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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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.

Cediranib in Combination with Lomustine Chemotherapy in Recurrent Glioblastoma

Cancer Study Locator (US and Canada only)

Research Site

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

Age Continuous

Gender, Male/Female

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.

Progression free survival (PFS)

Number of months from randomisation to the date of death from any cause

Overall survival (OS)

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.

Patients are only included in the analysis if they have measurable disease at baseline based on central.

Response rate

Proportion of patients alive and progression free at 6 months (based on central review) as estimated from Kaplan-Meier techniques. Values are percentages.

Alive and progression free rate at 6 months (APF6)

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.

Daily steroid dose

Number of days known not to have used any steroids prior to progression

Steroid free days

Overall Study

Randomised=Full Analysis Set (ITT): Cediranib 30 mg=131, Cediranib 20 mg + Lomustine=129, Placebo + Lomustine=65; ITT with measurable disease at baseline (based on site review): Cediranib 30 mg=115, Cediranib 20 mg + Lomustine=112, Placebo + Lomustine=55; Safety Set: Cediranib 30 mg=128, Cediranib 20 mg + Lomustine=123, Placebo + Lomustine=64

Arms	Assigned Interventions
Experimental: Cediranib 30mg Cediranib 30mg	Drug: Cediranib 30 mg/day, oral, until progression
Other: 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

Cediranib in Combination with Lomustine Chemotherapy in Recurrent Glioblastoma - REGAL

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Cancer Study Locator (US and Canada only)

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=425&filename=CSR-D8480C00055.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator