Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments rta 408 lotion 0.5%, rta 408 lotion 3%, lotion vehicle/placebo
Phase phase 2
Sponsor Reata Pharmaceuticals, Inc.
Collaborator AbbVie
Start date June 2014
End date April 2015
Trial size 177 participants
Trial identifier NCT02142959, RTA 408-C-1306

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 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 RTA 408 Lotion (3% and 0.5%) versus vehicle in patients with breast cancer for whom radiation therapy is recommended.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
RTA 408 lotion 0.5% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
rta 408 lotion 0.5%
RTA 408 lotion 0.5% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
(Experimental)
RTA 408 lotion 3% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
rta 408 lotion 3%
RTA 408 lotion 3% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
(Placebo Comparator)
Lotion vehicle/placebo will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
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

Primary Outcomes

Measure
Grading of skin changes following radiation therapy
time frame: 9 weeks (maximum of 13 weeks)

Secondary Outcomes

Measure
Count of patients who experience a maximum radiation dermatitis grade of less than 2
time frame: 9 weeks (maximum of 13 weeks)
Grading of radiation dermatitis following radiation therapy
time frame: 9 weeks (max of 13 weeks)
Grading the duration of radiation dermatitis following radiation therapy
time frame: 9 weeks (max of 13 weeks)

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Reata Pharmaceuticals, Inc..