Study To Assess The Safety & Tolerability Of A PARP Inhibitor In Combination With Gemcitabine In Pancreatic Cancer

Study Overview

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

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.

N/A

Pancreatic Neoplasms

DRUG: KU-0059436 (AZD2281)(PARP inhibitor)
DRUG: Gemcitabine

KU36-29
D0810C00005

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-08-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-12-19
First Submitted that Met QC Criteria 2007-08-13	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-12-20
First Posted (ESTIMATED) 2007-08-14	Results First Posted N/A	Last Verified 2013-12

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 1 Gemcitabine + KU-0059436	DRUG: KU-0059436 (AZD2281)(PARP inhibitor) oral DRUG: Gemcitabine intravenous injection

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 1

Gemcitabine + KU-0059436

DRUG: KU-0059436 (AZD2281)(PARP inhibitor)

oral

DRUG: Gemcitabine

intravenous injection

Primary Outcome Measures	Measure Description	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 Outcome Measures	Measure Description	Time Frame
To identify the dose-limiting toxicity of the combination therapy		assessed at each visit

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Howard A Burris III, MD, The Sarah Cannon Cancer Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Learn

Resources

Patients

Caregivers

Clinical Trial Record