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Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma (REGAL)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00777153
First received: October 20, 2008
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  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
Drug: Placebo Cediranib
 Phase 3

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
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Baseline at 6 weeks and then every 6 weeks to discontinuation ] [ Designated as safety issue: No ]

    For patients with measurable disease at entry (at least one lesion that has a shortest diameter

    ≥10 mm at baseline on 2 axial slices), PFS will be defined as the earliest time that:

    1. The sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions has increased by a greater than or equal to 25% in comparison to the nadir scan as long as the shortest diameter is ≥15 mm. If the dose of steroids has been reduced within the 10 days prior to the scan being conducted, progression will be based on a follow-up scan performed after the dose of steroids has been stabilized for 10 days.
    2. The patient has died from any cause.
    3. A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm.


Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline through to date of death up to 25th April 2010 ] [ Designated as safety issue: No ]
    Number of months from randomisation to the date of death from any cause

  • Response Rate [ Time Frame: Baseline at 6 weeks and then every 6 weeks to discontinuation ] [ Designated as safety issue: No ]

    An individual visit response of PR was defined as a greater than or equal to 50% reduction in the sum of the products of the largest perpendicular diameters of contrast enhancement for all lesions compared to baseline as long as the steroid dose has not been increased within the previous 10 days and no new lesions are present.

    An individual visit response of CR was defined as the complete disappearance of all tumor on MRI scan.


  • Alive and Progression Free Rate at 6 Months (APF6) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.

  • Daily Steroid Dose [ Time Frame: Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25 ] [ Designated as safety issue: No ]

    % change in mean daily steroid dose from baseline to progression (based on central review or death) or study discontinuation (whichever is earlier).

    If a patient had not progressed or discontinued the study, the data cut-off date was used (2010-04-25).


  • Steroid Free Days [ Time Frame: Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assed up to 2014-April-25 ] [ Designated as safety issue: No ]
    Number of days known not to have used any steroids prior to progression


Enrollment: 325
Study Start Date: October 2008
Estimated Study Completion Date: June 2013
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 and Placebo Cediranib
Lomustine and Placebo Cediranib
 Drug: Lomustine Chemotherapy
110 mg/m2 / Q6W, oral, until progression
Drug: Placebo Cediranib
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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00777153     History of Changes
Other Study ID Numbers: D8480C00055
Study First Received: October 20, 2008
Results First Received: April 3, 2012
Last Updated: March 1, 2013
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 - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
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 May 23, 2013