Phase II multicenter randomized, double blind, placebo controlled study assessing the efficacy of buparlisib (BKM120) plus paclitaxel vs. placebo plus paclitaxel in patients with platinum pre-treated recurrent or metastatic head and neck squamous cell carcinoma.

ovartis Pharma Services AG0 sites150 target enrollmentStarted: September 3, 2015Last updated: May 22, 2017

Conditions

Drugs

Trial Snapshot

No summary available.

•Patient has histologically/cytologically-confirmed HNSCC.
•Patient has archival or fresh new tumor tissue for the analysis of PI3K-related biomarkers. One tumor block (preferred) or a minimum of 15 12 (15 recommended) unstained slides to be provided. Enrollment in the study is contingent on confirmation the central laboratory confirming receipt of an adequate amount of tumor tissue.
•Patients with recurrent or metastatic disease resistant to platinum-based chemotherapy (defined as progression while on or after a platinum-based chemotherapy given in the recurrent/metastatic setting). Pretreatment with cetuximab is allowed
•Measurable disease as determined by per RECIST criteria v1.1. If the only site of measurable disease is a previously irradiated lesion, documented progression of disease and a 4 week period since radiotherapy completion is required
•Adequate bone marrow function and organ function
•ECOG Performance Status = 1
•see protocol for other criteria
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patient has received previous treatment with any AKT, mTOR inhibitors or PI3K pathway inhibitors;
•Patient treated with more than one prior chemotherapy regimen for recurrent/metastatic disease
•Patient has symptomatic CNS metastases. Patients with asymptomatic CNS metastases may participate in this trial. The patient must have completed any prior local treatment for CNS metastases = 28 days prior to the start of study treatment (including radiotherapy and/or surgery) and must have stable low dose of corticosteroid therapy;
•Patient has not recovered to = grade 1 (except alopecia) from related side effects of any prior antineoplastic therapy
•Patient has any of the following cardiac abnormalities:symptomatic congestive heart failure, history of documented congestive heart failure (New York Heart Association functional classification III-IV), documented cardiomyopathy, Left Ventricular Ejection Fraction (LVEF) <50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO); myocardial infarction = 6 months prior to enrolment, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, symptomatic pericarditis, QTcF > 480 msec on the screening ECG (using the QTcF formula);
•see protocol for other criteria

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