Efficacy of SNX-1012 in the Treatment of Oral Mucositis

Inclusion Criteria

• •Signed written informed consent
• •Naive to focal radiation therapy in the head and neck regions for cancer prior to CT Cycle 1. Subjects with prior or concomitant radiation therapy to areas other than the head and neck may be enrolled.
• •Histologically confirmed diagnosis of breast or lung cancer (NSCLC or SCLC)
• •Chemotherapy regimen containing AC ± T or EC ± T (for breast cancer), cisplatin or carboplatin (for NSCLC or SCLC), or doxorubicin (for SCLC)
• •Subjects will receive the same regimen and dose of CT in the OM Treatment CT Cycle as was administered in the immediately preceding CT Cycle.
• •Subjects will have had OM of WHO Grade of greater than or equal to 2 during CT Cycle 1 or Cycle 2
• •Subjects 18 years and older
• •Karnofsky Performance Score \>=60
• •Baseline laboratory assessments:
• •Hemoglobin (Hgb) level \>= 9 g/dL Absolute neutrophil count (ANC) \>= 1.5 x 10 to the 9/L Platelet count \>= 100 x 10 to the 9/L Serum bilirubin level \<= 1.5 times institutional upper limit of normal (ULN) Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) level \<= 2 times above ULN
• •Females of childbearing potential must have a negative serum or urine pregnancy test result at the screening visit prior to the start of Cycle 1 and at the visit scheduled for \<= 48 hours prior to the start of the OM Treatment CT Cycle
• •Subjects with reproductive capability must agree to practice adequate contraception methods (males must use condoms or be surgically sterilized; females must be surgically sterilized, post-menopausal for at least 1 year, or use an appropriate double barrier method, prescribed birth control oral contraceptive, patch, implant, or injection during the course of the study and for up to 30 days after completion of study assessments)
• •Absence of other serious concurrent medical illness
• •Psychologically able to participate and comply with study requirements