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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00515866
First received: August 13, 2007
Last updated: December 14, 2012
Last verified: December 2012
History of Changes
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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 ]

Enrollment: 68
Study Start Date: August 2007
Study Completion Date: July 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Gemcitabine + KU-0059436
 Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Name: Olaparib
Drug: Gemcitabine
intravenous injection
Other Names:
  • Gemzar®
  • Gemcitabine HCL

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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
Investigators
Principal Investigator: Howard A Burris III, MD The Sarah Cannon Cancer Center
Study Director: Jane Robertson, BSc, MBCHB, MD AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00515866     History of Changes
Other Study ID Numbers: D0810C00005, KU36-29
Study First Received: August 13, 2007
Last Updated: December 14, 2012
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:
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 19, 2013