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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142959
• Other study ID #: RTA 408-C-1306
• Status: Completed
• Phase: Phase 2
• Start date: June 30, 2014
• Est. completion date: April 30, 2015

Study information

• Verified date: February 2024
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: April 30, 2015
• Est. primary completion date: April 30, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Dermatitis
• Radiodermatitis

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Reata, a wholly owned subsidiary of Biogen	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Day 1 of radiation treatment through the last day of radiation treatment (maximum of 19 weeks), time averaged effect on radiation dermatitis reported