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NCT01071564 · ClinicalTrials.gov registry record · Phase 1

RO4929097 and Vismodegib in Treating Patients With Breast Cancer That is Metastatic or Cannot Be Removed By Surgery

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

Terminated
Registry status
Phase 1
Development phase
13
Enrollment target

NCT01071564: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).

NCT01071564 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 13 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01071564, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).

TERMINATED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with vismodegib in treating patients with breast cancer that is metastatic or cannot be removed by surgery. RO4929097 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as vismodegib, 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. Giving RO4929097 and vismodegib together may slow the growth of tumor cells and may be a more active treatment for advanced breast cancer.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • DRUG Vismodegib
  • OTHER Pharmacological Study
  • OTHER Pharmacogenomic Study
  • DRUG Gamma-Secretase Inhibitor RO4929097

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2009-11
Est. Completion 2014-06
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

What the Registry Record Tells You About NCT01071564

The ClinicalTrials.gov registry entry for NCT01071564 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 13 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 Laboratory Biomarker Analysis is the first listed.

NCT01071564 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01071564 about?

NCT01071564 is a clinical study titled "RO4929097 and Vismodegib in Treating Patients With Breast Cancer That is Metastatic or Cannot Be Removed By Surgery". This phase I trial studies the side effects and best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with vismodegib in treating patients with breast cancer that is metastatic or cannot be removed by surgery. RO4929097 may stop the growth of tumor...

What is the current status of trial NCT01071564?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2009-11. Estimated completion is 2014-06.

What interventions are being tested in trial NCT01071564?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Vismodegib (DRUG), Pharmacological Study (OTHER), Pharmacogenomic Study (OTHER), Gamma-Secretase Inhibitor RO4929097 (DRUG).

Who is sponsoring clinical trial NCT01071564?

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.