A Phase 2 Study of PXD101 in Platinum Resistant Epithelial Ovarian Tumors and Micropapillary/Borderline (LMP) Ovarian Tumors
I. To determine the antitumor activity of PXD 101 as a single agent in the following patient
population using objective response rates (complete and partial): a) Platinum resistant
ovarian carcinoma (progression within 6 months of platinum based therapy); b) Micropapillary
/ borderline (Low Malignant potential) ovarian carcinoma.
I. To determine the antitumor activity of PXD 101 with regards to stable disease rates,
duration of response, progression- free, median and overall survival rates as well as
determine the safety and tolerability this drug.
I. To determine the relationship between clinical and pharmacodynamic effects of PXD101 in
patients with platinum resistant and micropapillary tumors undergoing treatment with this
OUTLINE: This is a multicenter study. Patients are stratified according to diagnosis
(micropapillary or borderline ovarian tumor vs platinum-resistant ovarian epithelial,
primary peritoneal, or fallopian tube cancer).
Patients receive belinostat intravenously (IV) over 30 minutes on days 1-5. Courses repeat
every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of belinostat in terms of complete or partial response; disappearance of all target lesions or at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) or Rustin criteria.
Up to 5 years
Princess Margaret Hospital Phase 2 Consortium
United States: Food and Drug Administration