A phase Ib dose escalation/randomized phase II, multicenter, open-label study of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma
ID Number 13-1530Principal Investigator(s)
Krzysztof J Misiukiewicz
Department(s) or Division(s)
Hematology and Medical Oncology
This study is divided into two parts: The purpose of the first part (phase Ib) of this study is to establish a safe dose range for BYL719 and cetuximab in combination, based on side effects. Once the right dose combination is found, the second part of the study will start. You will participate in the second part of this study (phase II).The goal of the phase II portion of the study is to determine whether BYL719 together with cetuximab delays tumor growth, as compared to
Some patients will receive cetuximab together with BYL719, while others will receive cetuximab alone. By comparing patients who received cetuximab with BYL719 to patients who received cetuximab alone, we will know whether BYL719 is providing any additional benefit. BYL719 is an experimental drug and is not approved by the United States Food and Drug Administration (FDA) for use except in research studies. Cetuximab is a medicine which has been approved by FDA and is available for the treatment of people with your or similar medical condition.
Studies in cells (performed in a laboratory) and animals have shown that the combination of the two drugs can result in a better and more efficient reduction of tumor growth and have less of a chance of becoming resistant to the medicines (that means not responding to medicine
This study will also help to assess what your body does to clear BYL719 from your system
(this is called pharmacokinetics). We will measure blood levels of BYL719 in these samples
to know how much BYL719 is left in your body at different times after you take a BYL719
pill. For this reason, a number of PK blood samples will be collected throughout this study.
In addition, this study will examine the effect of the study drugs are having on your cancer to
try to understand why some patients’ tumors are responding better than others. This effect will
be measured through ‘biomarker’ studies included in this trial. Biomarkers are important
biological “indicators” which can be measured from blood and tumor tissues collected before
and/or during treatment with BYL719 and cetuximab combination or with cetuximab alone.
Recruiting Patients: Yes