clinical research study to find out if buparlisib (BKM120) in combination with paclitaxel therapy is safe and has beneficial effects in people who have advances or metastatic head and neck squamous cell carcinoma and were previously treated with platinum-based chemotherapy.

Phase 1

• Conditions: recurrent or metastatic head and neck cancer squamous cell carcinoma; MedDRA version: 16.0Level: PTClassification code 10067821Term: Head and neck cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000744-26-ES
• Lead Sponsor: ovartis Farmacéutica, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-30
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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 15 unstained slides to be provided. Enrollment in the study is contingent on the central laboratory confirming receipt of an adequate amount of 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
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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

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);

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified