Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.
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|ClinicalTrials.gov Identifier: NCT00334295|
Recruitment Status : Completed
First Posted : June 7, 2006
Results First Posted : July 31, 2012
Last Update Posted : July 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Endometrial Carcinoma||Drug: Fulvestrant||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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.|
|Study Start Date :||December 2002|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
- Drug: Fulvestrant
A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
- 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 Frame: up to 1 year ]Number of patients with Complete Remission (CR) and Partial Response (PR), as determined by an independent expert panel according to the WHO response criteria.
- Time to Progression of Disease (TTP-Time To Progression, for ITT Set) [ Time Frame: ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression) ]median TTP
- Determination (for ITT Set): Median Survival [ Time Frame: ICF to the date of death ]median overall survival (OS)
- Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities [ Time Frame: ICF to Last Patient Out (LPO) ]number of adverse events
- Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits) [ Time Frame: ICF (Baseline) up to 12 months (12 visits) ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334295
|Study Director:||AstraZeneca Germany Medical Director, MD||AstraZeneca|