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

• Status: Active, not recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment for locally advanced head and neck squamous cell cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Novartis Pharmaceuticals
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Stage III/IV, locally advanced, biopsy proven squamous cell cancer of the head and neck that undergo chemoradiation as their primary treatment with curative intent.

• Oropharynx (HPV positive and HPV negative), hypopharynx, larynx primaries, nasopharynx as well as those with documented SCC of the cervical lymph nodes, with unknown primaries.

• >10 pack years of tobacco use

• Age ≥ 18 years

• ECOG performance status ≤ 2

• At least one site of measurable disease

• Adequate bone marrow function as shown by: ANC > 1.5 x 109/L, Platelets >100 x 109/L, Hb >9 g/dL

• Total calcium (corrected for serum albumin) within normal limits

• Magnesium ≥ the lower limit of normal

• Potassium within normal limits for the institution.

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within normal range

• Serum bilirubin within normal range (or ≤ 1.5 x ULN if liver metastases are present; or total bilirubin ≤ 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert Syndrome)

• Serum creatinine ≤ 1.5 x ULN or 24-hour clearance ≥ 50 mL/min

• Serum amylase ≤ ULN

• Serum lipase ≤ ULN

• Fasting plasma glucose ≤ 120 mg/dL (6.7 mmol/L)

• Signed informed consent

• INR ≤ 2

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