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NCT00515866 Clinical Trial

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

Pancreatic Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00515866
Other study ID # KU36-29
Secondary ID D0810C00005
Status Completed
Phase Phase 1
First received August 13, 2007
Last updated December 19, 2013
Start date August 2007
Est. completion date July 2012

Study information
Verified date December 2013
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationGermany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date July 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• KU-0059436 (AZD2281)(PARP inhibitor)
oral
• Gemcitabine
intravenous injection

Locations
Country Name City State
United Kingdom Research Site London
United Kingdom Research Site Oxford
United States Research Site Nashville Tennessee
United States Research Site New York New York

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine assessed at each visit No
Secondary To identify the dose-limiting toxicity of the combination therapy assessed at each visit No
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Completed NCT00385177 - Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid Tumors Phase 1
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