Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma (REGAL)
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| ClinicalTrials.gov Identifier: NCT00777153 |
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Recruitment Status :
Completed
First Posted : October 22, 2008
Results First Posted : December 21, 2012
Last Update Posted : December 28, 2016
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Recurrent Glioblastoma | Drug: Cediranib Drug: Lomustine Chemotherapy Drug: Placebo Cediranib | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 423 participants |
| 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 |
| Study Start Date : | October 2008 |
| Actual Primary Completion Date : | April 2010 |
| Actual Study Completion Date : | September 2016 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Lomustine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Cediranib 30mg
Cediranib 30mg
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Drug: Cediranib
30 mg/day, oral, until progression |
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Cediranib 20mg + lomustine
Cediranib 20mg + lomustine
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Drug: Cediranib
20 mg/day, oral, until progression Drug: Lomustine Chemotherapy 110 mg/m2 / Q6W, oral, until progression |
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Active Comparator: Lomustine and Placebo Cediranib
Lomustine and Placebo Cediranib
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Drug: Lomustine Chemotherapy
110 mg/m2 / Q6W, oral, until progression Drug: Placebo Cediranib Oral, until progression |
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:
- 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 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
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| 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
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
Locations
Show 62 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Jane Robertson | AstraZeneca | |
| Principal Investigator: | Tracy Batchelor, MD, MPH | Massachusetts General Hospital |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00777153 |
| Other Study ID Numbers: |
D8480C00055 |
| First Posted: | October 22, 2008 Key Record Dates |
| Results First Posted: | December 21, 2012 |
| Last Update Posted: | December 28, 2016 |
| Last Verified: | October 2016 |
Keywords provided by AstraZeneca:
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Cancer Tumour Advanced Solid Tumour GBM Glioblastoma |
Additional relevant MeSH terms:
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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 |