Conditions: Ovarian Cancer Epithelial Ovarian Cancer Fallopian Tube Cancer Bladder Cancer
Keywords: Ovarian cancer Ovarian Neoplasms Primary peritoneal Epithelial ovarian Fallopian tube Bladder cancer belinostat PXD101 mixed mullerian cancer of ovarian origin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 80
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Belinostat: 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: Administered IV 2-3 hours after belinostat infusion on day 3 in a 21-day cycle

Carboplatin: Administered IV infusion after paclitaxel on day 3 in a 21-day cycle

Interventions: intervention 1: belinostat intervention 2: Paclitaxel intervention 3: Carboplatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: