Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Wounds and Injuries

Inflammation

Breast Neoplasms

Dermatitis

Radiodermatitis

Skin Diseases

Radiation Injuries

Omaveloxolone Lotion at a fixed dose of 0.5% administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)

Omaveloxolone Lotion at a fixed dose of 3% administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 19 weeks)

Vehicle Lotion administered topically to the radiation area, twice daily for approximately 9 weeks (up to a maximum of 16 weeks)

Omaveloxolone lotion 0.5% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy

Omaveloxolone Lotion 0.5%

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

Omaveloxolone Lotion 3%

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

Vehicle Lotion

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

3D conformal radiation therapy

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.

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

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

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

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

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

AbbVie

Reata, a wholly owned subsidiary of Biogen

Omaveloxolone (RTA 408) Lotion 0.5%

Omaveloxolone (RTA 408) Lotion 3%

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Intent-to-treat population (all randomized patients whether or not they received study drug)

US Biogen Clinical Trial Center

Comparison of omaveloxolone lotion pooled (0.5% and 3%) versus vehicle lotion

Comparison of Omaveloxolone Lotion 0.5% versus Vehicle Lotion

Comparison of Omaveloxolone Lotion 3% versus Vehicle Lotion

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

Overall Study

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Within 24 weeks of surgical resection, patients undergo conformal radiation therapy once daily 5 days per week for 28 fractions. Treatment continues in the absence of disease progression or unacceptable toxicity.

Joseph W Shelton, MD

This phase II trial studies how well modern, conformal radiation therapy after surgery works in treating patients with high-risk bladder cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PRIMARY OBJECTIVE:

I. Determine the feasibility of adjuvant radiation in the management of high-risk disease.

SECONDARY OBJECTIVES:

I. Prospectively evaluate patterns of failure in high-risk bladder cancer patients after cystectomy and aggressive adjuvant therapy.

II. Define surgical and histopathologic parameters predictive of local and distant outcomes (e.g. grade, lymphovascular space invasion \[LVSI\], extent of resection/lymph node dissection \[LND\]).

III. Assess quality of life (QoL) outcomes after this treatment using a standardized questionnaires (Functional Assessment of Cancer Therapy-General \[FACT-G\], FACT-Bladder Cancer \[BL\], Expanded Prostate Cancer Index Composite \[EPIC\] Bowel and Urinary).

OUTLINE:

Within 24 weeks of surgical resection, patients undergo 3D conformal radiation therapy once daily 5 days per week for 28 fractions. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 4 weeks, every 3 months for 2 years, every 6 months for 3-5 years, and then annually thereafter.

Adjuvant Radiation for High Risk Bladder Cancer

Phase II Study of Adjuvant 3D-Conformal Radiotherapy in High Risk Bladder Cancer

For purposes of this study, "bowel adverse events" are defined as the following: diarrhea, enteritis, fistula, ileus, incontinence, obstruction, perforation, proctitis, and stricture/stenosis (including anastomotic) as graded buy Common Terminology for Adverse Events (CTCAE) version 4.0.

The cumulative incidence approach will be used to estimate the failure rate for local-regional and distant failures.

Nodal disease beyond the common iliac will be considered distant failure. The cumulative incidence approach will be used to estimate the failure rate for distant failure.

Any tumor recurrence, development of distant metastases or death is considered a failure. The Kaplan-Meier method will be used to estimate the disease-free survival rate.

Death from any cause is considered a failure. The Kaplan-Meier method will be used to estimate the overall survival.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
RTA 408 Lotion in Patients at Risk for Radiation Dermatitis - PRIMROSE	NCT02142959	Breast Cancer	Omaveloxolone L... Omaveloxolone L... Vehicle Lotion 3D conformal ra...	18 Years - 75 Years	Biogen
Adjuvant Radiation for High Risk Bladder Cancer	NCT01954173	Bladder Cancer Squamous Cell C... Stage III Bladd... Stage IV Bladde... Transitional Ce...	3D conformal ra...	18 Years -	Emory University

Spots Global Cancer Trial Database for 3d conformal radiation therapy