Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer

Exclusion Criteria

• •1. Gross total excision of the primary and nodal disease.
• •2. Prior treatment with IV or oral rigosertib.
• •3. Prior chemotherapy for the study HNSCC cancer.
• •4. Prior radiotherapy to the region of the study HNSCC cancer or adjacent anatomical sites, or to \> 25% of marrow-bearing area.
• •5. Synchronous malignancies.
• •6. Prior invasive malignancy unless the patient is disease-free for a minimum of 3 years; however, patients with prior non-melanoma skin cancer, cervical intraepithelial neoplasia (CIN), or prostate cancer with undetectable prostate-specific antigen (PSA) may be enrolled.
• •7. Severe, active comorbidity.
• •8. Known infection with human immunodeficiency virus (HIV).
• •9. Any uncontrolled condition that, in the opinion of the Investigator, could affect the subject's participation in the study.
• •10. Major surgery within 3 weeks of enrollment or major surgery without full recovery.
• •11. Ascites requiring active medical management, including paracentesis.
• •12. Hyponatremia (defined as serum sodium \< 130 milliequivalent mEq/L) or conditions that may predispose patients to hyponatremia.
• •13. Uncontrolled hypertension, defined as systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 110 mmHg, despite treatment with 2 antihypertensive agents.
• •14. New onset of seizures within 3 months prior to enrollment, or poorly controlled seizures.
• •15. Female patients who are pregnant or lactating.
• •16. Female patients of childbearing potential and male patients with partners of childbearing potential who are unwilling to follow strict contraception requirements.
• •17. Female patients of childbearing potential who do not have a negative blood or urine pregnancy test at Screening.
• •18. History of allergic reactions attributed to compounds of similar chemical or biologic composition to rigosertib.
• •19. Prior therapy with a phosphatidyl-inositol 3 kinase (PI3K), Akt or mammalian target of rapamycin (mTOR) inhibitor.
• •20. Any other investigational agent or chemotherapy, radiotherapy, or immunotherapy within 4 weeks of enrollment.
• •21. Psychiatric illness/social situations that would limit the patient's ability to tolerate and/or comply with study requirements, or inability to comply with study and/or follow-up procedures.