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Phase 1/2 Study of GCS-100 in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B Cell Lymphoma
Phase 1/2, open-label, dose-escalation study to assess the safety and tolerability of GCS-100 in combination with etoposide and dexamethasone in patients with 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potentiation of the killing of lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum, unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.)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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
UCLA Medical Center
Los Angeles, California, United States
Start Date
July 1, 2008
Primary Completion Date
April 1, 2009
Completion Date
April 1, 2009
Last Updated
June 25, 2013
GCS-100
DRUG
Etoposide; Dexamethasone
DRUG
Lead Sponsor
La Jolla Pharmaceutical Company
NCT05139017
NCT01804686
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