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.
- Conditions
- recurrent or metastatic head and neck cancer squamous cell carcinomaMedDRA version: 19.0Level: 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-IE
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 150
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: to estimate the efficacy of buparlisib in combination with paclitaxel;Secondary Objective: To assess the safety and tolerability of buparlisib in combination with paclitaxel in this patient population<br>To evaluate additional efficacy parameters<br>To assess the effect of buparlisib in combination with paclitaxel on patient's symptoms and health-related qualoty of life (HRQoL)<br>To characterize the pharmacokinetics of buparlisib BKM120 given in combination with paclitaxel;Primary end point(s): Progression Free Survival (PFS);Timepoint(s) of evaluation of this end point: at 4 weeks after study treatment start and every 6 weeks afterwards
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1: Overall Survival <br>2: Safety and Tolerability <br>3: Overall Response Rate (ORR)<br>4: Time to Response (TTR) <br>5: Disease Control Rate (DCR)<br>6: Duration of Response (DoR)<br>7 : PK parameters including Cmax, AUCtau<br>8: Change from baseline in the global health status/QOL and pain scale scores of the EORTC QLQ-C30 and QLQ-HN35 <br>9: Time to definitive 10% deterioration in the global health status/QOL (quality of life)<br>10: Pain scale scores of the EORTC QLQ-C30 and QLQ-HN35;Timepoint(s) of evaluation of this end point: For endpoint 1: every 3 months for 2 years <br>For endpoint 2: on an ongoing basis for a maximum of 2 years<br>For endpoints 3, 4, 5 & 6: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years<br>For endpoint 7 : depending on full PK and sparse PK (fore details see protocol)<br>For endpoints 8, 9 & 10: baseline and every 6 weeks after randomization for 2 years