Endoxifen in Adults With Hormone Receptor Positive Solid Tumors

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

March 1, 2011

Primary Completion Date

June 1, 2020

Study Completion Date

June 1, 2026

Conditions
Hormone Receptor-Positive BreastGynecologicDesmoidHormone Receptor-Positive Neoplasms
Interventions
DRUG

Z-Endoxifen

Genetic polymorphisms in CYP2D6 and concomitant medications alter tamoxifen metabolism, limiting exposure to the active metabolite endoxifen. These factors are associated with a higher rate of recurrence and shorter disease-free survival in breast cancer patients receiving tamoxifen. Administration of endoxifen directly to patients is anticipated to bypass the effects of CYP2D6 polymorphisms and concomitant medications and provide adequate active drug levels in all treated patients, resulting in clinical benefit.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Cancer Institute (NCI)

NIH