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

Novartis

Status and phase: Terminated; Phase 2

Conditions: Head and Neck Squamous Cell Carcinoma

Treatments: Drug: Paclitaxel; Drug: Buparlisib; Drug: Buparlisib matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01852292

2013-000744-26 (EudraCT Number)

CBKM120H2201

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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157 participants in 2 patient groups, including a placebo group

Buparlisib + weekly Paclitaxel

Experimental group

Description:

Patients who were randomized to this arm on a 1:1 randomization, took buparlisib 100 mg daily and paclitaxel 80 mg/m\^2 weekly.

Treatment:

Drug: Paclitaxel

Drug: Buparlisib

Buparlisib matching placebo + Paclitaxel

Placebo Comparator group

Description:

Patients who were randomized to this arm on a 1:1 randomization, took buparlisib matching placebo 100 mg daily and paclitaxel 80 mg/m\^2 weekly.

Treatment:

Drug: Buparlisib matching Placebo

Drug: Paclitaxel