Phase I : Cediranib in Combination With Lomustine Chemotherapy in Recurrent Malignant Brain Tumour - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00503204

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 I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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:

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Lomustine Cediranib

U.S. FDA Resources

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
Estimated Study Completion Date:	December 2008
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lomustine + Cediranib (AZD2171)	Drug: Cediranib oral tablet Drug: Lomustine oral capsule

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

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

Additional Information:

US and Canada only This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AstraZeneca ( Jane Robertson, Medical Science Director )
Study ID Numbers:	D8480C00057, EuDract 2007-000909-30
Study First Received:	July 16, 2007
Last Updated:	September 3, 2009
ClinicalTrials.gov Identifier:	NCT00503204 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

cancer
tumor
advance solid tumour
glioblastoma
malignant brain tumour

Study placed in the following topic categories:

Glioblastoma
Astrocytoma
Lomustine
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Recurrence
Brain Neoplasms

Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Antineoplastic Agents, Alkylating
Glioma
Alkylating Agents
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Glioblastoma
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Neoplasms, Nerve Tissue
Lomustine
Central Nervous System Neoplasms
Brain Diseases
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Glioma
Alkylating Agents

Nervous System Neoplasms
Neoplasms by Histologic Type
Astrocytoma
Nervous System Diseases
Central Nervous System Diseases
Recurrence
Pharmacologic Actions
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms
Antineoplastic Agents, Alkylating
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009