CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Fulvestrantdrug
Likely dose
Fulvestrant 250 mg intramuscularly monthlyAI-extracted
Key inclusion· 3
  • ✓Histologically confirmed recurrent or metastatic endometrial carcinoma
  • ✓Postmenopausal status
  • ✓Hormone receptor-positive disease
Key exclusion· 3
  • ✕Prior fulvestrant treatment
  • ✕Previous endocrine therapy for endometrial carcinoma
  • ✕Prior malignancy within 3 years (except cervical in situ carcinoma, basal cell carcinoma, or skin squamous cell carcinoma)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00334295
NCT00334295Phase 2Completed
CompareCT.gov

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.

AstraZeneca·interventional·Posted Jun 7, 2006·Updated Jul 31, 2012

In Brief

A Phase 2 clinical trial evaluating Fulvestrant for Endometrial Carcinoma. Completed, enrolled 35 participants across 9 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEndometrial Carcinoma
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 7, 2006
Enrollment StartDec 1, 2002
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 20.1 years ago

Interventions

Fulvestrantdrug

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