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NCT03300557 · ClinicalTrials.gov registry record · Phase 2

Exemestane in Treating Patients With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer

A Phase 2 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 2
Development phase
40
Enrollment target

NCT03300557: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).

NCT03300557 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT03300557, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target

Study Summary

This pilot phase IIa trial studies how well exemestane works in treating patients with complex atypical hyperplasia of the endometrium/endometrial intraepithelial neoplasia or low grade endometrial cancer. Exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Primary Outcome

Will be measured by change in Ki-67 expression. Will evaluate the change from baseline to post-exposure in absolute change in percent Ki-67 using one-sample Student's t-test or Wilcoxon signed-rank test, as appropriate.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • OTHER Questionnaire Administration
  • DRUG Exemestane
  • OTHER Pharmacokinetic Study

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2017-11-15
Est. Completion 2025-08-14
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the finished NCT03300557 record still lists

NCT03300557 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).

The record links to 0 conditions, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT03300557 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03300557 about?

NCT03300557 is a clinical study titled "Exemestane in Treating Patients With Complex Atypical Hyperplasia of the Endometrium/Endometrial Intraepithelial Neoplasia or Low Grade Endometrial Cancer". This pilot phase IIa trial studies how well exemestane works in treating patients with complex atypical hyperplasia of the endometrium/endometrial intraepithelial neoplasia or low grade endometrial cancer. Exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell ...

What is the current status of trial NCT03300557?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2017-11-15. Estimated completion is 2025-08-14.

What interventions are being tested in trial NCT03300557?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Exemestane (DRUG), Pharmacokinetic Study (OTHER).

Who is sponsoring clinical trial NCT03300557?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03300557's enrollment target sits among peer trials

40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03300557, the US trial registry maintained by the National Library of Medicine. NCT03300557 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.