Study of ST266 Versus Saline in Treating Skin Irritation From Radiation

Completed · Phase 1

Conditions studied: Radiation-induced Dermatitis

In brief

The objective of this study is to evaluate the safety and efficacy of ST266 in treating radiation burns of the skin in patients undergoing treatments for breast cancer and to compare ST266 treated burns with those treated with saline placebo controls.

Key facts

Study ID

NCT01714973

Run by

Noveome Biotherapeutics, formerly Stemnion

People needed

20

Starts

2012-10-01

Expected to finish

2015-10-01

Last updated by the study team

2019-05-13

Who can join

Age: 18 and older, up to 80. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• A signed IRB - approved Informed Consent;
• Women 18 - 80 years of age;
• Biopsy-proven diagnosis of breast cancer with the tumor surgically removed.
• Whole breast radiation with or without ipsilateral axilla radiation therapy recommended by her radiation oncologist.
• If a woman is of child-bearing potential, she and her partner must use an effective form of birth control.
• Willing to participate in the clinical study and comply with the requirements of the trial.

You may not qualify if…

• Abnormal liver or kidney function studies being greater than 2x the upper limit of normal.
• Patients on hemodialysis
• Psychiatric condition or substance abuse which in the Investigator's opinion may pose a threat to patient compliance;
• History of non-compliance with treatment or clinical visit attendance.
• Participation in an investigational trial within 30 days of study entry.
• Women who are pregnant or lactating

Where it is running

• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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