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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00777153
First Posted: October 22, 2008
Last Update Posted: December 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


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 ]

    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 ]
    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 ]

    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 ]
    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 ]
    The mean steroid dosage prior to treatment will be considered as the patient's baseline. The percent change in average daily steroid dosage from baseline is calculated by following formula: PC = (md - bm)/bm*100; where PC is the percent change in average daily steroid dosage from baseline; md the mean daily steroid dosage recorded from the first day of therapy to progression; and bm the baseline mean.

  • Steroid Free Days [ Time Frame: Baseline to the date of first documented progression or date of death or study discontinuation, whichever came first, assessed up to 2014-April-25 ]
    Number of days known not to have used any steroids prior to progression


Enrollment: 423
Study Start Date: October 2008
Study Completion Date: September 2016
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00777153


  Show 62 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00777153     History of Changes
Other Study ID Numbers: D8480C00055
First Submitted: October 20, 2008
First Posted: October 22, 2008
Results First Submitted: April 3, 2012
Results First Posted: December 21, 2012
Last Update Posted: December 28, 2016
Last Verified: October 2016

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
Cediranib
Lomustine
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents