Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Completed NCT02113878

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

Conditions: Carcinoma, Squamous Cell of Head and Neck, HPV Positive Oropharyngeal Squamous Cell Carcinoma, Hypopharyngeal Cancer, Early Invasive Cervical Squamous Cell Carcinoma, Carcinoma of Larynx, Cancer of Nasopharynx

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 23
Sponsor: Dana-Farber Cancer Institute

Location: Dana-Farber Cancer Institute Boston Massachusetts

Summary

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

Eligibility 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02113878). StuddyBuddy aggregates publicly available trial information.