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

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Omaveloxolone Lotion 0.5%
Drug: Omaveloxolone Lotion 3%
Drug: Vehicle Lotion
Radiation: 3D conformal radiation therapy

Registration Number: NCT02142959

Lead Sponsor: Reata, a wholly owned subsidiary of Biogen

Brief Summary: Radiation dermatitis is experienced by almost all patients (up to 95%) receiving radiation therapy for cancer. Radiation dermatitis can be a serious condition because, in addition to its direct physical complications and the resulting impact on overall quality of life, it can also be a dose-limiting toxicity requiring changes to the prescribed course of radiation therapy. The most common strategy employed in an attempt to prevent or minimize radiation dermatitis involves moisturization of the irradiated area, use of a mild soap to keep the area clean, and minimizing exposure to potential mechanical irritants, such as scratching and rough clothing. However, this strategy has been shown to lack clinically significant efficacy. Consequently, there is a clinical need for new treatments that are effective in protecting against radiotherapy-induced oxidative stress and the subsequent development of radiation dermatitis.

Based on data from previous studies in animals and humans, Reata believes that omaveloxolone (RTA 408) Lotion may effectively prevent and mitigate radiation dermatitis in oncology patients undergoing radiation therapy.

This randomized, double-blind, vehicle-controlled, parallel-group trial will study the efficacy, tolerability and safety of two concentrations of omaveloxolone (RTA 408) Lotion (3% and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is recommended.

Detailed Description: Study Sponsor, originally Reata Pharmaceuticals, Inc., is now Reata Pharmaceuticals, Inc., a wholly owned subsidiary of Biogen.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 187

Inclusion Criteria

Adult female patients (18 to 75 years of age, inclusive);
Patients diagnosed with ductal carcinoma in situ or non-inflammatory breast adenocarcinoma who have been referred for post-operative radiotherapy and have had no prior radiation treatment to that breast;
Patients planning to undergo 3D conformal radiation therapy to the whole breast (as part of breast-conservation therapy / lumpectomy) or chest wall (as part of post-mastectomy irradiation), with or without treatment of regional lymph nodes (i.e., axillary, supraclavicular, or internal mammary), using one of the following treatment schedules:
1. 45 - 50.4 Gy in 1.8 Gy per day, in addition to 10-16 Gy boost
2. 46 - 50 Gy in 2 Gy per day, in addition to 10-16 Gy boost;
Patients who received breast-conservation therapy / lumpectomy must be receiving ≥ 107% of the total radiation dose (calculated from the total radiation dose including boost) to any portion of the breast, based on radiation inhomogeneity, and/or have a breast volume ≥ 1200 cc;

Exclusion Criteria

Patients with Stage T4 or Stage IV breast cancer;
Patients with prior radiation therapy to the breast treated in this study;
Patients with type V or VI skin according to the Fitzpatrick scale;
Patients with bilateral breast cancer;
Patients receiving partial breast irradiation therapy;
Patients with uncontrolled diabetes (HbA1c > 11.0%, historical values within 6 months of screening are acceptable);
Patients with collagen vascular disease or vasculitis;
Patients with concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
Patients with active bacterial, fungal or viral skin infections;
Patients with known active hepatitis B or hepatitis C infection;
Patients who intend to use any other topical cream, lotion or preparation applied to the radiation treatment area;
Patients receiving concomitant chemotherapy during the course of the planned radiation treatment regimen. Patients are eligible if they are receiving sequential, neoadjuvant or adjuvant chemotherapy that is not anticipated to be delivered during the time course of the radiation treatment regimen.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
omaveloxolone (RTA 408) Lotion 0.5%	Omaveloxolone Lotion 0.5%	Omaveloxolone Lotion at a fixed dose of 0.5% administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)
omaveloxolone (RTA 408) Lotion 0.5%	3D conformal radiation therapy	Omaveloxolone Lotion at a fixed dose of 0.5% administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)
omaveloxolone (RTA 408) Lotion 3%	Omaveloxolone Lotion 3%	Omaveloxolone Lotion at a fixed dose of 3% administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 19 weeks)
omaveloxolone (RTA 408) Lotion 3%	3D conformal radiation therapy	Omaveloxolone Lotion at a fixed dose of 3% administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 19 weeks)
Vehicle Lotion	Vehicle Lotion	Vehicle Lotion administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)
Vehicle Lotion	3D conformal radiation therapy	Vehicle Lotion administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)

Primary Outcome Measures

Name	Time	Method
Time-averaged Effect on Radiation Dermatitis Grade Measured With Common Terminology Criteria for Adverse Events (CTCAE, v 4.03) Following 3D Conformal Radiation Therapy to the Breast Following Topical Application of Omaveloxolone Lotion or Lotion Vehicle	Day 1 of radiation treatment through the last day of radiation treatment (maximum of 19 weeks), time averaged effect on radiation dermatitis reported	CTCAE Radiation dermatitis scoring: Grade 0 = No radiation dermatitis; Grade 1 = Faint erythema or dry desquamation; Grade 2 = Moderate to brisk erythema, patchy moist desquamation, mostly confined to skin folds and creases, moderate edema; Grade 3 = Moist desquamation in areas other than skin folds and creases, bleeding induced by minor trauma or abrasion; Grade 4 = Life-threatening consequences, skin necrosis or ulceration of full thickness dermis, spontaneous bleeding from involved site, skin graft indicated; Grade 5 = Death

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (27): University of Colorado Hospital, Dept. of Radiation Oncology
🇺🇸
Aurora, Colorado, United States
Arizona Cancer Center
🇺🇸
Scottsdale, Arizona, United States
Lakeland Regional Cancer Center
🇺🇸
Lakeland, Florida, United States
Parkview Research Center
🇺🇸
Fort Wayne, Indiana, United States
Norwalk Hospital
🇺🇸
Norwalk, Connecticut, United States
Ironwood Cancer and Research Centers
🇺🇸
Mesa, Arizona, United States
St. Joseph's Hospital and Medical Center
🇺🇸
Phoenix, Arizona, United States
John B. Amos Cancer Center
🇺🇸
Columbus, Georgia, United States
St. Vincent Anderson Regional Hospital Cancer Center
🇺🇸
Anderson, Indiana, United States
Northern Indiana Cancer Research Consortium
🇺🇸
South Bend, Indiana, United States
University of Nebraska Medical Center - Eppley Cancer Center
🇺🇸
Omaha, Nebraska, United States
Willis-Knighton Cancer Center
🇺🇸
Shreveport, Louisiana, United States
Sanford Health
🇺🇸
Bismarck, North Dakota, United States
Hughes Cancer Center
🇺🇸
East Stroudsburg, Pennsylvania, United States
Mount Nittany Medical Center
🇺🇸
State College, Pennsylvania, United States
AnMed Health Cancer Center
🇺🇸
Anderson, South Carolina, United States
Spartanburg Regional Medical Center - Gibbs Cancer Center
🇺🇸
Spartanburg, South Carolina, United States
Sanford Research/USD
🇺🇸
Sioux Falls, South Dakota, United States
University of Texas Health Science Center at San Antonio
🇺🇸
San Antonio, Texas, United States
Mayo Clinic - LaCrosse
🇺🇸
La Crosse, Wisconsin, United States
Cancer Care Northwest
🇺🇸
Spokane, Washington, United States
Columbia St. Mary's
🇺🇸
Milwaukee, Wisconsin, United States
Radiation Oncology Associates - Parkview Research Center
🇺🇸
Fort Wayne, Indiana, United States
CaroMont Health Comprehensive Cancer Center
🇺🇸
Gastonia, North Carolina, United States
St. John Health System
🇺🇸
Tulsa, Oklahoma, United States
Abington Memorial Hospital
🇺🇸
Abington, Pennsylvania, United States
21st Century Oncology - Carolina Regional Cancer Center
🇺🇸
Myrtle Beach, South Carolina, United States