Ovarian Cancer Clinical Trial
Official title:
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
The study seeks to assess the safety, pharmacodynamics, pharmacokinetics and efficacy of
belinostat (PXD101) administered in combination with carboplatin or paclitaxel or both in
patients with solid tumours followed by maximum tolerated dose (MTD) expansion (phase II) in
ovarian and bladder cancer patients
The clinical trial is now in the MTD (phase II) portion of the study enrolling bladder
cancer patients. Enrollment of ovarian patients is complete.
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
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