary Outcome(s)

Safety [Time Frame: June 2012]

Secondary ID(s)

SCI-SCV-MUC-P2b-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors