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

Phase 1

Completed

• Conditions: Recurrent Glioblastoma; Brain Tumor
• Interventions: Drug: Cediranib; Drug: Lomustine

• Registration Number: NCT00503204
• Lead Sponsor: AstraZeneca

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

Not available

Study Timeline

• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-18
• Study Start: 2007-09
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-24
• Last Update Posted: 2009-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Lomustine	Lomustine + Cediranib (AZD2171)
1	Cediranib	Lomustine + Cediranib (AZD2171)

Primary Outcome Measures

Name	Time	Method
Assess the safety and tolerability of cediranib in combination with oral lomustine and to confirm a dose for further studies with this combination.	Assessed at each visit

Secondary Outcome Measures

Name	Time	Method
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	assessed 2 & 4 hours post dosing

Trial Locations

Locations (1)

Research Site; 🇬🇧 Sutton, United Kingdom