Study to assess the safety & tolerability of a PARP inhibitor in combination with gemcitabine in pancreatic cancer
Study identifier:D0810C00005
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 in Combination with Gemcitabine in the Treatment of Patients With Advanced Solid Tumours
Medical condition
Pancreatic neoplasms
Phase
Phase 1
Healthy volunteers
No
Study drug
KU-0059436 (AZD2281)(PARP inhibitor), Gemcitabine
Sex
All
Actual Enrollment
68
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Aug 2007
Primary Completion Date: 01 Oct 2011
Study Completion Date: 01 Jul 2012
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Gemcitabine + KU-0059436 | Drug: KU-0059436 (AZD2281)(PARP inhibitor) oral Other Name: Olaparib Drug: Gemcitabine intravenous injection Other Name: Gemzar® Other Name: Gemcitabine HCL |
Contacts
Investigators
Principal Investigator
Howard A Burris III
The Sarah Cannon Cancer Center
