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

This study is ongoing, but not recruiting participants.

First Received: August 13, 2007 Last Updated: March 11, 2010 History of Changes

Sponsor:	AstraZeneca
Collaborator:	KuDOS Pharmaceuticals Limited
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00515866

Purpose

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.

Phase II dose has now been determined and the study is now assessing this dose in a Phase II like randomised expansion

Condition	Intervention	Phase
Pancreatic Neoplasms	Drug: KU-0059436 (AZD2281)(PARP inhibitor) Drug: Gemcitabine	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine Gemcitabine hydrochloride AZD 2281

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To identify the dose-limiting toxicity of the combination therapy [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	95
Study Start Date:	August 2007
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Gemcitabine + KU-0059436	Drug: KU-0059436 (AZD2281)(PARP inhibitor) oral Drug: Gemcitabine intravenous injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Expansion 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00515866

Locations

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

KuDOS Pharmaceuticals Limited

Investigators

Principal Investigator:

Howard A Burris III, MD

The Sarah Cannon Cancer Center

More Information

Additional Information:

Cancer Study Locator (US and Canada only) This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	D0810C00005, KU36-29
Study First Received:	August 13, 2007
Last Updated:	March 11, 2010
ClinicalTrials.gov Identifier:	NCT00515866 History of Changes
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

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

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Digestive System Neoplasms
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Enzyme Inhibitors

Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Radiation-Sensitizing Agents
Therapeutic Uses
Pancreatic Diseases
Gemcitabine
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on March 16, 2010