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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Recurrent Glioblastoma; Brain Tumor

Treatments: Drug: Lomustine; Drug: Cediranib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00503204

D8480C00057

EuDract 2007-000909-30

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Experimental group

Description:

Lomustine + Cediranib (AZD2171)

Treatment:

Drug: Lomustine

Drug: Cediranib