Phase III: Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma. - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00777153

Purpose

The purpose of this study is to see how effective cediranib is in treating a brain tumour called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an approved oral chemotherapy that belongs to the class of drugs called alkylating agents. Cediranib is a new drug that has not yet been approved for this disease. This study will compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo ("inactive substance") to see whether the combination or cediranib alone will be more effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.

Condition	Intervention	Phase
Recurrent Glioblastoma	Drug: Cediranib Drug: Lomustine Chemotherapy	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Lomustine Cediranib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
Official Title:	A Phase III, Randomised, Parallel Group, Multi-Centre Study in Recurrent Glioblastoma Patients to Compare the Efficacy of Cediranib [RECENTIN™, AZD2171] Monotherapy and the Combination of Cediranib With Lomustine to the Efficacy of Lomustine Alone

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Assess efficacy of cediranib (either in monotherapy or in combination with oral lomustine ) compared to oral lomustine alone by assessment of progression free survival (PFS). [ Time Frame: MRI taken at baseline and thereafeter every 6 weeks until progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of overall survival and overall response rate, APF6 and steroid sparing effects of cediranib (either in monotherapy or in combination with oral lomustine) compared to oral lomustine alone [ Time Frame: Prior to first administration of investigational product (IP). After intake of IP, assessments taken every week for first 6 weeks, then every 3 weeks through study end ] [ Designated as safety issue: No ]
Assessment of safety, tolerability and Quality of life of cediranib (either in monotherapy or in combination with oral lomustine) compared to oral lomustine alone [ Time Frame: Prior to first administration of investigational product (IP). After intake of IP, assessments taken every week for first 6 weeks, then every 3 weeks through study end ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment Group A: Experimental Experimental	Drug: Cediranib 30 mg/day, oral, until progression
Treatment Group B Experimental plus active comparator	Drug: Cediranib 20 mg/day, oral, until progression Drug: Lomustine Chemotherapy 110 mg/m2 / Q6W, oral, until progression
Treatment Group C: Active Comparator Active comparator plus placebo	Drug: Lomustine Chemotherapy 110 mg/m2 / Q6W, oral, until progression

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmation of recurrent glioblastoma
Life expectancy ≥ 12 weeks
Received only one prior systemic chemotherapy regimen and this regimen must contain temozolomide

Exclusion Criteria:

Patients on enzyme-inducing anti-epileptic drugs within 2 weeks prior to randomisation
Poorly controlled hypertension
Previous anti-angiogenesis (eg bevacizumab, sorafenib, sunitinib) therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00777153

Contacts

Contact: AstraZeneca Cancer Study Locator Service	877-400-4656	astrazeneca@emergingmed.com
Contact: AZD2171 Clinical Trials Enquiries		EnquiriesMailbox.AZD2171Trials@target.azemw.net

Show 82 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Jane Robertson	AstraZeneca
Principal Investigator:	Tracy Batchelor, MD, MPH	Massachusetts General Hospital

More Information

Additional Information:

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

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Jane Robertson, Medical Science Director (RECENTIN) )
Study ID Numbers:	D8480C00055
Study First Received:	October 20, 2008
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00777153 History of Changes
Health Authority:	United States: Food and Drug Administration; Austria: Agency for Health and Food Safety; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Federal Agency for Medicinal Products and Health Products; Canada: Health Canada; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; Germany: Federal Ministry of Food, Agriculture and Consumer Protection; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Cancer ; Tumour ; Advanced Solid Tumour ; GBM ; Glioblastoma

Study placed in the following topic categories:

Neuroectodermal Tumors
Glioblastoma
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Lomustine
Neuroepithelioma

Antineoplastic Agents, Alkylating
Glioma
Alkylating Agents
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Glioblastoma
Disease Attributes
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Astrocytoma
Antineoplastic Agents
Lomustine
Neoplasms, Nerve Tissue
Pharmacologic Actions
Recurrence

Neuroectodermal Tumors
Neoplasms
Pathologic Processes
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Antineoplastic Agents, Alkylating
Glioma
Neoplasms, Neuroepithelial
Alkylating Agents
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 06, 2009