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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 evaluate the overall objective tumor response rate (ORR) of Gefitinib.

First-line treatment for adenocarcinoma patients with Epidermal Growth Factor Receptor (EGFR) mutation

Research Site

An open-label, Multi-centre study to evaluate efficacy and safety of Gefitinib as the first-line treatment for locally advanced (IIIB), metastatic (IV) or recurrent pulmonary adenocarcinoma patients with Epidermal Growth Factor Receptor (EGFR) mutation.

Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.
RECIST criteria: 
CR = disappearance of all target lesions
PR = 30% decrease in the sum of the longest diameter of target lesions
PD = 20% increase in the sum of the longest diameter of target lesions
SD (stable disease) = small changes that do not meet above criteria

AgeContinuous

Gender, Male/Female

Percentage of participants who had an Objective Response Rate(ORR) based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.

Progression free survival calculated using Kaplan-Meier Product Limit.  Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period.  Therefore, PFS percentage at 4 months is provided.

Progression free survival (PFS)

Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period.  Therefore, OS percentage at 12 months is provided.

Overall survival (OS)

Safety profile as defined by adverse events and serious adverse events throughtout the study period.  Details listed in the SAE and Other AE section.

First-line treatment for adenocarcinoma patients with Epidermal Growth Factor Receptor (EGFR) mutation

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

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=410&filename=CSR-D7913L00056.pdf

CSR-D7913L00056.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator