Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck

Exclusion Criteria

• •Distant metastatic disease
• •Less than or equal to 10 pack years of tobacco history
• •Received prior chemotherapy
• •Received prior radiation to the head and neck or adjacent anatomical site
• •Received prior treatment with a P13K inhibitor.
• •Known hypersensitivity to BKM120 or to its excipients
• •Acute or chronic liver, renal disease or pancreatitis
• •Mood disorders ≥ CTCAE grade 3
• •Diarrhea ≥ CTCAE grade 2
• •Active cardiac disease
• •History of cardiac dysfunction including any of the following:
• •Patient has poorly
• •Impairment of gastrointestinal (GI) function
• •Currently receiving treatment with medication with a known risk to prolong the QT interval or inducing Torsades de Pointes and the treatment cannot either be discontinued or switched to a different medication prior to starting study drug.
• •Chronic treatment with steroids or another immunosuppressive agent.
• •Herbal medications and certain fruits within 7 days prior to starting study drug.
• •Currently treated with drugs known to be moderate and strong inhibitors or inducers of isoenzyme CYP3A, and the treatment cannot be discontinued or switched to a different medication prior to starting study drug. Please refer to Appendix B for a list of prohibited inhibitors and inducers of CYP3A (Please note that co-treatment with weak inhibitors of CYP3A is allowed).
• •Undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
• •Currently taking therapeutic doses of warfarin sodium or any other coumadin-derivative anticoagulant.
• •Women who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control.
• •Known diagnosis of human immunodeficiency virus (HIV) infection
• •History of another malignancy within 3 years, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix