Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cance… (NCT02113878) | Clinical Trial Compass
CompletedPhase 1
Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck
United States23 participantsStarted 2014-09-29
Plain-language summary
This research study is evaluating a drug called buparlisib (BKM120) as a possible treatment for locally advanced head and neck squamous cell cancer.
Who can participate
Age range18 Years
SexALL
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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 i…