Trial Outcomes & Findings for Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma. (NCT NCT00334295)

NCT ID: NCT00334295

Last Updated: 2012-07-31

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: up to 1 year
• Results posted on: 2012-07-31

Participant Flow

Participant milestones

Measure	Fulvestrant A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Overall Study STARTED	35
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Fulvestrant A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Overall Study Patients received fewer than 3 injection	5

Baseline Characteristics

Fulvestrant for the Treatment of Recurrent or Metastatic Endometrial Carcinoma.

Baseline characteristics by cohort

Measure	Fulvestrant n=35 Participants A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Age, Customized	69.5 years n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Fulvestrant n=26 Participants 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	5 participants

SECONDARY outcome

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

median TTP

Outcome measures

Measure	Fulvestrant n=26 Participants A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Time to Progression of Disease (TTP-Time To Progression, for ITT Set)	3.1 months Interval 2.6 to 6.5

SECONDARY outcome

Timeframe: ICF to the date of death

median overall survival (OS)

Outcome measures

Measure	Fulvestrant n=26 Participants 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 Set): Median Survival	16.7 months Interval 8.6 to 44.4

SECONDARY outcome

Timeframe: ICF to Last Patient Out (LPO)

number of adverse events

Outcome measures

Measure	Fulvestrant n=35 Participants A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Determination (All Subjects Treated (AST) Set): Safety and Toxicity by Assessment of the Frequency of Grade I-IV Haematological and Non-haematological Toxicities	169 adverse events

SECONDARY outcome

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

Population: FACT-En was evaluated descriptively for change from baseline of the total score using the AST population, presented for the first 12 visits. Due to death or other patients individual reasons only 4 participants were motivated to complete the FACT-En questionnaire form.

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).

Outcome measures

Measure	Fulvestrant n=4 Participants A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Evaluation (Patient-reported): Change From Baseline in Health-related Quality of Life (HR-QoL) at 12 Months (12 Visits)	6.0 units on a scale 95% Confidence Interval 1.3- • Interval -1.3 to 13.3

Adverse Events

Fulvestrant

Serious events: 11 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fulvestrant A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Cardiac disorders Tachycardia	2.9% 1/35
Gastrointestinal disorders Ileus	5.7% 2/35
Gastrointestinal disorders Abdominal pain	2.9% 1/35
Gastrointestinal disorders Vomiting	2.9% 1/35
Gastrointestinal disorders Subileus	2.9% 1/35
General disorders General physical health deterioration	2.9% 1/35
General disorders Oedema peripheral	2.9% 1/35
Infections and infestations Gastroenteritis	2.9% 1/35
Infections and infestations Wound infection	2.9% 1/35
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 1/35
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	2.9% 1/35
Nervous system disorders Paresis	2.9% 1/35
Psychiatric disorders Depression	2.9% 1/35
Renal and urinary disorders Renal failure	2.9% 1/35
Respiratory, thoracic and mediastinal disorders Dyspnoe	2.9% 1/35
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.9% 1/35
Respiratory, thoracic and mediastinal disorders Aspiration	2.9% 1/35
Vascular disorders Hypertension	2.9% 1/35
Vascular disorders Pulmonary embolism	2.9% 1/35
Vascular disorders Vaginal haemorrhage	2.9% 1/35
Vascular disorders Deep vein thrombosis	2.9% 1/35

Other adverse events

Measure	Fulvestrant A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
Musculoskeletal and connective tissue disorders Arthralgia	8.6% 3/35
Gastrointestinal disorders Abdominal pain	11.4% 4/35
Metabolism and nutrition disorders Anorexia	5.7% 2/35
Gastrointestinal disorders Ascites	8.6% 3/35
General disorders Asthenia	5.7% 2/35
Musculoskeletal and connective tissue disorders Back pain	5.7% 2/35
Musculoskeletal and connective tissue disorders Bone pain	8.6% 3/35
Gastrointestinal disorders Constipation	11.4% 4/35
Respiratory, thoracic and mediastinal disorders Cough	5.7% 2/35
Gastrointestinal disorders Diarrhoea	11.4% 4/35
Respiratory, thoracic and mediastinal disorders Dyspnoea	17.1% 6/35
Skin and subcutaneous tissue disorders Erythema	5.7% 2/35
General disorders Fatigue	22.9% 8/35
Gastrointestinal disorders Flatulence	5.7% 2/35
Nervous system disorders Headache	5.7% 2/35
Vascular disorders Hot flush	17.1% 6/35
Psychiatric disorders Insomnia	5.7% 2/35
Vascular disorders Lymphoedema	5.7% 2/35
Infections and infestations Nasopharyngitis	5.7% 2/35
Gastrointestinal disorders Nausea	25.7% 9/35
General disorders Oedema peripheral	8.6% 3/35
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 2/35
Injury, poisoning and procedural complications Procedural site reaction	5.7% 2/35
Infections and infestations Urinary tract infection	20.0% 7/35
Reproductive system and breast disorders Vaginal haemorrhage	11.4% 4/35
Ear and labyrinth disorders Vertigo	5.7% 2/35
Gastrointestinal disorders Vomiting	11.4% 4/35

Additional Information

Gerard Lynch

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place