NCT00515866

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2007

Longer than P75 for phase_1

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2007

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

December 20, 2013

Status Verified

December 1, 2013

Enrollment Period

4.2 years

First QC Date

August 13, 2007

Last Update Submit

December 19, 2013

Conditions

Pancreatic Neoplasms

Keywords

Advanced pancreatic cancerPoly (ADP ribose) polymerasesAdvanced Solid Tumours

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • To identify the dose-limiting toxicity of the combination therapy

    assessed at each visit

Study Arms (1)

1

EXPERIMENTAL

Gemcitabine + KU-0059436

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

Interventions

KU-0059436 (AZD2281)(PARP inhibitor)DRUG

oral

Also known as: Olaparib
1
GemcitabineDRUG

intravenous injection

Also known as: Gemzar®, Gemcitabine HCL
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed adenocarcinoma of pancreas
  • Locally advanced or metastatic unresectable disease

You may not qualify if:

  • No prior anti cancer chemotherapy, radiotherapy (except palliative \>4 weeks prior to entry, endocrine or immunotherapy or use of other investigational agents;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

New York, New York, United States

Location

Research Site

Nashville, Tennessee, United States

Location

Research Site

London, United Kingdom

Location

Research Site

Oxford, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 25573533DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

olaparibGemcitabine

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Howard A Burris III, MD

    The Sarah Cannon Cancer Center

    PRINCIPAL INVESTIGATOR

  • Jane Robertson, BSc, MBCHB, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2007

First Posted

August 14, 2007

Study Start

August 1, 2007

Primary Completion

October 1, 2011

Study Completion

July 1, 2012

Last Updated

December 20, 2013

Record last verified: 2013-12

Locations

GB(2)US(2)