RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE

PHASE2CompletedINTERVENTIONAL
Enrollment

187

Participants

Timeline

Start Date

June 30, 2014

Primary Completion Date

April 30, 2015

Study Completion Date

April 30, 2015

Conditions
Breast Cancer
Interventions
DRUG

Omaveloxolone Lotion 0.5%

Omaveloxolone lotion 0.5% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy

DRUG

Omaveloxolone Lotion 3%

Omaveloxolone lotion 3% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy

DRUG

Vehicle Lotion

Lotion vehicle manufactured to mimic RTA 408 lotion will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy

RADIATION

3D conformal radiation therapy

45 50.4 Gy in 1.8 Gy per day, in addition to 10 - 16 Gy boost or 46 - 50 Gy in 2 Gy per day, in addition to 10 - 16 Gy boost, at the physician's discretion

Trial Locations (27)

16803

Mount Nittany Medical Center, State College

18301

Hughes Cancer Center, East Stroudsburg

19001

Abington Memorial Hospital, Abington

28054

CaroMont Health Comprehensive Cancer Center, Gastonia

29303

Spartanburg Regional Medical Center - Gibbs Cancer Center, Spartanburg

29577

21st Century Oncology - Carolina Regional Cancer Center, Myrtle Beach

29621

AnMed Health Cancer Center, Anderson

31904

John B. Amos Cancer Center, Columbus

33805

Lakeland Regional Cancer Center, Lakeland

46016

St. Vincent Anderson Regional Hospital Cancer Center, Anderson

46628

Northern Indiana Cancer Research Consortium, South Bend

46845

Parkview Research Center, Fort Wayne

Radiation Oncology Associates - Parkview Research Center, Fort Wayne

53211

Columbia St. Mary's, Milwaukee

54601

Mayo Clinic - LaCrosse, La Crosse

57104

Sanford Research/USD, Sioux Falls

58501

Sanford Health, Bismarck

68198

University of Nebraska Medical Center - Eppley Cancer Center, Omaha

71103

Willis-Knighton Cancer Center, Shreveport

74104

St. John Health System, Tulsa

78229

University of Texas Health Science Center at San Antonio, San Antonio

80045

University of Colorado Hospital, Dept. of Radiation Oncology, Aurora

85013

St. Joseph's Hospital and Medical Center, Phoenix

85206

Ironwood Cancer and Research Centers, Mesa

85258

Arizona Cancer Center, Scottsdale

99202

Cancer Care Northwest, Spokane

06856

Norwalk Hospital, Norwalk

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

AbbVie

INDUSTRY

lead

Biogen

INDUSTRY