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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00503204
First Posted: July 18, 2007
Last Update Posted: November 25, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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
Intervention Model: Single Group Assignment
Masking: None (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 ]

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 ]

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:
  • RECENTIN™
  • AZD2171
Drug: Lomustine
oral capsule
Other Names:
  • CCNU
  • CeeNU®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00503204


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

Responsible Party: Jane Robertson, Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00503204     History of Changes
Other Study ID Numbers: D8480C00057
EuDract 2007-000909-30
First Submitted: July 16, 2007
First Posted: July 18, 2007
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by AstraZeneca:
cancer
tumor
advance solid tumour
glioblastoma
malignant brain tumour

Additional relevant MeSH terms:
Glioblastoma
Brain Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cediranib
Lomustine
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents