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 2 times above ULN

• Currently receiving an investigational agent, planning to receive an investigational agent during the study period, or received an investigational agent within 30 days of the first dose of SNX-1012
• Use of an immunosuppressive regimen of systemic corticosteroids
• Unwilling/unable to receive periodic oral assessments by a study evaluator or unable to complete the daily self-reported outcome questionnaire
• Pregnant or breast-feeding women
• Bronchoalveolar carcinoma
• Metastases to the central nervous system
• Prior or planned focal radiation therapy in the head or neck regions for the treatment of cancer (prior radiation to areas other than the head and neck is permitted)
• Presence of active or history of chronic oral mucosal disease
• Presence or history of any other primary malignancy (curatively treated nonmelanoma skin cancer is allowed)
• History of chronic liver disease
• Active hepatitis A or B
• Unable to receive CT during the OM Treatment CT Cycle at the same regimen and/or dose as in the immediately preceding CT cycle.
• Known sensitivity to tetracyclines
• Known to be seropositive for HIV or HCV
• Use of an immunosuppressive regimen of systemic corticosteroids.
• Current alcohol dependence or drug abuse
• Psychological, social or familial or geographical reasons that would hinder or prevent study visits
• Compromised ability to give written informed consent and/or to comply with study procedures