Phase I Study of BYL719 in Combination With Cisplatin and Radiotherapy in Patients With Squamous Cell Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT02537223|
Recruitment Status : Active, not recruiting
First Posted : September 1, 2015
Last Update Posted : April 19, 2019
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|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
Radiation: Intensity modulated radiation therapy (IMRT)
- Number of Treatment Emergent Side Effects [ Time Frame: 3 years ]
- Time from date of enrollment to date of relapse disease [ Time Frame: 3 years ]
- Number of patients who do not have locoregional relapse of disease [ Time Frame: 6 months ]
- Number of patients who do not have locoregional relapse of disease [ Time Frame: 12 months ]
- Number of patients who do not have a distant metastatic relapse of disease [ Time Frame: 6 months ]
- Number of patients who do not have a distant metastatic relapse of disease [ Time Frame: 12 months ]
- Time from date of enrolment to date of death [ Time Frame: 3 years ]
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
|Princess Margaret Cancer Centre|
|Toronto, Ontario, Canada, M3G 2M9|
|Principal Investigator:||Aaron Hansen, M.D.||Princess Margaret Cancer Centre|