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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.


Phase 2
18 Years
N/A
Not Enrolling
Female
Endometrial Carcinoma

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Trial Information

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.


Inclusion Criteria:



- Histologically confirmed, recurrent or metastatic endometrial carcinoma

- Postmenopausal

- Hormonreceptor positive

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

up to 1 year

Safety Issue:

No

Principal Investigator

AstraZeneca Germany Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

9238GR/0002

NCT ID:

NCT00334295

Start Date:

December 2002

Completion Date:

January 2011

Related Keywords:

  • Endometrial Carcinoma
  • Recurrent or metastatic endometrial carcinoma
  • Carcinoma
  • Adenoma
  • Endometrial Neoplasms

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