Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant
NCT ID: NCT02374099
Last Updated: 2018-12-14
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
97 participants
INTERVENTIONAL
2015-03-13
2017-11-21
Brief Summary
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Detailed Description
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Approximately 92 participants will be enrolled and assigned randomly in a 1:1 ratio to one of two treatment arms:
* Arm A: CC-486 300 mg and fulvestrant 500 mg: 46 subjects
* Arm B: Fulvestrant 500 mg: 46 subjects Each cycle will be 28 days. CC-486 will be administered orally at a dose of 300 mg daily on days 1-21 of each 28-day cycle. Fulvestrant will be administered by intramuscular (IM) injection at a dose of 500 mg on days 1 and 15 of cycle 1 and day 1 of subsequent cycles.
Safety will be evaluated by an independent data monitoring committee (DMC) after a total of approximately 32 subjects have completed at least 1 treatment cycle.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CC-486 and fulvestrant
CC-486 300 mg by mouth (PO) daily on days 1-21 of each 28 day cycle and fulvestrant 500mg by intramuscular (IM) injection on Days 1 and 15 of cycle 1 and day 1 of each subsequent cycle every 28 days.
CC-486
Each cycle will be 28 days. CC-486 will be administered orally at a dose of 300 mg daily on days 1-21 of each 28-day cycle
Fulvestrant
Fulvestrant will be administered by intramuscular (IM) injection at a dose of 500 mg on days 1 and 15 of cycle 1 and day 1 of subsequent cycles.
Fulvestrant
Fulvestrant will be administered by intramuscular injection at a dose of 500 mg on days 1 and 15 of cycle 1 and day 1 of subsequent cycles.
Fulvestrant
Fulvestrant will be administered by intramuscular (IM) injection at a dose of 500 mg on days 1 and 15 of cycle 1 and day 1 of subsequent cycles.
Interventions
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CC-486
Each cycle will be 28 days. CC-486 will be administered orally at a dose of 300 mg daily on days 1-21 of each 28-day cycle
Fulvestrant
Fulvestrant will be administered by intramuscular (IM) injection at a dose of 500 mg on days 1 and 15 of cycle 1 and day 1 of subsequent cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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 \[defined as a sexually mature woman who (1) has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oopherectomy (the surgical removal of both ovaries) or (2) has not been naturally postmenopausal for at least 12 consecutive months (ie, has had menses at any time during the preceding 12 consecutive months)\].
18 Years
FEMALE
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Ileana Elias, MD
Role: STUDY_DIRECTOR
Celgene
Locations
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Ironwood Cancer and Research Center
Chandler, Arizona, United States
Virginia G Piper Cancer Center
Scottsdale, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Florida Cancer Specialists
West Palm Beach, Florida, United States
University of Kansas Hospital
Westwood, Kansas, United States
Henry Ford Health System
Detroit, Michigan, United States
Clinical Research Alliance
New York, New York, United States
Medical Oncology Associates
Spokane, Washington, United States
Grand Hopital de Charleroi
Charleroi, , Belgium
AZ Groeninge
Kortrijk, , Belgium
Clinique Sainte Elisabeth - Service d'Oncologie
Namur, , Belgium
GasthuisZusters Antwerpen
Wilrijk, , Belgium
Centre Regional de lutte contre le cancer Paul Papin
Angers, , France
Institut Bergonie
Borddeaux Cedex, , France
Hopital Pitie Salpetriere
Paris, , France
Centre Rene Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique
Saint-Herblain, , France
Universitatsklinikum Hamburg-Eppendorf / IVDP
Hamburg, , Germany
Hamatologisch Onkologische Praxis Eppendorf
Hamburg, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
TU München - Klinikum rechts der Isar
München, , Germany
Policlinico S. Orsola - Malpighi
Bologna, , Italy
Ospedale San Raffaele S.r.l.
Milan, , Italy
Istituto Nazionale Dei Tumori
Milan, , Italy
IEO- Istituto Europeo di Oncologia
Milan, , Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, , Italy
Policlinico Umberto I
Roma, , Italy
Policlinico Universitario A Gemelli
Roma, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino, Piemonte, , Italy
Complejo Universitario La Coruna
A Coruña, , Spain
Hospital del Mar
Barcelona, , Spain
Hospital Universitario Vall D Hebron
Barcelona, , Spain
Hospital General Gregorio Maranon
Madrid, , Spain
Hospital Ramon y Cajal
Madrid, , Spain
Hospital Clinico Universitario Virgen de La Victoria
Málaga, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Countries
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Other Identifiers
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CC-486-BRSTM-001
Identifier Type: -
Identifier Source: org_study_id