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Selective Estrogen Receptor Modulator

Endoxifen for Hormone-Receptor-Positive Cancer

Phase 1
Waitlist Available
Led By Naoko Takebe, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with gynecologic tumors (endometrial, ovarian, uterine, fallopian tube, peritoneal, etc.)
Patients with tumors that are ER+ or PR+ by immunohistochemistry such as non-small cell lung, colorectal, and prostate
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days (1 cycle)
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of the drug endoxifen in individuals with hormone receptor positive solid tumors. Eligible participants must be 18 years or older and have had at least one prior chemotherapy and hormonal regimen for metastatic disease.

Who is the study for?
Adults over 18 with hormone receptor positive solid tumors, including breast and gynecologic cancers, that haven't improved with standard treatments. Participants must have tried at least one chemotherapy and hormonal regimen if they have breast cancer. They should not be on certain medications or have had recent major surgery, and their organ function needs to meet specific criteria.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of a drug called Z-Endoxifen in tablet form for patients whose tumors are still growing despite previous treatments. The study involves taking the medication daily in cycles, monitoring side effects through regular clinic visits, blood tests, imaging studies, and an eye exam.See study design
What are the potential side effects?
While specific side effects of Z-Endoxifen aren't listed here, similar drugs can cause hot flashes, mood swings, fatigue, joint pain or muscle cramps. There may also be risks to liver function or potential blood clots due to its estrogen-blocking action.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a cancer that started in my reproductive organs.
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My tumor is positive for estrogen or progesterone receptors.
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I have breast cancer and have been treated with tamoxifen or aromatase inhibitors.
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My organ and bone marrow functions are normal or adequate.
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My HER2+ breast cancer has worsened after at least one treatment.
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My condition worsened after receiving standard treatment.
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I am 18 years old or older.
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I have a desmoid tumor.
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My cancer is a solid tumor, including certain types of breast cancer.
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I have breast cancer and have received at least one chemotherapy treatment for it when it spread.
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I can take care of myself but might not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days (1 cycle)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days (1 cycle) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Establish safety and MTD of Z-endoxifen
Secondary outcome measures
Determine the pharmacokinetics of Z-endoxifen (free base and HCl forms)

Trial Design

1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
Z-endoxifen will be administered orally once a day in 28-day cycles

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,608 Previous Clinical Trials
40,915,293 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Naoko Takebe, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
192 Total Patients Enrolled

Media Library

Endoxifen (Selective Estrogen Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT01273168 — Phase 1
Breast Cancer Research Study Groups: 1
Breast Cancer Clinical Trial 2023: Endoxifen Highlights & Side Effects. Trial Name: NCT01273168 — Phase 1
Endoxifen (Selective Estrogen Receptor Modulator) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01273168 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants still being invited to participate in this investigation?

"As per data listed on the clinicaltrials.gov website, this medical trial is no longer engaging in recruitment efforts. This research was initially published on March 1st 2011 and last edited on December 1st 2022. Although this study has since ended its search for patients, 16 other trials are still looking to enroll individuals at present."

Answered by AI

Are there any health risks associated with Z-Endoxifen use?

"Our assessment of Z-Endoxifen's safety is rated at 1 due to its Phase 1 status, meaning there are limited studies demonstrating both its efficacy and security."

Answered by AI
~3 spots leftby Mar 2025