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Completed

NCT Number: NCT00777153

Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma

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.

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Key information

Conditions

Recurrent Glioblastoma Astrocytoma Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Camperdown, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cediranib

Drug

30 mg/day, oral, until progression

Lomustine Chemotherapy

Drug

110 mg/m2 / Q6W, oral, until progression

Placebo Cediranib

Drug

Oral, until progression

Primary outcomes

  1. 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:

    • 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.
    • The patient has died from any cause.
    • A new lesion is detected that is outside the original tumor volume and has a shortest diameter ≥10 mm.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: REGAL

Important dates

Study start
2008
Primary completion
2010
Study completion
2016
First posted
Oct 22, 2008
Registry last updated
Dec 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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