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NCT01028755 · ClinicalTrials.gov registry record · Phase 1

To Determine Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors

A Phase 1 study of Neoplasms, sponsored by Bayer.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target
2
Study locations

NCT01028755 is a Phase 1 study of Neoplasms that has completed, run by Bayer. The registered enrollment target is 12 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01028755, a Phase 1 study of Neoplasms, has completed, sponsored by Bayer.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target
2
Study locations

Study Summary

This is the first time this drug will be tested in humans in order to determine the safety of the drug, the ability to tolerate the drug, to measure how the drug is used in the body and as a result of these tests to determine a maximum dose to be given. Specifically, the following aspects will be investigated: * side effects of BAY79-4620 given as infusion every three weeks * evaluation of highest and safest dose of BAY79-4620 * distribution and concentration of BAY79-4620 in the blood at specific times after administration * effect of BAY79-4620 on tumor growth * assessment of "biomarkers" (eg, analysis of specific proteins in blood samples, or analysis of tumor tissue sampled at the time of cancer diagnosis) for changes during the treatment or prediction of safety or benefits of the treatment with BAY79-4620.

Conditions Studied

Neoplasms

Interventions

  • DRUG BAY79-4620

Study Locations (2)

Tennessee

  • - Nashville

Texas

  • - San Antonio

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2009-11
Est. Completion 2013-04
Phase Phase 1

Sponsor

Bayer

591 total trials

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What the Registry Record Tells You About NCT01028755

The ClinicalTrials.gov registry entry for NCT01028755 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (99% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which BAY79-4620 is the first listed.

NCT01028755 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Tennessee, Texas.

Frequently Asked Questions

What is clinical trial NCT01028755 about?

NCT01028755 is a clinical study titled "To Determine Maximum Tolerated Dose of BAY79-4620 in Patients With Advanced Solid Tumors". This is the first time this drug will be tested in humans in order to determine the safety of the drug, the ability to tolerate the drug, to measure how the drug is used in the body and as a result of these tests to determine a maximum dose to be given. Specifically, the following aspects will be in...

What is the current status of trial NCT01028755?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2009-11. Estimated completion is 2013-04.

What conditions does trial NCT01028755 study?

This clinical trial studies the following conditions: Neoplasms.

What interventions are being tested in trial NCT01028755?

The interventions under investigation include: BAY79-4620 (DRUG).

Who is sponsoring clinical trial NCT01028755?

This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01028755 being conducted?

This trial has 2 study locations across Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

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, or report a data error.