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

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ClinicalTrials.gov Identifier: NCT00503204
Recruitment Status : Completed
First Posted : July 18, 2007
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief 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.

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma Brain Tumor Drug: Cediranib Drug: Lomustine Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : September 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors
Drug Information available for: Lomustine

Arm Intervention/treatment
Experimental: 1
Lomustine + Cediranib (AZD2171)
Drug: Cediranib
oral tablet
Other Names:
  • RECENTIN™
  • AZD2171

Drug: Lomustine
oral capsule
Other Names:
  • CCNU
  • CeeNU®




Primary Outcome Measures :
  1. 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 :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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 Posted: July 18, 2007    Key Record Dates
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