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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00515866
Recruitment Status : Completed
First Posted : August 14, 2007
Last Update Posted : December 20, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Neoplasms Drug: KU-0059436 (AZD2281)(PARP inhibitor) Drug: Gemcitabine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2007
Actual Primary Completion Date : October 2011
Actual Study Completion Date : July 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Gemcitabine + KU-0059436
 Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Name: Olaparib

Drug: Gemcitabine
intravenous injection
Other Names:
  • Gemzar®
  • Gemcitabine HCL


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. To identify the dose-limiting toxicity of the combination therapy [ Time Frame: assessed at each visit ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00515866


Locations
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United States, New York
Research Site
New York, New York, United States
United States, Tennessee
Research Site
Nashville, Tennessee, United States
United Kingdom
Research Site
London, United Kingdom
Research Site
Oxford, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Howard A Burris III, MD The Sarah Cannon Cancer Center
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00515866    
Other Study ID Numbers: KU36-29
D0810C00005
First Posted: August 14, 2007    Key Record Dates
Last Update Posted: December 20, 2013
Last Verified: December 2013
Keywords provided by AstraZeneca:
Advanced pancreatic cancer
Poly (ADP ribose) polymerases
Advanced Solid Tumours
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs