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

Brain Tumor Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00503204
• Other study ID #: D8480C00057
• Secondary ID: EuDract 2007-000
• Status: Completed
• Phase: Phase 1
• First received: July 16, 2007
• Last updated: November 24, 2009
• Start date: September 2007
• Est. completion date: December 2008

Study information

• Verified date: November 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Glioblastoma
• Recurrent Glioblastoma

Intervention

Drug:
• Cediranib
oral tablet
• Lomustine
oral capsule

Locations

Country	Name	City	State
United Kingdom	Research Site	Sutton
United States	Research Site	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No

External Links

•   US and Canada only