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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 the efficacy of a monthly administration of Fulvestrant in patients with recurrent or metastatic endometrial carcinoma by assessment of the clinical tumour response after 3 injections.

Fulvestrant for the treatment of recurrent or metastatic endometrial carcinoma.

A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.

Research Site

An open, non-randomised multicentre phase II study to assess the efficacy and tolerability of a 250 mg monthly dose of i.m. applied Fulvestrant for the treatment of recurrent or metastatic endometrial carcinoma.

Number of patients with Complete Remission (CR) and  Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.

Age, Customized

Gender, Male/Female

Determination (for ITT (Intet-to-Treat set): Efficacy of a monthly administration of Fulvestrant in patients with recurrent or metastatic endometrial carcinoma by assessment of the clinical tumour response after 3 injections of Fulvestrant

Time to progression of disease (TTP-Time To Progression, for ITT set)

Determination (for ITT set): Median survival

Determination (All Subjects Treated (AST) set): Safety and toxicity by assessment of the frequency of grade I-IV haematological and non-haematological toxicities

Patient-reported FACT-EN questionaire. Presented is the change from baseline after 12 visits/12 months. The overall total score of 43 single items was transformed to a scale from 0  to 100 (0 = worst level of well-being; 100 = highest level of well-being).

FACT-En was evaluated descriptively for change from baseline of the total score using the AST population, presented for the first 12 visits. Due to death or other patients individual reasons only 4 participants were motivated to complete the FACT-En questionnaire form.

Fulvestrant for the treatment of recurrent or metastatic endometrial carcinoma.

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=225&filename=CSR-9238GR-0002.pdf

CSR-9238GR-0002.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator