Phase I Study of BYL719 in Combination With Cisplatin and Radiotherapy in Patients With Squamous Cell Head and Neck Cancer

• Status: Completed
• Trial end date: 2020-02-20
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 1 study (the first step in testing a new drug or combination, to see how safe the drug and/or combination are) of investigational agent BYL719 in patients with locally advanced head and neck cancer (LA-SCCHN) in combination with standard radiation and chemotherapy (cisplatin).

BYL719 is a new drug that is able to bind (attach to) and block a protein called PI3K-alpha. PI3K-alpha is part of an important pathway called EGFR/PI3K/Akt. A pathway is a series of chemical reactions among proteins in the cells that are involved in the support of normal cellular function. If the pathway is too active, due to changes in those proteins, the pathway can lead to tumor cell growth, survival and invasion. BYL719 has been shown to stop cancers in laboratory and animal studies.

This study is the first time BYL719 will be combined with radiation and chemotherapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Novartis Pharmaceuticals
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Willing and able to comply with study requirements

• Age >= 18 years

• Life expectancy >6 months

• Previously untreated locally advanced squamous cell carcinoma of the head and neck eligible for cisplatin-based chemoradiation

• Not have received prior anti-neoplastic treatment within 2 years

• Resolved toxicities to Grade 1 or less

• Performance status of 0-1

• Adequate organ function

• Able to swallow and retain oral medication

Exclusion Criteria:

• Enrolled on another intervention clinical trial or in prior study within 30 days.

• Taking drugs with risk of prolonging the QT interval or of causing Torsades de Pointes

• Any condition that could increase the risk to the patient by participating which may include:

• Lung disease or uncontrolled hypertension

• Cardiovascular/vascular/cardiac disease

• Uncontrolled severe infection

• Impaired lung function

• Chronic treatment with corticosteroids/immunosuppressive agents

• Not recovered from previous toxicities

• Systemic therapy within 4 weeks of the start of the study treatment

• Active bacterial, fungal or viral infection

• Significant bleeding disorders

• Uncontrolled medical disorder or active infection

• Dementia or significantly altered mental status

• Diabetes mellitus requiring insulin treatment

• Another malignancy within 2 years of the start of the study treatment

• Received live attenuated vaccines within 1 week of the start of the study treatment

• Receiving treatment with drugs known to be moderate or strong inhibitors or inducers of isoenzymes CYP34A or CYP2C8

• Have impaired gastrointestinal (GI) function or GI disease