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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Head and Neck Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT01852292

Run by

Novartis Pharmaceuticals

People needed

157

Starts

2013-10-01

Expected to finish

2017-03-30

Last updated by the study team

2018-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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);

Where it is running

• Dana Farber Cancer Institute IRB — Boston, Massachusetts, United States
• Washington U School of Medicine Center for Clinical Studies SC - BKM120H2201 — St Louis, Missouri, United States
• The Mount Sinai Hospital Dept of Oncology — New York, New York, United States
• University of N.C. at Chapel Hill Lineberger Comp. Cancer Ctr. — Chapel Hill, North Carolina, United States
• University Hospitals Case Medical Center Univ. Hospitals of Cleveland — Cleveland, Ohio, United States
• UPMC Cancer Centers BKM120H2201 — Pittsburgh, Pennsylvania, United States
• Novartis Investigative Site — St Leonards, New South Wales, Australia
• Novartis Investigative Site — Hamilton, Ontario, Canada
• Novartis Investigative Site — Montreal, Quebec, Canada
• Novartis Investigative Site — Saint-Herblain, France
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Hanover, Germany
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Nyíregyháza, Hungary
• Novartis Investigative Site — Nashik, Maharashtra, India
• Novartis Investigative Site — Dehli, New Delhi, India
• Novartis Investigative Site — Jaipur, Rajasthan, India
• Novartis Investigative Site — Kolkata, West Bengal, India
• Novartis Investigative Site — Kerala, India
• Novartis Investigative Site — Mumbai, India
• Novartis Investigative Site — Dublin, Ireland
• Highlands Oncology Group — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

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