Safety and Tolerability Study of AZD7762 in Combination With Gemcitabine

NCT ID: NCT00937664

Last Updated: 2011-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-02-28

Brief Summary

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The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD7762 when given with the approved drug gemcitabine based on the side effects experienced by patients that receive both drugs.

Detailed Description

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Conditions

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Cancer Solid Tumors Advanced Solid Malignancies

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AZD7762 + gemcitabine

AZD7762 administered alone and in combination with gemcitabine

Group Type OTHER

AZD7762

Intervention Type DRUG

solution, intravenous, weekly

gemcitabine

Intervention Type DRUG

intravenous, weekly

Interventions

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AZD7762

solution, intravenous, weekly

Intervention Type DRUG

gemcitabine

intravenous, weekly

Intervention Type DRUG

Other Intervention Names

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Gemzar

Eligibility Criteria

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Inclusion Criteria

* Japanese patients with advanced solid tumors for which standard treatment does not exist or is no longer effective.
* Must be suitable for treatment with gemcitabine
* Relatively good overall health other than cancer

Exclusion Criteria

* Poor bone marrow function (not producing enough blood cells).
* Poor liver or kidney function.
* Serious heart conditions
Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Peter Langmuir, MD

Role: STUDY_DIRECTOR

AstraZeneca

Takashi Seto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Hospital Organization Kyushu Cancer Center

Locations

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Research Site

Minamiku, Fukuoka, Japan

Site Status

Countries

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Japan

Other Identifiers

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D1040C00008

Identifier Type: -

Identifier Source: org_study_id

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