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

AstraZeneca20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Recurrent Glioblastoma Brain Tumor

Interventions

CediranibDRUG

oral tablet

LomustineDRUG

oral capsule

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Boston, Massachusetts, United States

Research Site

Sutton, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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