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

Study identifier:D8480C00057

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

Recurrent Glioblastoma

Phase

Phase 1

Healthy volunteers

Study drug

Cediranib, Lomustine

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Sept 2007

Primary Completion Date: 01 Dec 2008

Study Completion Date: 01 Dec 2008

Study design

Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Sutton, United Kingdom

Location

Research Site

Boston, MA, United States

Arms	Assigned Interventions
Experimental: 1 Lomustine + Cediranib (AZD2171)	Drug: Cediranib oral tablet Other Name: RECENTIN™ Other Name: AZD2171 Drug: Lomustine oral capsule Other Name: CCNU Other Name: CeeNU®

Documents available

US and Canada only
Download
https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=632&filename=CSR-D8480C00057.pdf
Download
CSR-D8480C00057.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Cancer Study Locator Service

877-400-4656

astrazeneca@emergingmed.com

Contact Backup

AstraZeneca Information (outside US)

001-866-992-9276

EnquiriesMailbox.AZD2171Trials@target.azemw.net

Investigators

Principal Investigator

Jane Robertson

AstraZeneca

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

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Documents available

US and Canada only

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=632&filename=CSR-D8480C00057.pdf

CSR-D8480C00057.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator