Endoxifen in Adults With Hormone Receptor Positive Solid Tumors
Status:
Active, not recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Background:
- Some types of cancer cells that have hormone receptors on their surfaces need the
hormone estrogen to grow. The drug tamoxifen blocks estrogen from binding to the tumor
cells, which helps to slow or stop the growth of cancer. Tamoxifen has been approved for
treatment of certain types of estrogen-linked cancers, such as breast and ovarian
cancer.
- The experimental drug Z-Endoxifen HCl (endoxifen) is related to tamoxifen, and has been
shown to work against similar estrogen-linked cancers. In many cancer patients,
tamoxifen is turned into endoxifen by enzymes in the liver; however, not all people have
the liver enzymes that can turn tamoxifen into endoxifen, which means that the drug
cannot work properly. Taking certain other drugs at the same time as tamoxifen can also
keep it from turning into endoxifen. Researchers are interested in determining whether
endoxifen tablets are effective in slowing or stopping tumor growth in individuals whose
hormone-linked tumors have not responded to standard treatment.
Objectives:
- To test the safety and effectiveness of daily endoxifen in individuals with hormone
receptor positive solid tumors that have not responded to standard treatment.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with hormone receptor positive
solid tumors (breast or other tumors), desmoid tumors, or gynecologic tumors that have not
responded to standard treatment.
Individuals with breast cancer must have had at least one prior chemotherapy regimen and one
prior hormonal regimen for metastatic disease.
Design:
- Participants will be screened with a full medical history (including prior hormone use)
and physical examination, as well as blood and urine tests, tumor imaging studies, and
an eye examination.
- Participants will take endoxifen tablets daily for 28-day cycles of treatment, and will
be asked to keep a medication diary to record any side effects.
- Participants will have regular clinic visits with blood and urine samples and imaging
studies to evaluate the cancer's response to treatment.
- Participants will continue to take endoxifen for as long as the cancer responds to the
treatment.