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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT01358903

Public ClinicalTrials.gov record NCT01358903. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 7, 2026, 11:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Open-Label Multicenter 2-Arm Phase I Study of RO5429083 With Dose-Escalation and Extension Cohorts, and Imaging Cohorts With RO5429083 and 89Zr-labeled RO5429083, in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01358903
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Hoffmann-La Roche
Industry
Enrollment
65 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 2011 (Type not available)
Primary completion
Mar 2014 (Actual)
Completion
Mar 2014 (Actual)
Last update posted
Nov 2, 2016

2011 – 2014

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Not listed Houston Texas 77030 —
Not listed Seattle Washington 98109 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01358903, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 2, 2016 · Synced Oct 7, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01358903 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →