NCT01792050 - Study of Chemotherapy in Combination With IDO Inhibitor in Metastatic Breast Cancer | Biotech Hunter

Enrollment

169

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

July 1, 2016

Study Completion Date

July 7, 2017

Conditions

Metastatic Breast Cancer

Interventions

DRUG

Docetaxel

Docetaxel chemotherapy regimen given by vein over 1 hour on day 8 of each cycle.

OTHER

Placebo

Placebo taken orally every morning 1 hour prior to breakfast and 1 hour prior to dinner on days 1-14. Six pills to be taken each time for a total of 12 pills per day.

DRUG

Indoximod

Indoximod (1200 mg) taken orally every morning 1 hour prior to breakfast and 1 hour prior to dinner on days 1-14. Six 200 mg pills to be taken twice a day for a total of 12 pills per day.

DRUG

Paclitaxel

Paclitaxel chemotherapy regimen given by vein over 1 hour weekly x 3 followed by a week of rest each cycle.

Trial Locations (40)

10469

Eastchester Center for Cancer Care, The Bronx

17033

Pennsylvania State University Milton S. Hershey Medical Center, Hershey

19010

Bryn Mawr Hospital, Bryn Mawr

19096

Lankenau Medical Center, Wynnewood

19301

Paoli Hospital, Paoli

22908

University of Virginia, Charlottesville

23298

Virginia Commonwealth University, Richmond

23601

Peninsula Cancer Center, Newport News

24501

Lynchburg Hematology Oncology, Lynchburg

27157

Wake Forest Baptist Hospital, Winston-Salem

27599

University of North Carolina, Chapel Hill

30607

University Cancer & Blood Center, LLC, Athens

30912

Georgia Regents University, Augusta

32610

University of Florida Health Cancer Center, Gainesville

32796

Space Coast Cancer Center, Titusville

33331

Cleveland Clinic - Florida, Weston

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

37920

University of Tennessee Medical Center, Knoxville

44111

Fairview Hospital, Cleveland

44124

Taussig Cancer Institute, Mayfield Heights

44195

Cleveland Clinic - Taussig Cancer Center, Cleveland

45626

Indiana University Health Goshen Center for Cancer Care, Goshen

52242

University of Iowa Hospitals and Clinics, Iowa City

53132

Wheaton Franciscan Healthcare- Reiman Cancer Center, Franklin

54311

Aurora Baycare, Green Bay

60005

Illinois Cancer Specialists, Arlington Heights

60612

University of Illinois Cancer Center, Chicago

77303

MD Anderson Cancer Center, Houston

36-200

Research SiteR, Brzozów

80-210

Reserach Site, Gdansk

85-519

Research Site, Gdynia

66-400

Research Site, Gorzów Wielkopolski

62-500

Reserach Site, Konin

31-115

Research Site, Krakow

10-228

Research Site, Olsztyn

10-513

Research Site, Olsztyn

60-569

Research Site, Poznan

44-200

Research Site, Rybnik

35-055

Research Site, Rzeszów

02-781

Research Site, Warsaw