Phase 1/2 Study of GCS-100 in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B Cell Lymphoma
This study will investigate the safety and efficacy of the combination of GCS-100 with
etoposide and dexamethasone. In vitro data demonstrates potentiation of the killing of
lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum,
unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.) GCS-100
will be administered in increasing doses to define a maximum tolerated dose (MTD) in
combination with these chemotherapeutic agents. When the MTD is defined, the cohort will be
expanded to characterize the efficacy of this combination.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose of GCS-100 in combination with etoposide and dexamethasone by comprehensive lab, pharmacokinetics, physical assessments, and PET-CT imaging.
Study Day 12 for toxicity, and 21-day cycles assessed every 2 cycles by physical and imaging assessments until disease progression
Lauren Pinter-Brown, MD
UCLA, Division of Hematology/Oncology
United States: Food and Drug Administration
|UCLA Medical Center||Los Angeles, California 90095-7059|