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

Study identifier:KU36-96

ClinicalTrials.gov identifier:NCT00516724

EudraCT identifier:2007-000939-26

CTIS identifier:N/A

Recruitment Complete

Official Title

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

Medical condition

Triple Negative Metastatic Breast cancer

Phase

Phase 1

Healthy volunteers

No

Study drug

KU-0059436 (AZD2281)(PARP inhibitor), Carboplatin, Paclitaxel, Paclitaxel + Carboplatin

Sex

All

Actual Enrollment

189

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 22 Jun 2007
Primary Completion Date: 04 Jan 2013
Estimated Study Completion Date: 31 Dec 2024

Study design

Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria