Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02537223
Recruitment Status : Active, not recruiting
First Posted : September 1, 2015
Last Update Posted : April 19, 2019
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
University Health Network, Toronto

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.


Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of Head and Neck Locoregionally Advanced Drug: BYL719 Drug: Cisplatin Radiation: Intensity modulated radiation therapy (IMRT) Phase 1

Detailed Description:

Participants will be screened for eligibility within 30 days of the intended start of the study treatment. Procedures for research purposes done during screening include archival tumor tissue collection for pharmacodynamic and predictive biomarker research and optional HPV status (if not already known).

Eligible participants will take BYL719, by mouth, once a day, starting one week prior to start of radiation and chemotherapy, for 8 weeks. The starting dose of BYL719 is 200 mg. Participants will be asked to record their doses on a study drug diary. Participants will also receive radiation therapy every day from Monday to Friday for 7 weeks.

Chemotherapy (cisplatin) will be given intravenously on Monday of weeks 1, 4, and 7 (48 hour window during weeks 4 and 7).

While receiving the study treatment, participants will have tests and procedures done once every week for safety purposes.

After the end of the study treatment, participants will be asked to visit the centre every 2 weeks up to week 8 for additional tests and procedures for safety purposes. Between week 8-12 after completing the study treatment, participants will have tumor measurements done to assess efficacy.

Participants will continued to be followed every 3 months up to 1 year, then every 6 months for 2 years (total of 3 years).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Trial of BYL719 in Combination With Concurrent Cisplatin-based Chemoradiotherapy in Patients With Locoregionally Advanced Squamous Cell Carcinoma of Head and Neck (LA-SCCHN)
Study Start Date : September 2015
Actual Primary Completion Date : June 14, 2018
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: BYL719, Cisplatin, and Radiation Therapy
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)



Primary Outcome Measures :
  1. Number of Treatment Emergent Side Effects [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Time from date of enrollment to date of relapse disease [ Time Frame: 3 years ]
  2. Number of patients who do not have locoregional relapse of disease [ Time Frame: 6 months ]
  3. Number of patients who do not have locoregional relapse of disease [ Time Frame: 12 months ]
  4. Number of patients who do not have a distant metastatic relapse of disease [ Time Frame: 6 months ]
  5. Number of patients who do not have a distant metastatic relapse of disease [ Time Frame: 12 months ]
  6. Time from date of enrolment to date of death [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02537223


Locations
Layout table for location information
Canada, Ontario
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M3G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Principal Investigator: Aaron Hansen, M.D. Princess Margaret Cancer Centre
Layout table for additonal information
Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02537223    
Other Study ID Numbers: BCX-001
First Posted: September 1, 2015    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Cisplatin
Antineoplastic Agents