A Phase Ib/II, Open-label Study of LJM716 in Combination With BYL719 Compared to Taxane or Irinotecan in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase Ib primary outcome measure: Incidence rate of dose limiting toxicities (DLTs).
The open-label dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or Recommended Phase II Dose (s) guided by the safety (incidence of dose limiting toxicities), efficacy, pharmacokinetics and pharmacodynamics data.
approximately 8 months
United States: Food and Drug Administration
|MD Anderson Cancer Center/University of Texas Gastrointestinal Med. Oncology||Houston, Texas 77030-4009|
|University of Chicago Medical Center Dept of Onc||Chicago, Illinois 60546|
|Wayne State University/Karmanos Cancer Institute Dept of Onc||Detroit, Michigan 48201|