NCT00873119

Belinostat, Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Cancer of Unknown Primary

An Open-label Randomized Phase II Trial of Belinostat (PXD101) in Combination With Carboplatin and Paclitaxel (BelCaP) Compared to Carboplatin and Paclitaxel in Patients With Previously Untreated Carcinoma of Unknown Primary

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Valerio Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess efficacy and safety of belinostat in combination with carboplatin and paclitaxel in patients with previously untreated carcinoma of unknown primary.

Detailed description

This is an open-label, multinational, multicenter, randomized, comparative efficacy and safety study in previously untreated patients with carcinoma of unknown primary. Patients meeting inclusion and exclusion criteria will be randomized to treatment in Arm A (BelCaP) or Arm B (CaP).

Conditions

• Carcinoma of Unknown Primary

Interventions

Type	Name	Description
DRUG	belinostat, carboplatin, paclitaxel
DRUG	carboplatin, paclitaxel

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-04-01
• Last updated: 2015-07-28
• Results posted: 2014-12-09

Locations

23 sites across 4 countries: United States, Denmark, France, Germany