Endometrial CarcinomaPhase 2NCT00334295

Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.

A Phase 2 study testing Fulvestrant in people with Endometrial Carcinoma, run by AstraZeneca at 9 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Endometrial Carcinoma
What is being tested?: Fulvestrant
Type of treatment: Injection or infusion
How many people: 35 participants
Where: 9 sitesGermany
Study dates: Dec 2002to Jan 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically confirmed, recurrent or metastatic endometrial carcinoma
Postmenopausal
Hormonreceptor positive

Who cannot join

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

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Germany9 sites

Research Site
Erlangen
Research Site
Göttingen
Research Site
Halle
Research Site
Jena
Research Site
Lübeck
Research Site
Mainz
Research Site
Münster
Research Site
Neunkirchen
Research Site
Rostock

Other trials in Germany

About this study

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.

Conditions: Endometrial Carcinoma
Being tested: Fulvestrant
Keywords: Recurrent or metastatic endometrial carcinoma
Medical subject headings: Endometrial Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up to 1 year

Secondary outcomes (4)

Time to Progression of Disease (TTP-Time To Progression, for ITT Set)
median TTP
Measured: 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
median overall survival (OS)
Measured: 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
number of adverse events
Measured: 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)
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).
Measured: ICF (Baseline) up to 12 months (12 visits)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2002Jan 2011

First posted7 Jun 2006 (estimated)
Study startDec 2002
Primary completionJan 2011
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Endometrial CarcinomaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00334295
Sponsor's protocol ID: 9238GR/0002
Status last verified: Jun 2012
First submitted: 5 Jun 2006
Last updated: 31 Jul 2012
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

All Endometrial Carcinoma trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00334295
Acronym / sponsor ID: 9238GR/0002
Conditions: Endometrial Carcinoma
Keywords: Recurrent or metastatic endometrial carcinoma
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2002
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 7 Jun 2006 (estimated)
Results: Posted 31 Jul 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Histologically confirmed, recurrent or metastatic endometrial carcinoma
Postmenopausal
Hormonreceptor positive

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FulvestrantA monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.	Drug	–

Primary outcome

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.

4 secondary outcomes

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)
Determination (for ITT Set): Median Survival
Time frame: 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
Time frame: 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)
Time frame: ICF (Baseline) up to 12 months (12 visits)

Results and safety

Results posted to the registry on 31 Jul 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fulvestrant	35	30

Primary outcome: 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. Unit: participants

Measure	Fulvestrant n = 26
Value	5

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fulvestrant	11 of ?	32 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Endometrial Carcinoma

Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca Germany Medical Director, MD study director

AstraZeneca

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fulvestrant in people with Endometrial Carcinoma, run by AstraZeneca at 9 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334295.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2012.