Skin Toxicity
Study Title
A Pilot Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of MTS-01 for the Prevention of Acute Skin Toxicity Induced by Radiotherapy (Protocol No. MITO-03-03)
Study Objectives
The objectives of this study are to determine the safety, pharmacokinetics, and preliminary efficacy of MTS-01 in any patient receiving definitive radiation therapy who the attending radiation oncologist believes is at significant risk for acute skin toxicity and in whom skin protection would not lead to an increased risk of cancer recurrence. Examples would include colorectal cancer patients, head and neck cancer patients, brain tumor patients, lung cancer patients, breast cancer patients and esophageal cancer patients.
Study Medications
MTS-01 (Tempol; 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl) is a piperidine nitroxide. The drug product is a topical gel containing 70 mg/mL of Tempol plus water, ethanol, and hydroxypropyl cellulose. The dose of MTS-01 is up to 100 mL of a 70 mg/mL Tempol gel necessary to cover the skin area exposed to radiotherapy with the maximum total dose of 7 g (100 mL).
Study Design
This study is a multi-center, open label, pilot study of MTS-01 in patients who are scheduled to undergo radiotherapy for various forms of cancer in which the radiation oncologist determines that the patient is at risk of developing radiation induced skin damage secondary to the radiation treatment. As there is no dose escalation in this study, pharmacokinetic, safety, and preliminary efficacy data will be collected at a single dose level only. The Company reserves the possibility to advance the study to include additional cohorts of patients based on this pilot study in subsequent amendments.
Study Population
Thirty patients (30) from up to 6 centers will be enrolled.
Study Duration
The total duration of the study for each patient is estimated to be 15 weeks.
Study Procedures
Prior to each daily radiation treatment, MTS-01 will be applied to the radiotherapy-exposed skin area, allowed to dry thoroughly, and then the patient may proceed to radiation therapy. The Tempol can be removed immediately following radiation with warm, soapy water so as not to irritate the irradiated area. Subjects will be evaluated for acute skin toxicity weekly during treatment and for 4 weeks following treatment using the Radiation Therapy Oncology Group "Acute Radiation Morbidity Scoring Criteria" for skin. Safety will be assessed throughout the treatment period and for up to 4 weeks following treatment. Blood samples collected after the first, twelfth, and final MTS-01 administration will be measured for Tempol concentration.