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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00515866

Enrollment

Registered

2007-08-14

Start date

2007-08-31

Completion date

2012-07-31

Last updated

2013-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Keywords

Advanced pancreatic cancer, Poly (ADP ribose) polymerases, Advanced Solid Tumours

Brief 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.

Interventions

DRUGKU-0059436 (AZD2281)(PARP inhibitor)

oral

DRUGGemcitabine

intravenous injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine	assessed at each visit

Secondary

Measure	Time frame
To identify the dose-limiting toxicity of the combination therapy	assessed at each visit

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026