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



Status:Completed
Conditions:Breast Cancer, Cancer, Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery, Oncology
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:June 2014
End Date:April 2015

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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

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.


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.
We found this trial at
27
sites
Norwalk, Connecticut 06856
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3525
Lakeland, Florida 33805
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Lakeland, FL
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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San Antonio, TX
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Abington, PA
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Anderson, IN
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2000 E Greenville St
Anderson, South Carolina 29621
(864) 512-4640
AnMedical Health Cancer Center Cancer is the general term for a group of more than...
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Anderson, SC
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Aurora, CO
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Bismarck, North Dakota 58501
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Bismarck, ND
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1831 Fifth Avenue
Columbus, Georgia 31904
(706) 320-8700
John B. Amos Cancer Center The John B. Amos Cancer Center located in Columbus, Georgia,...
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Columbus, GA
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East Stroudsburg, Pennsylvania 18301
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East Stroudsburg, PA
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Fort Wayne, Indiana 46805
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Fort Wayne, IN
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Gastonia, North Carolina 28054
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LaCrosse, Wisconsin 54601
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LaCrosse, WI
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Mesa, AZ
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Milwaukee, Wisconsin 53211
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Myrtle Beach, South Carolina 29577
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Omaha, NE
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350 W Thomas Rd
Phoenix, Arizona 85013
(602) 406-3000
St. Joseph's Hospital and Medical Center St. Joseph's is a nationally recognized center for quality...
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Scottsdale, Arizona 85258
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Shreveport, Louisiana 71103
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Sioux Falls, South Dakota 57104
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615 N Michigan Street
South Bend, Indiana 46601
(574) 647-7370
Northern Indiana Cancer Research Consortium The Northern Indiana Cancer Research Consortium (NICRC) is comprised of...
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South Bend, IN
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Spokane, Washington 99218
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1800 E Park Ave
State College, Pennsylvania 16803
(814) 231-7000
Mount Nittany Medical Center Mount Nittany Medical Center is a 260-bed acute care facility offering...
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Tulsa, Oklahoma 74104
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Tulsa, OK
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