NCT00421889

A Study of Belinostat + Carboplatin or Paclitaxel or Both in Patients With Ovarian Cancer in Need of Relapse Treatment

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Valerio Therapeutics · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer
• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Bladder Cancer

Interventions

Type	Name	Description
DRUG	belinostat
DRUG	Paclitaxel
DRUG	Carboplatin

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2007-01-15
• Last updated: 2015-07-28
• Results posted: 2014-12-15

Locations

11 sites across 3 countries: United States, Denmark, United Kingdom