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Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour

NCT ID: NCT00503204

Last Updated: 2009-11-25

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-12-31

Brief Summary

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This is a Phase I, open-label, multi-centre study designed to assess the safety and tolerability of Cediranib in combination with lomustine in patients with primary recurrent malignant brain tumour.

Detailed Description

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Conditions

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Recurrent Glioblastoma Brain Tumor

Keywords

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cancer tumor advance solid tumour glioblastoma malignant brain tumour

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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1

Lomustine + Cediranib (AZD2171)

Group Type EXPERIMENTAL

Cediranib

Intervention Type DRUG

oral tablet

Lomustine

Intervention Type DRUG

oral capsule

Interventions

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Cediranib

oral tablet

Intervention Type DRUG

Lomustine

oral capsule

Intervention Type DRUG

Other Intervention Names

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RECENTIN™ AZD2171 CCNU CeeNU®

Eligibility Criteria

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Inclusion Criteria

* Primary recurrent malignant brain tumour for whom lomustine would be standard therapy - diagnosis \& stage
* Patients received no more than 2 previous systemic chemotherapy regimes
* Life Expectancy \> 12 weeks
* Patients must be at least 3 months from the completion of cranial radiation therapy

Exclusion Criteria

* History of poorly controlled high blood pressure
* Recent major surgery prior to entry into the study
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

Principal Investigators

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Jane Robertson

Role: STUDY_DIRECTOR

AstraZeneca

Tracy Batchelor, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Research Site

Boston, Massachusetts, United States

Site Status

Research Site

Sutton, , United Kingdom

Site Status

Countries

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United States United Kingdom

Other Identifiers

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EuDract 2007-000909-30

Identifier Type: -

Identifier Source: secondary_id

D8480C00057

Identifier Type: -

Identifier Source: org_study_id