CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 80 enrolled
Drug / intervention
belinostat +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00421889
NCT00421889Phase 2Completed
CompareCT.gov

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

Valerio Therapeutics·interventional·Posted Jan 15, 2007·Updated Jul 28, 2015

In Brief

A Phase 2 clinical trial evaluating belinostat, Paclitaxel, and 1 other intervention for Ovarian Cancer and 3 related conditions. Completed, enrolled 80 participants across 11 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer, Epithelial Ovarian Cancer, Fallopian Tube Cancer, Bladder Cancer
CountriesDenmark, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 15, 2007
Enrollment StartAug 1, 2005
Primary CompletionFeb 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 19.5 years ago

Interventions

belinostatdrug

Paclitaxeldrug

Carboplatindrug