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Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD6918

NCT ID: NCT00733031

Last Updated: 2010-12-10

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

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-03-31

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 AZD6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily AZD6918 alone. It is possible that AZD6918 will be administered twice daily. Then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.

Detailed Description

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Conditions

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Cancer, Solid Tumors Advanced Solid Malignancies

Keywords

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Phase I, cancer, solid tumors, advanced solid malignancies, dose escalation, combination treatment, TRK inhibitor

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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gemcitabine

gemcitabine administered in combination with AZD6918

Group Type EXPERIMENTAL

gemcitabine

Intervention Type DRUG

intravenous, doses are on an intermittent schedule

pemetrexed

pemetrexed administered in combination with AZD6918

Group Type EXPERIMENTAL

pemetrexed

Intervention Type DRUG

intravenous, dose administered every 21-days

AZD6918

AZD6918 administered alone

Group Type EXPERIMENTAL

AZD6918

Intervention Type DRUG

liquid suspension, daily, oral dose

Interventions

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AZD6918

liquid suspension, daily, oral dose

Intervention Type DRUG

gemcitabine

intravenous, doses are on an intermittent schedule

Intervention Type DRUG

pemetrexed

intravenous, dose administered every 21-days

Intervention Type DRUG

Other Intervention Names

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Gemzar Alimta

Eligibility Criteria

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Inclusion Criteria

* Advanced solid tumors for which standard treatment does not exist or is no longer effective.
* For chemotherapy combination treatment, must be suitable for treatment with either gemcitabine or pemetrexed.
* 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
* History of uncontrolled epilepsy, Parkinson's disease, Alzheimer's disease, brain tumor or any uncontrolled psychiatric or nervous system condition
Minimum Eligible Age

18 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 Pharmaceuticals, LP

Principal Investigators

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Judith Ochs, MD

Role: STUDY_DIRECTOR

AstraZeneca

Jeffrey Infante, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Lia Gore, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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Research Site

Aurora, Colorado, United States

Site Status

Research Site

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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D2785C00002

Identifier Type: -

Identifier Source: org_study_id