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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: July 16, 2007
Last updated: November 24, 2009
Last verified: November 2009
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.

Condition Intervention Phase
Recurrent Glioblastoma
Brain Tumor
Drug: Cediranib
Drug: Lomustine
Phase 1

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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lomustine + Cediranib (AZD2171)
Drug: Cediranib
oral tablet
Other Names:
  • AZD2171
Drug: Lomustine
oral capsule
Other Names:
  • CCNU
  • CeeNU®


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00503204

United States, Massachusetts
Research Site
Boston, Massachusetts, United States
United Kingdom
Research Site
Sutton, United Kingdom
Sponsors and Collaborators
Study Director: Jane Robertson AstraZeneca
Principal Investigator: Tracy Batchelor, MD Massachusetts General Hospital
  More Information

Additional Information:
Responsible Party: Jane Robertson, Medical Science Director, AstraZeneca Identifier: NCT00503204     History of Changes
Other Study ID Numbers: D8480C00057  EuDract 2007-000909-30 
Study First Received: July 16, 2007
Last Updated: November 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
advance solid tumour
malignant brain tumour

Additional relevant MeSH terms:
Brain Neoplasms
Brain Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Nervous System Diseases
Nervous System Neoplasms
Neuroectodermal Tumors
Alkylating Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses processed this record on April 27, 2016