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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00503204
First received: July 16, 2007
Last updated: November 24, 2009
Last verified: November 2009
  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
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:
  • RECENTIN™
  • AZD2171
Drug: Lomustine
oral capsule
Other Names:
  • CCNU
  • CeeNU®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jane Robertson, Medical Science Director, AstraZeneca
ClinicalTrials.gov 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:
cancer
tumor
advance solid tumour
glioblastoma
malignant brain tumour

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

ClinicalTrials.gov processed this record on August 20, 2014