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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 determine whether doses of 30 mg and 45 mg AZD2171 can be well tolerated without significant drug withdrawal when accompanied by a suitable hypertension management strategy or dose reduction.

Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients with Advanced Solid Tumours

AstraZeneca Information - Outside of the US

Research Site

A Phase II, Randomised, Factorial, Double-blind Study to Investigate the management of AZD2171-induced Hypertension and Efficacy of AZD2171 at Doses of 30 mg and 45 mg in Patients with Advanced Solid Tumours

Total actual dose received during the first 12 weeks prior to progression divided by the planned dose (planned dose: initial allocated dose multiplied by the number of days on study during the first 12 weeks prior to progression)

Age Continuous

Gender, Male/Female

Proportion of patients requiring temporary (>1 day) or permanent withdrawal of AZD2171 prior to progression and within 12 weeks of first dose of AZD2171

Proportion of planned dose received during first 12 weeks of therapy with AZD2171

Proportion of patients requiring temporary (>1 day) or permanent withdrawal of AZD2171 prior to progression and within 6 weeks of first dose of AZD2171

Number of patients with complete or partial response (CR/PR), based on RECIST

Objective response rate

Maximum percentage reduction or minimum percentage increase in tumour size where size is the sum of the longest diameters of the target lesions. Based on the baseline scaled ratio: ratio of the post-randomisation visit tumour size divided by the baseline tumour size.

Arms	Assigned Interventions
Experimental: 1 30 mg AZD2171	Drug: AZD2171 30 mg & 45 mg oral tablet Other Name: Cediranib Other Name: RECENTIN™
Experimental: 2 45 mg AZD2171	Drug: AZD2171 30 mg & 45 mg oral tablet Other Name: Cediranib Other Name: RECENTIN™

Study to Investigate the Management of Hypertension and Efficacy of AZD2171 in Patients with Advanced Solid Tumours

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

AstraZeneca Information - Outside of the US

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=420&filename=CSR-D8480C00038.pdf

CSR-D8480C00038.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator