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

NCT ID: NCT00515866

Last Updated: 2013-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pancreatic Neoplasms

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Gemcitabine + KU-0059436

Group Type EXPERIMENTAL

KU-0059436 (AZD2281)(PARP inhibitor)

Intervention Type DRUG

oral

Gemcitabine

Intervention Type DRUG

intravenous injection

Interventions

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KU-0059436 (AZD2281)(PARP inhibitor)

oral

Intervention Type DRUG

Gemcitabine

intravenous injection

Intervention Type DRUG

Other Intervention Names

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Olaparib Gemzar® Gemcitabine HCL

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard A Burris III, MD

Role: PRINCIPAL_INVESTIGATOR

The Sarah Cannon Cancer Center

Jane Robertson, BSc, MBCHB, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

New York, New York, United States

Site Status

Research Site

Nashville, Tennessee, United States

Site Status

Research Site

London, , United Kingdom

Site Status

Research Site

Oxford, , United Kingdom

Site Status

Countries

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Germany United States United Kingdom

References

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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.

Reference Type DERIVED
PMID: 25573533 (View on PubMed)

Other Identifiers

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D0810C00005

Identifier Type: -

Identifier Source: secondary_id

KU36-29

Identifier Type: -

Identifier Source: org_study_id