Study of Efficacy and Safety of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Recurrent or Metastatic Head and Neck Cancer Previously Pre-treated With a Platinum Therapy
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Buparlisib; Buparlisib matching Placebo; Paclitaxel
Intervention description: Buparlisib comes in gelatin capsules and is taken orally at a dose of 100 mg/day.; Buparlisib matching placebo comes in gelatin capsules and is taken orally at a dose of 100 mg/day.; Paclitaxel is an intravenous infusion that is given once every week in 80 mg/m^2.
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 157.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: platinum pre-treated recurrent or metastatic; Head and neck squamous cell carcinoma; recurrent; metastatic; BKM120

Summary:

      Phase II Study of efficacy and safety of buparlisib (BKM120) plus paclitaxel versus placebo
      plus paclitaxel in recurrent or metastatic Head and Neck cancer previously pre-treated with a
      platinum therapy.The primary endpoint was PFS and the key secondary endpoint was Overall
      Survival.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has histologically/cytologically-confirmed HNSCC.

          -  Patient has archival or fresh tumor tissue for the analysis of PI3K-related
             biomarkers. One tumor block (preferred) or a minimum of 12 unstained slides to be
             provided. Enrollment in the study is contingent on confirmation of an adequate amount
             of tumor tissue.

          -  Patients with recurrent or metastatic disease resistant to platinum-based chemotherapy
             (defined as progression while on 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

        Exclusion Criteria:

          -  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);