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

This study has been completed.
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02142959
First received: May 16, 2014
Last updated: January 27, 2016
Last verified: January 2016
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Omaveloxolone Lotion 0.5%
Drug: Omaveloxolone Lotion 3%
Drug: Lotion vehicle/Placebo
Radiation: 3D conformal radiation therapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Reata Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Grading of skin changes following radiation therapy [ Time Frame: 9 weeks (maximum of 13 weeks) ] [ Designated as safety issue: No ]
    Grading of skin changes (using CTCAE grading scale) due to treatment with radiation therapy, following topical application of RTA 408 lotion or lotion vehicle


Secondary Outcome Measures:
  • Count of patients who experience a maximum radiation dermatitis grade of less than 2 [ Time Frame: 9 weeks (maximum of 13 weeks) ] [ Designated as safety issue: No ]
    Count the number of patients who experience a maximum radiation dermatitis grade of less than 2 (based on CTCAE grading scale) due to treatment with radiation therapy, following topical application of RTA 408 lotion or lotion vehicle

  • Grading of radiation dermatitis following radiation therapy [ Time Frame: 9 weeks (max of 13 weeks) ] [ Designated as safety issue: No ]
    Calculate the mean maximum radiation dermatitis grade measured with CTCAE of RTA 408 Lotion (0.5% and 3%) compared with lotion vehicle.

  • Grading the duration of radiation dermatitis following radiation therapy [ Time Frame: 9 weeks (max of 13 weeks) ] [ Designated as safety issue: No ]
    Calculate the mean duration of grade greater than or equal to 2 radiation dermatitis using the CTCAE criteria following administration of RTA 408 Lotion compared with lotion vehicle.


Enrollment: 187
Study Start Date: June 2014
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: omaveloxolone (RTA 408) 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 0.5%
Omaveloxolone lotion 0.5% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
Other Name: RTA 408 Lotion 0.5%
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
Experimental: omaveloxolone (RTA 408) Lotion 3%
Omaveloxolone lotion 3% 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
Other Name: RTA 408 Lotion 3%
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
Placebo Comparator: Lotion vehicle/Placebo
Lotion vehicle/placebo will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
Drug: Lotion vehicle/Placebo
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02142959

  Show 27 Study Locations
Sponsors and Collaborators
Reata Pharmaceuticals, Inc.
AbbVie
  More Information

Responsible Party: Reata Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02142959     History of Changes
Other Study ID Numbers: RTA 408-C-1306 
Study First Received: May 16, 2014
Last Updated: January 27, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Reata Pharmaceuticals, Inc.:
RTA 408
RTA 408 Lotion
Breast cancer
Radiation therapy
Radiation dermatitis
Oxidative stress
Inflammation
omaveloxolone

Additional relevant MeSH terms:
Breast Neoplasms
Dermatitis
Radiodermatitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Radiation Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on August 25, 2016