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

Sponsor:	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:	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:

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
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

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:	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
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012