Clinical trial NCT02142959: RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE
Official title: A Randomized, Double-blind, Vehicle-controlled, Parallel-group Phase 2 Study of the Efficacy, Safety, and Pharmacokinetics of RTA 408 Lotion in the Treatment of Patients at Risk for Radiation Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: RTA 408
RTA 408 Lotion
Breast cancer
Radiation therapy
Radiation dermatitis
Oxidative stress
Inflammation
omaveloxolone
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2014-05-20
Enrollment: 187
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

1. Adult female patients (18 to 75 years of age, inclusive);
2. 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;
3. 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;
4. 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:

1. Patients with Stage T4 or Stage IV breast cancer;
2. Patients with prior radiation therapy to the breast treated in this study;
3. Patients with type V or VI skin according to the Fitzpatrick scale;
4. Patients with bilateral breast cancer;
5. Patients receiving partial breast irradiation therapy;
6. Patients with uncontrolled diabetes (HbA1c \> 11.0%, historical values within 6 months of screening are acceptable);
7. Patients with collagen vascular disease or vasculitis;
8. Patients with concurrent active malignancy other than adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix;
9. Patients with active bacterial, fungal or viral skin infections;
10. Patients with known active hepatitis B or hepatitis C infection;
11. Patients who intend to use any other topical cream, lotion or preparation applied to the radiation treatment area;
12. 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.

Primary outcomes:
measure: 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
timeFrame: Day 1 of radiation treatment through the last day of radiation treatment (maximum of 19 weeks), time averaged effect on radiation dermatitis reported
Secondary outcomes:
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Cancer Center
state: Arizona
city: Aurora
country: United States
facility: University of Colorado Hospital, Dept. of Radiation Oncology
state: Colorado
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Lakeland
country: United States
facility: Lakeland Regional Cancer Center
state: Florida
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Anderson
country: United States
facility: St. Vincent Anderson Regional Hospital Cancer Center
state: Indiana
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Fort Wayne
country: United States
facility: Radiation Oncology Associates - Parkview Research Center
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Cancer Research Consortium
state: Indiana
city: Shreveport
country: United States
facility: Willis-Knighton Cancer Center
state: Louisiana
city: Omaha
country: United States
facility: University of Nebraska Medical Center - Eppley Cancer Center
state: Nebraska
city: Gastonia
country: United States
facility: CaroMont Health Comprehensive Cancer Center
state: North Carolina
city: Bismarck
country: United States
facility: Sanford Health
state: North Dakota
city: Tulsa
country: United States
facility: St. John Health System
state: Oklahoma
city: Abington
country: United States
facility: Abington Memorial Hospital
state: Pennsylvania
city: East Stroudsburg
country: United States
facility: Hughes Cancer Center
state: Pennsylvania
city: State College
country: United States
facility: Mount Nittany Medical Center
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health Cancer Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: 21st Century Oncology - Carolina Regional Cancer Center
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Regional Medical Center - Gibbs Cancer Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Research/USD
state: South Dakota
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: La Crosse
country: United States
facility: Mayo Clinic - LaCrosse
state: Wisconsin
city: Milwaukee
country: United States
facility: Columbia St. Mary's
state: Wisconsin
Study officials:
References: