Overview

This trial is active, not recruiting.

Condition platinum pre-treated recurrent or metastatic head and neck squamous cell carcinoma.
Treatments paclitaxel, buparlisib, buparlisib placebo
Phase phase 2
Target PI3K
Sponsor Novartis Pharmaceuticals
Start date October 2013
End date March 2017
Trial size 157 participants
Trial identifier NCT01852292, CBKM120H2201

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
buparlisib (BKM120) 100 mg daily + Paclitaxel
paclitaxel This is a combination trial, all patients will be tretaed with paclitaxel +/- buparlisib.
buparlisib BKM120
(Placebo Comparator)
buparlisib matching placebo
paclitaxel This is a combination trial, all patients will be tretaed with paclitaxel +/- buparlisib.
buparlisib placebo

Primary Outcomes

Measure
Progression Free Survival (PFS)
time frame: at 4 weeks after study treatment start

Secondary Outcomes

Measure
Overall Survival
time frame: every 3 months for 2 years
Safety and Tolerability - frequency and severity of adverse events
time frame: on an ongoing basis for a maximum of 2 years.
Overall Response Rate (ORR)
time frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years.
Time to Response (TTR)
time frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years.
Disease Control Rate (DCR)
time frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years.
Duration of Response (DoR)
time frame: at 4 weeks after study treatment start and every 6 weeks afterwards until 2 years.
Change from baseline in the global health status/QOL and pain scale scores of the EORTC QLQ-C30 and QLQ-HN35
time frame: baseline and every 6 weeks after randomization for 2 years .
Time to definitive 10% deterioration in the global health status/QOL (quality of life)
time frame: baseline, and every 6 weeks after randomization for maximum for 2 years
Pain scale scores of the EORTC QLQ-C30 and QLQ-HN35
time frame: baseline, and every 6 weeks after randomization for maximum for 2 years
PK Sampling
time frame: Cycle 1, Day1 of ecah cycle until Cycle 6

Eligibility Criteria

Male or female participants at least 18 years old.

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);

Additional Information

Official title Double Blind, Placebo Controlled Study Assessing the Efficacy of Buparlisib (BKM120) Plus Paclitaxel Versus Placebo Plus Paclitaxel in Patients With Platinum Pre-treated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
Description The primary endpoint is PFS and the key secondary endpoint is Overall Survival.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Novartis.
Location data was received from the National Cancer Institute and was last updated in August 2016.