- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00515866
Study to Assess the Safety & Tolerability of a PARP Inhibitor in Combination With Gemcitabine in Pancreatic Cancer
December 19, 2013 updated by: AstraZeneca
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
- Research Site
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Oxford, United Kingdom
- Research Site
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New York
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New York, New York, United States
- Research Site
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Tennessee
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Nashville, Tennessee, United States
- Research Site
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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.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Gemcitabine + KU-0059436
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oral
Other Names:
intravenous injection
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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assessed at each visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To identify the dose-limiting toxicity of the combination therapy
Time Frame: assessed at each visit
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assessed at each visit
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jane Robertson, BSc, MBCHB, MD, AstraZeneca
- Principal Investigator: Howard A Burris III, MD, The Sarah Cannon Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
August 13, 2007
First Submitted That Met QC Criteria
August 13, 2007
First Posted (Estimate)
August 14, 2007
Study Record Updates
Last Update Posted (Estimate)
December 20, 2013
Last Update Submitted That Met QC Criteria
December 19, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Endocrine System Diseases
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Pancreatic Diseases
- Pancreatic Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
- Olaparib
- Poly(ADP-ribose) Polymerase Inhibitors
Other Study ID Numbers
- KU36-29
- D0810C00005
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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