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

NCT02537223 | Completed Phase 1

• 1 other identifier: BCX-001
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Squamous Cell Carcinoma of Head and Neck; Locoregionally Advanced

Outcome Measures

Primary Outcomes (1)

• Number of Treatment Emergent Side Effects

  3 years

Secondary Outcomes (6)

• Time from date of enrollment to date of relapse disease

  3 years

• Number of patients who do not have locoregional relapse of disease

  6 months

• Number of patients who do not have locoregional relapse of disease

  12 months

• Number of patients who do not have a distant metastatic relapse of disease

  6 months

• Number of patients who do not have a distant metastatic relapse of disease

  12 months

Study Arms (1)

BYL719, Cisplatin, and Radiation Therapy

EXPERIMENTAL

BYL719, orally, at a starting dose of 200-350 mg, once daily, for 7 weeks. Cisplatin, intravenously, at 100 mg/m2 over 1 hour, every 3 weeks for 3 doses. Radiation therapy, Monday to Friday, for 7 weeks.

Drug: BYL719; Drug: Cisplatin; Radiation: Intensity modulated radiation therapy (IMRT)

Interventions

BYL719 DRUG

BYL719, Cisplatin, and Radiation Therapy

Cisplatin DRUG

BYL719, Cisplatin, and Radiation Therapy

Intensity modulated radiation therapy (IMRT) RADIATION

BYL719, Cisplatin, and Radiation Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M3G 2M9, Canada

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Alpelisib; Cisplatin; Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Aaron Hansen, M.D.

  Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2015
• First Posted: September 1, 2015
• Study Start: September 1, 2015
• Primary Completion: June 14, 2018
• Study Completion: February 20, 2020
• Last Updated: April 19, 2021

Record last verified: 2021-04

Locations

CA (1)