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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
Must not have
Patients with untreated spinal cord metastases or metastases close to vital organs
Patients with a history of deep vein thrombosis not on anti-coagulation therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days (1 cycle)
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have cancer spread to my spine or near vital organs that hasn't been treated.
Select...
I have had deep vein thrombosis but am not on blood thinners.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Establish safety and MTD of Z-endoxifen

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
13,958 Previous Clinical Trials
41,112,540 Total Patients Enrolled
Naoko Takebe, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
192 Total Patients Enrolled
Alice P Chen, M.D.Principal InvestigatorNational Cancer Institute (NCI)
18 Previous Clinical Trials
3,791 Total Patients Enrolled

Media Library

Endoxifen (Selective Estrogen Receptor Modulator) Clinical Trial Eligibility Overview. Trial Name: NCT01273168 — Phase 1
Cancer Research Study Groups: 1
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
~3 spots leftby Dec 2025
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