NCT00334295

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2006

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

July 31, 2012

Completed
Last Updated

July 31, 2012

Status Verified

June 1, 2012

Enrollment Period

8.1 years

First QC Date

June 5, 2006

Results QC Date

January 11, 2012

Last Update Submit

June 11, 2012

Conditions

Endometrial Carcinoma

Keywords

Recurrent or metastatic endometrial carcinoma

Outcome Measures

Primary Outcomes (1)

  • 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

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

    up to 1 year

Secondary Outcomes (4)

  • Time to Progression of Disease (TTP-Time To Progression, for ITT Set)

    ICF (Informed Consent Form completed) to the date of objective progression or death (by any cause in the absence of progression)

  • Determination (for ITT Set): Median Survival

    ICF to the date of death

  • Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities

    ICF to Last Patient Out (LPO)

  • Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)

    ICF (Baseline) up to 12 months (12 visits)

Interventions

FulvestrantDRUG

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed, recurrent or metastatic endometrial carcinoma
  • Postmenopausal
  • Hormonreceptor positive

You may not qualify if:

  • Pre-treatment with Fulvestrant
  • Previous endocrine therapy of the endometrial carcinoma
  • Previous malignancy less than 3 years ago other than in situ carcinoma of the cervix, basal cell carcinoma or squamous carcinoma of the skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Erlangen, Germany

Location

Research Site

Göttingen, Germany

Location

Research Site

Halle, Germany

Location

Research Site

Jena, Germany

Location

Research Site

Lübeck, Germany

Location

Research Site

Mainz, Germany

Location

Research Site

Münster, Germany

Location

Research Site

Neunkirchen, Germany

Location

Research Site

Rostock, Germany

Location

MeSH Terms

Conditions

Endometrial NeoplasmsRecurrence

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • AstraZeneca Germany Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2006

First Posted

June 7, 2006

Study Start

December 1, 2002

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

July 31, 2012

Results First Posted

July 31, 2012

Record last verified: 2012-06

Locations

DE(9)