Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant

PHASE2TerminatedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

March 13, 2015

Primary Completion Date

December 13, 2016

Study Completion Date

November 21, 2017

Conditions
Breast Neoplasms
Interventions
DRUG

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

DRUG

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.

Trial Locations (35)

2610

GasthuisZusters Antwerpen, Wilrijk

5000

Clinique Sainte Elisabeth - Service d'Oncologie, Namur

6000

Grand Hopital de Charleroi, Charleroi

8035

Hospital Universitario Vall D Hebron, Barcelona

8500

AZ Groeninge, Kortrijk

10021

Clinical Research Alliance, New York

10126

Azienda Ospedaliera Citta della Salute e della Scienza di Torino, Torino, Piemonte

15006

Complejo Universitario La Coruna, A Coruña

20132

Ospedale San Raffaele S.r.l., Milan

20133

Istituto Nazionale Dei Tumori, Milan

20144

IEO- Istituto Europeo di Oncologia, Milan

20246

Universitatsklinikum Hamburg-Eppendorf / IVDP, Hamburg

20249

Hamatologisch Onkologische Praxis Eppendorf, Hamburg

28007

Hospital General Gregorio Maranon, Madrid

28034

Hospital Ramon y Cajal, Madrid

29011

Hospital Clinico Universitario Virgen de La Victoria, Málaga

33076

Institut Bergonie, Borddeaux Cedex

33401

Florida Cancer Specialists, West Palm Beach

40138

Policlinico S. Orsola - Malpighi, Bologna

41013

Hospital Virgen del Rocio, Seville

42100

Arcispedale Santa Maria Nuova, Reggio Emilia

44805

Centre Rene Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique, Saint-Herblain

48202

Henry Ford Health System, Detroit

49933

Centre Regional de lutte contre le cancer Paul Papin, Angers

55131

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Mainz

66205

University of Kansas Hospital, Westwood

72703

Highlands Oncology Group, Fayetteville

75651

Hopital Pitie Salpetriere, Paris

81675

TU München - Klinikum rechts der Isar, München

85224

Ironwood Cancer and Research Center, Chandler

85258

Virginia G Piper Cancer Center, Scottsdale

99208

Medical Oncology Associates, Spokane

00161

Policlinico Umberto I, Roma

00168

Policlinico Universitario A Gemelli, Roma

08003

Hospital del Mar, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Celgene

INDUSTRY