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NCT01383343 · ClinicalTrials.gov registry record · Phase 1

Sorafenib Tosylate, Bevacizumab, Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer

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

Completed
Registry status
Phase 1
Development phase
17
Enrollment target

NCT01383343: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01383343 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01383343, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).

COMPLETED
Registry status
Phase 1
Development phase
17 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of sorafenib tosylate when given together with bevacizumab, irinotecan hydrochloride, leucovorin calcium, and fluorouracil in treating patients with colorectal cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as irinotecan hydrochloride, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Sorafenib tosylate and bevacizumab may also block tumor growth in different ways by targeting certain cells. Giving sorafenib tosylate and bevacizumab together with combination chemotherapy may be a better treatment for colorectal cancer.

Interventions

  • DRUG Fluorouracil
  • BIOLOGICAL Bevacizumab
  • DRUG Irinotecan Hydrochloride
  • DRUG Leucovorin Calcium
  • DRUG Sorafenib Tosylate

Trial Details

FieldValue
Enrollment Target 17 participants
Start Date 2011-08
Est. Completion 2017-02
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01383343

The ClinicalTrials.gov registry entry for NCT01383343 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 17 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 5 interventions - of which Fluorouracil is the first listed.

NCT01383343 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01383343 about?

NCT01383343 is a clinical study titled "Sorafenib Tosylate, Bevacizumab, Irinotecan Hydrochloride, Leucovorin Calcium, and Fluorouracil in Treating Patients With Metastatic Colorectal Cancer". This phase I trial studies the side effects and best dose of sorafenib tosylate when given together with bevacizumab, irinotecan hydrochloride, leucovorin calcium, and fluorouracil in treating patients with colorectal cancer that has spread to other parts of the body. Drugs used in chemotherapy, suc...

What is the current status of trial NCT01383343?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2011-08. Estimated completion is 2017-02.

What interventions are being tested in trial NCT01383343?

The interventions under investigation include: Fluorouracil (DRUG), Bevacizumab (BIOLOGICAL), Irinotecan Hydrochloride (DRUG), Leucovorin Calcium (DRUG), Sorafenib Tosylate (DRUG).

Who is sponsoring clinical trial NCT01383343?

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.