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

Primary Purpose

Pancreatic Neoplasms

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

KU-0059436 (AZD2281)(PARP inhibitor)

Gemcitabine

About this trial

This is an interventional treatment trial for Pancreatic Neoplasms focused on measuring Advanced pancreatic cancer, Poly (ADP ribose) polymerases, Advanced Solid Tumours

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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;

Sites / Locations

Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Gemcitabine + KU-0059436

Outcomes

Primary Outcome Measures

To establish the maximum tolerated dose (MTD) or a tolerable and effective dose of KU 0059436 in combination with gemcitabine

Secondary Outcome Measures

To identify the dose-limiting toxicity of the combination therapy

Full Information

NCT ID

NCT00515866

First Posted

August 13, 2007

Last Updated

December 19, 2013

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00515866

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Neoplasms

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

68 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Gemcitabine + KU-0059436

Intervention Type

Drug

Intervention Name(s)

KU-0059436 (AZD2281)(PARP inhibitor)

Other Intervention Name(s)

Olaparib

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Other Intervention Name(s)

Gemzar®, Gemcitabine HCL

Intervention Description

intravenous injection

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

To identify the dose-limiting toxicity of the combination therapy

Time Frame

assessed at each visit

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Howard A Burris III, MD

Organizational Affiliation

The Sarah Cannon Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jane Robertson, BSc, MBCHB, MD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

New York

State/Province

New York

Country

United States

Facility Name

Research Site

City

Nashville

State/Province

Tennessee

Country

United States

Facility Name

Research Site

City

London

Country

United Kingdom

Facility Name

Research Site

City

Oxford

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

25573533

Citation

Bendell J, O'Reilly EM, Middleton MR, Chau I, Hochster H, Fielding A, Burke W, Burris H 3rd. Phase I study of olaparib plus gemcitabine in patients with advanced solid tumours and comparison with gemcitabine alone in patients with locally advanced/metastatic pancreatic cancer. Ann Oncol. 2015 Apr;26(4):804-811. doi: 10.1093/annonc/mdu581. Epub 2015 Jan 7.

Results Reference

derived

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

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