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
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
For Phase Ib: Incidence of Dose Limiting Toxicities (DLTs) in Cycle 1 (Cycle 1=28 days)
Estimation of Maximum Tolerated Doses (MTDs) and/or recommended Phase II doses (RP2Ds) of BYL719 in combination with cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma (RM HNSCC) in arm A (BYL719 administered as a whole tablet in patients able to swallow the tablets) and arm B (BYL719 administered as a drinkable suspension in patients with swallowing dysfunction)
approximately 6 months
Yes
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Australia: Therapeutic Goods Administration (TGA)
CBYL719X2104
NCT01602315
November 2012
February 2015
Name | Location |
---|---|
Massachusetts General Hospital Mass General 2 | Boston, Massachusetts 02114 |
University of Chicago Medical Center University of Chicago (16) | Chicago, Illinois 60546 |
University of California San Francisco UCSF 3 | San Francisco, California 94101 |
Emory University School of Medicine/Winship Cancer Institute Dept of Oncology | Atlanta, Georgia 30322 |
Mount Sinai School of Medicine SC | New York, New York 10029 |
Memorial Sloan Kettering Cancer Center MSKCC NY | New York, New York 10021 |
Vanderbilt University Medical Center Vanderbilt 2 | Nashville, Tennessee 37232 |
MD Anderson Cancer Center/University of Texas Univ TX MD Anderson 2 | Houston, Texas 77030-4009 |