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NCT00001504 · ClinicalTrials.gov registry record · Phase 1

A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients

A Phase 1 study, sponsored by National Cancer Institute (NCI).

Completed
Registry status
Phase 1
Development phase
18
Enrollment target

NCT00001504: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT00001504 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 18 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00001504, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
18 participants
Enrollment target

Study Summary

This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for up to 28 weeks, with tamoxifen continued after the study if medically appropriate.

Interventions

  • DRUG 9-cis-Retinoic Acid

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 1996-05
Est. Completion 2002-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT00001504

The ClinicalTrials.gov registry entry for NCT00001504 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which 9-cis-Retinoic Acid is the first listed.

NCT00001504 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00001504 about?

NCT00001504 is a clinical study titled "A Phase I Trial of Tamoxifen and 9-Cis-Retinoic Acid in Breast Cancer Patients". This is a dosage escalation study to estimate the maximum tolerated dose of 9-cis-retinoic acid given in combination with tamoxifen. Groups of 3 to 6 patients receive oral 9-cis-retinoic acid daily for 4 weeks, after which daily oral tamoxifen is added to the regimen. Patients continue treatment for...

What is the current status of trial NCT00001504?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 1996-05. Estimated completion is 2002-01.

What interventions are being tested in trial NCT00001504?

The interventions under investigation include: 9-cis-Retinoic Acid (DRUG).

Who is sponsoring clinical trial NCT00001504?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.