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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00503204

Enrollment

Registered

2007-07-18

Start date

2007-09-30

Completion date

2008-12-31

Last updated

2009-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Tumor, Recurrent Glioblastoma

Keywords

cancer, tumor, advance solid tumour, glioblastoma, malignant brain tumour

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.

Interventions

DRUGCediranib

oral tablet

DRUGLomustine

oral capsule

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026