NCT00516724

Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel

A Phase I, Open-Label Study to Assess the Safety and Tolerability of KU-0059436 in Combination With Carboplatin, KU-0059436 in Combination With a Paclitaxel/Carboplatin T/C Doublet and KU-0059436 in Combination With Paclitaxel in the Treatment of Patients With Advanced Solid Tumours

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with carboplatin and/or Paclitaxel chemotherapy.

Conditions

• Triple Negative Metastatic Breast Cancer
• Advanced Ovarian Cancer
• Carboplatin
• Paclitaxel

Interventions

Type	Name	Description
DRUG	KU-0059436 (AZD2281)(PARP inhibitor)	oral
DRUG	Carboplatin	intravenous injection
DRUG	KU-0059436 (AZD2281)(PARP inhibitor)	Oral
DRUG	Paclitaxel	Intravenous injection
DRUG	KU-0059436 (AZD2281)(PARP inhibitor)	Oral
DRUG	Paclitaxel + Carboplatin	Intravenous injection

Timeline

• Start date: 2007-06-22
• Primary completion: 2013-01-04
• Completion: 2024-04-11
• First posted: 2007-08-15
• Last updated: 2025-04-11

Locations

4 sites across 3 countries: Belgium, Netherlands, United Kingdom