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NCT02859415 · ClinicalTrials.gov registry record · Phase 1

Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in People With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Neoplasms With Pleuropulmonary Metastases

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

Terminated
Registry status
Phase 1
Development phase
3
Enrollment target

NCT02859415: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT02859415 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 3 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02859415, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).

TERMINATED
Registry status
Phase 1
Development phase
3 participants
Enrollment target

Study Summary

Background: Mithramycin is a new cancer drug. In another study, people with chest cancer took the drug 6 hours a day for 7 straight days. Many of them had liver damage as a side effect. It was discovered that only people with certain genes got this side effect. Researchers want to test mithramycin in people who do not have those certain genes. Objectives: To find the highest safe dose of mithramycin that can be given to people with chest cancer who have certain genes over 24 hours instead of spread out over a longer period of time. To see if mithramycin given as a 24-hour infusion shrinks tumors. Eligibility: People ages 18 and older who have chest cancer that is not shrinking with known therapies, and whose genes will limit the chance of liver damage from mithramycin Design: Participants will be screened with: * Medical history * Physical exam * Blood and urine tests * Lung and heart function tests * X-rays or scans of their tumor * Liver ultrasound * Tumor biopsy * Participants will be admitted to the hospital overnight. A small plastic tube (catheter) will be inserted in the arm or chest. They will get mithramycin through the catheter over about 24 hours. * If they do not have bad side effects or their cancer does not worsen, they can repeat the treatment every 14 days. * Participants will have multiple visits for each treatment cycle. These include repeats of certain screening tests. * After stopping treatment, participants will have weekly visits until they recover from any side effects.

Interventions

  • DRUG Mithramycin

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2019-08-08
Est. Completion 2021-12-01
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT02859415

The ClinicalTrials.gov registry entry for NCT02859415 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 3 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 Mithramycin is the first listed.

NCT02859415 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02859415 about?

NCT02859415 is a clinical study titled "Continuous 24h Intravenous Infusion of Mithramycin, an Inhibitor of Cancer Stem Cell Signaling, in People With Primary Thoracic Malignancies or Carcinomas, Sarcomas or Germ Cell Neoplasms With Pleuropulmonary Metastases". Background: Mithramycin is a new cancer drug. In another study, people with chest cancer took the drug 6 hours a day for 7 straight days. Many of them had liver damage as a side effect. It was discovered that only people with certain genes got this side effect. Researchers want to test mithramycin ...

What is the current status of trial NCT02859415?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2019-08-08. Estimated completion is 2021-12-01.

What interventions are being tested in trial NCT02859415?

The interventions under investigation include: Mithramycin (DRUG).

Who is sponsoring clinical trial NCT02859415?

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.