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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00515866

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Aug 1, 2007

Actual Primary Completion Date :

Oct 1, 2011

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Gemcitabine + KU-0059436	Drug: KU-0059436 (AZD2281)(PARP inhibitor) oral Other Names: Olaparib Drug: Gemcitabine intravenous injection Other Names: Gemzar® Gemcitabine HCL

Arm

Intervention/Treatment

Experimental: 1

Gemcitabine + KU-0059436

Drug: KU-0059436 (AZD2281)(PARP inhibitor)

oral

Other Names:

Olaparib

Drug: Gemcitabine

intravenous injection

Other Names:

Gemzar®

Gemcitabine HCL

Outcome Measures

Primary Outcome Measures

To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine [assessed at each visit]

Secondary Outcome Measures

To identify the dose-limiting toxicity of the combination therapy [assessed at each visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Research Site	New York	New York	United States
2	Research Site	Nashville	Tennessee	United States
3	Research Site	London		United Kingdom
4	Research Site	Oxford		United Kingdom