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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

This study is to examine the effects on tumors of AZD2171, in the treatment of NSCLC or HNC. The safety and tolerability of AZD2171 will also be studied.

The Effects of AZD2171 in patients with Non-Small Cell Lung Cancer or Head & Neck Cancer

AstraZeneca Information - Outside of the US

Research Site

An Exploratory, Open-Lael study to assess the effects of AZD2171 on tumors and biomarkers in patients with previously untreated or recurrent non-small cell lung cancer (NSCLC) or patients with metastatic or recurrent head and neck cancer (HNC)

Percentage change from baseline in FDG-PET tumour SUVmax at Day 22 ((Day 22 - baseline)/baseline)*100

Age Continuous

Gender, Male/Female

Percentage Change from baseline in Standardised Uptake Value (SUVmax) at Day 22, as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET) Response ((Day 22 SUVmax value – baseline SUVmax value)/baseline SUVmax value)*100

Of the 19 patients, only 17 patients were evaluable for FDG-PET analysis.  To be evaluable for FDG-PET, patients had to have FDG-PET data collected at Day 1 and at least one post-baseline visit.

Change from baseline in Standardised Uptake Value (SUVmax) as Measured by 2-[F-18]-fluoro-2-deoxy-D-glucose positron emission tomography (FDG-PET)

Change from baseline in mean arterial blood pressure (MAP) (MAP value at Day 22 – MAP value at baseline).

Of the 19 patients, only 17 patients were evaluable MAP analysis.  To be evaluable for MAP analysis, patients had to have MAP data collected at Day 1 and at least one post-baseline visit.

Change from baseline in mean arterial blood pressure (MAP)

Overall Study

Gerard Lynch

Change from baseline in MAP at Day 22 (Day 22 - baseline)

The Effects of AZD2171 in patients with Non-Small Cell Lung Cancer or Head & Neck Cancer

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

US and Canada only

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=624&filename=CSR-D8480C00015.pdf

CSR-D8480C00015.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator