A Phase I/II Safety, Pharmacodynamic, and Pharmacokinetic Study of Intravenously Administered PXD101 Plus Carboplatin or Paclitaxel or Both in Patients With Advanced Solid Tumours
MTD Expansion I(Phase II): A total of 18-32 patients with epithelial ovarian, primary
peritoneal, fallopian tube or mixed mullerian tumours of ovarian origin, in need of relapse
treatment will be enrolled.
MTD Expansion II (phase II): A total of 15 patients with urothelial (transitional cell)
carcinoma of the bladder will be enrolled.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose and dose limiting toxicities of belinostat (PXD101) administered in combination with standard doses of carboplatin or paclitaxel or both.
throughout the study
United States: Food and Drug Administration
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Greater Baltimore Medical Center||Baltimore, Maryland 21204|
|Gynecologic Oncology Associates||Newport Beach, California 92663|
|Hematology and Oncology Specialists, LLC||New Orleans, Louisiana 70115|
|Research Facility||Orlando, Florida 32804|
|Hematology & Oncology Specialists, LLC||Metairie, Louisiana 70006|
|Women & Infants Hospital of Rhode Island||Providence, Rhode Island 02905|