Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma - Full Text View

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Lomustine Cediranib

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Assessment of progression free survival (PFS). [ Time Frame: MRI taken at baseline and thereafter every 6 weeks until progression ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of overall survival [ 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 overall response rate [ 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 APF6 [ 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 daily steroid dose [ 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 steroid-free days [ 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 ]

Enrollment:	325
Study Start Date:	October 2008
Estimated Study Completion Date:	June 2012
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cediranib 30mg Cediranib 30mg	Drug: Cediranib 30 mg/day, oral, until progression
Cediranib 20mg + lomustine Cediranib 20mg + lomustine	Drug: Cediranib 20 mg/day, oral, until progression Drug: Lomustine Chemotherapy 110 mg/m2 / Q6W, oral, until progression
Active Comparator: Lomustine Lomustine	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 3 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

Show 78 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:

Cancer Study Locator (US and Canada only) This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Jane Robertson, Medical Science Director (RECENTIN), AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00777153 History of Changes
Other Study ID Numbers:	D8480C00055
Study First Received:	October 20, 2008
Last Updated:	June 13, 2011
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

Additional relevant MeSH terms:

Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
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