Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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8 January 2018 |
Main ID: |
EUCTR2014-003220-52-DE |
Date of registration:
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22/04/2015 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A clinical trial to see if the combination CC-486 plus fulvestrant is effective and safe, compared to fulvestrant alone, in patients with metastatic breast cancer that is estrogen receptor-positive and human epidermal growth factor receptor 2-negative
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Scientific title:
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A Phase 2, Randomized, Open-Label, Two-arm Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with ER+, HER2- Metastatic Breast Cancer Who Have Progressed on an Aromatase Inhibitor |
Date of first enrolment:
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26/10/2015 |
Target sample size:
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92 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-003220-52 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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France
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Germany
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Italy
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Spain
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United States
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Contacts
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Name:
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ClinicalTrialDisclosure
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Address:
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9225 Indian Creek Parkway, Suite 900
66210
Overland Park, Kansas
United States |
Telephone:
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+18882601599 |
Email:
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ClinicalTrialDisclosure@celgene.com |
Affiliation:
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Celgene Corporation |
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Name:
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ClinicalTrialDisclosure
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Address:
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9225 Indian Creek Parkway, Suite 900
66210
Overland Park, Kansas
United States |
Telephone:
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+18882601599 |
Email:
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ClinicalTrialDisclosure@celgene.com |
Affiliation:
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Celgene Corporation |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Subject is female =18 years of age (at the time of signing the informed consent form) with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy.
-Subject is considered postmenopausal
-Subject has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer by local laboratory (based on most recently analyzed biopsy).
-Subject has human epidermal growth factor receptor 2 negative (HER2-) breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an Immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
-Subject had disease refractory to an AI
-Subject has an Eastern Cooperative Oncology Group ( ECOG) performance status of 0-1.
- Subject has radiological documented measurable disease (ie, at least one measureable lesion as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1).
•If no measurable disease is present, then at least one predominantly lytic bone lesion must be present
-Subject has adequate organ function.
-Subject has adequate bone marrow function. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria: -Subject has received > 1 prior line of chemotherapy in the metastatic setting
-Subject has received any chemotherapy within 21 days prior to randomization.
-Subject has received prior treatment with fulvestrant.
-Subject has been previously treated with azacitidine (any formulation), decitabine, or any other hypomethylating agent.
-Subject has a history of, or current symptomatic brain metastasis.
-Subject has severe renal impairment (creatinine clearance < 30 ml/min).
- Subject has an impaired ability to swallow oral medication.
-Subject has a contraindication to receiving IM injections (eg, bleeding disorders, anticoagulant use).
-Subject has significant active cardiac disease within the previous 6 months including unstable angina or angina requiring surgical or medical intervention, significant cardiac arrhythmia, or New York Heart Association (NYHA) class 3 or 4 congestive heart failure.
-Subject is a female of Childbearing Potential [defined as a sexually mature woman who (1) has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oopherectomy (the surgical removal of both ovaries) or (2) has not been naturally postmenopausal for at least 12 consecutive months (ie, has had menses at any time during the preceding 12 consecutive months)].
Age minimum:
Age maximum:
Gender:
Female: yes Male: no
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Health Condition(s) or Problem(s) studied
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Postmenopausal female subjects with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer, who have progressed on an aromatase inhibitor (AI) MedDRA version: 18.0
Level: LLT
Classification code 10006315
Term: Breast tumor malignant
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.0
Level: LLT
Classification code 10006204
Term: Breast carcinoma
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.0
Level: LLT
Classification code 10027475
Term: Metastatic breast cancer
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.0
Level: LLT
Classification code 10006283
Term: Breast neoplasm malignant female
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.0
Level: LLT
Classification code 10070575
Term: Estrogen receptor positive breast cancer
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.0
Level: PT
Classification code 10006187
Term: Breast cancer
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: Oral Azacitidine Product Code: CC-486 Pharmaceutical Form: Coated tablet INN or Proposed INN: AZACITIDINE CAS Number: 320-67-2 Current Sponsor code: CC-486 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
Product Name: Oral Azacitidine Product Code: CC-486 Pharmaceutical Form: Coated tablet INN or Proposed INN: AZACITIDINE CAS Number: 320-67-2 Current Sponsor code: CC-486 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150-
Product Name: Oral Azacitidine Product Code: CC-486 Pharmaceutical Form: Coated tablet INN or Proposed INN: AZACITIDINE CAS Number: 320-67-2 Current Sponsor code: CC-486 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Trade Name: Faslodex 250 mg solution for injection Product Name: Fulvestrant Pharmaceutical Form: Solution for injection INN or Proposed INN: fulvestrant Other descriptive name: FULVESTRANT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250-
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Primary Outcome(s)
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Main Objective: To evaluate the efficacy of CC-486 in combination with fulvestrant relative to fulvestrant monotherapy, by estimation of the hazard ratio of progression free survival (PFS)
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Timepoint(s) of evaluation of this end point: approximately 28 months after the start of enrollment
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Primary end point(s): Estimation of the hazard ratio of PFS of the combination arm relative to fulvestrant monotherapy arm
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Secondary Objective: •To estimate response rate (RR), clinical benefit rate (CBR), overall survival (OS), and duration of response (DOR) in all treatment arms •To evaluate the safety of all treatment arms
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Secondary Outcome(s)
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Secondary end point(s): •ORR: the combined incidence of CR and PR, based on RECIST Version 1.1
•Clinical benefit rate (CBR) : [Complete response (CR) + PR + SD ( = 24 weeks)]
•Overall Survival (OS): time from date of randomization to date of death due to any cause
•Duration of response in subjects with objective CR or PR
•Safety: incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), Grade 3 and higher AEs, AEs of special interest, and laboratory abnormalities and other safety parameters
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Timepoint(s) of evaluation of this end point: •ORR: approximately 28 months after the start of enrollment
•CBR: approximately 28 months after the start of enrollment
•OS: approximately 28 months after the start of enrollment
•Duration of response: approximately 28 months after the start of enrollment
•Safety: Continuous starting after signature of informed consent document, until 28 days after treatment discontinuation
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Secondary ID(s)
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CC-486-BRSTM-001
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2014-003220-52-BE
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Source(s) of Monetary Support
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Celgene Corporation
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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