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NCT01358903 · ClinicalTrials.gov registry record · Phase 1

A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

A Phase 1 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 1
Development phase
65
Enrollment target

NCT01358903 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 65 participants.

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The verdict

NCT01358903, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 1
Development phase
65 participants
Enrollment target

Study Summary

This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Part B, patients will receive 89Zr-labelled RO5429083 in Cycles 1 and/or 2, followed by RO5429083. For all patients there will be an option to continue treatment with RO5429083 until disease progression or unacceptable toxicity occurs.

Interventions

  • DRUG RO5429083

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2011-06
Est. Completion 2014-03
Phase Phase 1

Sponsor

Hoffmann-La Roche

909 total trials

What the Registry Record Tells You About NCT01358903

The ClinicalTrials.gov registry entry for NCT01358903 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which RO5429083 is the first listed.

NCT01358903 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01358903 about?

NCT01358903 is a clinical study titled "A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors". This open-label 2-arm study will assess the pharmacokinetics, pharmacodynamics, safety and efficacy of RO5429083 in patients with metastatic and/or locally advanced CD44-expressing malignant solid tumors. In Part A, cohorts of patients will receive RO5429083 intravenously at escalating doses. In Par...

What is the current status of trial NCT01358903?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2011-06. Estimated completion is 2014-03.

What interventions are being tested in trial NCT01358903?

The interventions under investigation include: RO5429083 (DRUG).

Who is sponsoring clinical trial NCT01358903?

This trial is sponsored by Hoffmann-La Roche, which has 909 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, or report a data error.