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CompletedNCT00515866Updated Dec 20, 2013

Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer

A Phase 1 interventional study of KU-0059436 (AZD2281)(PARP inhibitor) and Gemcitabine in Pancreatic Neoplasms, sponsored by AstraZeneca. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-20.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 gemcitabine chemotherapy for the treatment of pancreatic cancer.

02

Conditions studied

  • Pancreatic Neoplasms

Keywords

  • Advanced pancreatic cancer
  • Poly (ADP ribose) polymerases
  • Advanced Solid Tumours
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's enrollment of 68 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically or cytologically confirmed adenocarcinoma of pancreas
  • Locally advanced or metastatic unresectable disease

Exclusion criteria

Exclusion Criteria:

  • No prior anti cancer chemotherapy, radiotherapy (except palliative >4 weeks prior to entry, endocrine or immunotherapy or use of other investigational agents;
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Experimental
    1

    Gemcitabine + KU-0059436

    Drug: KU-0059436 (AZD2281)(PARP inhibitor) · Drug: Gemcitabine

Interventions

  • DrugKU-0059436 (AZD2281)(PARP inhibitor)

    oral

    Also known as: Olaparib

  • DrugGemcitabine

    intravenous injection

    Also known as: Gemzar®, Gemcitabine HCL

06

What researchers measure

Primary outcomes

  1. To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine

    Time frame: assessed at each visit

Secondary outcomes

  1. To identify the dose-limiting toxicity of the combination therapy

    Time frame: assessed at each visit

07

Study locations

4 sites
  • Research Site
    New York, New York, United States
  • Research Site
    Nashville, Tennessee, United States
  • Research Site
    London, United Kingdom
  • Research Site
    Oxford, United Kingdom
08

References and documents

Publications

  • Bendell J, O'Reilly EM, Middleton MR, Chau I, Hochster H, Fielding A, Burke W, Burris H 3rd. Phase I study of olaparib plus gemcitabine in patients with advanced solid tumours and comparison with gemcitabine alone in patients with locally advanced/metastatic pancreatic cancer. Ann Oncol. 2015 Apr;26(4):804-811. doi: 10.1093/annonc/mdu581. Epub 2015 Jan 7. PubMed 25573533 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00515866
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Aug 14, 2007
Start date
Aug 2007
Primary completion
Oct 2011
Completion
Jul 2012
Last update
Dec 20, 2013

Study contacts

Howard A Burris III, MD
principal investigator · The Sarah Cannon Cancer Center
Jane Robertson, BSc, MBCHB, MD
study director · AstraZeneca

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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