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

Tracking Information

First Received Date ^ICMJE

July 16, 2007

Last Updated Date

September 3, 2009

Start Date ^ICMJE

September 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Assess the safety and tolerability of cediranib in combination with oral lomustine and to confirm a dose for further studies with this combination. [ Time Frame: Assessed at each visit ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

assess the safety and tolerability of AZD2171 in combination with oral lomustine and to determine a dose for further studies with this combination

Change History

Complete list of historical versions of study NCT00503204 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Compare the pharmacokinetics of cediranib alone versus when in combination with lomustine as measured by minimum steady state plasma concentration (Css,min) steady-state plasma concentration [ Time Frame: assessed 2 & 4 hours post dosing ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

compare the PK of AZD2171 alone vs when in combination with lomustine as measured by minimum steady state plasma concentration (Css,min)steady state plasma concentration 2&4 hrs post dosing

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase I, Open Label, Multi-Centre Study to Assess the Safety and Tolerability of Cediranib (RECENTIN™, AZD2171) in Combination With Lomustine Chemotherapy for Patients With Primary Recurrent Malignant Brain Tumours for Whom Lomustine Would be a Standard Therapy

Brief Summary

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

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Condition ^ICMJE

Recurrent Glioblastoma
Brain Tumor

Intervention ^ICMJE

Drug: Cediranib
Drug: Lomustine

Study Arms / Comparison Groups

Experimental: Lomustine + Cediranib (AZD2171)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00503204

Responsible Party

Jane Robertson, Medical Science Director, AstraZeneca

Study ID Numbers ^ICMJE

D8480C00057, EuDract 2007-000909-30

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Jane Robertson	AstraZeneca
Principal Investigator:	Tracy Batchelor, MD	Massachusetts General Hospital

Information Provided By

AstraZeneca

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP