Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel
Study identifier:D0810C00004
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
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
190
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jun 2007
Estimated Primary Completion Date: 01 Dec 2012
Estimated Study Completion Date: 01 Aug 2013
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2012 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Carboplatin + KU-0059436 | Drug: KU-0059436 (AZD2281)(PARP inhibitor) oral Other Name: Olaparib Drug: Carboplatin intravenous injection Other Name: CBDCA Other Name: Paraplatin® |
| Experimental: 2. Paclitaxel + KU-0059436 | Drug: KU-0059436 (AZD2281)(PARP inhibitor) Oral Other Name: Olaparib Drug: Paclitaxel Intravenous injection |
| Experimental: 3. Paclitaxel, Carboplatin + KU-0059436 | Drug: KU-0059436 (AZD2281)(PARP inhibitor) Oral Other Name: Olaparib Drug: Paclitaxel + Carboplatin Intravenous injection |
Contacts
Investigators
Principal Investigator
Jane Robertson
AstraZeneca
