Skip to main content
OpenTrials
Completed

NCT Number: NCT01358903

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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Metastatic and/or locally advanced malignant CD44-expressing solid tumors
  • Patients with disease progression on standard therapy, or have tumors that are not curable by standard therapy
  • Life expectancy of over 12 weeks

Exclusion criteria

  • Concurrent therapy with any other investigational drug
  • Known or suspected CNS metastases including leptomeningeal metastases
  • Active bleeding, bleeding diathesis or history of coagulation disorder
  • Uncontrolled diabetes mellitus
  • Active or uncontrolled infections
  • Patients with HIV infections

Treatment and study plan

RO5429083

Drug

Cohorts receiving multiple escalating doses iv

Primary outcomes

  1. Arm A: Safety (Incidence of adverse events related to study drug)

    Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)

  2. Arm A: Maximum tolerated dose of RO5429083

    Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)

  3. Arm A: Tumor Growth Control Rate

    Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)

  4. Arm B: Tissue distribution of RO5429083 assessed by positron emission tomography (PET)

    Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)

  5. Arm A: Pharmacokinetics (serum levels of RO5429083)

    Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)

Secondary outcomes

  1. Arm A: Recommended dose of RO5429083 for the extension cohort

    Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)

  2. Arm A: Anti-tumor activity of RO5429083

    Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)

  3. Arm B: Target saturation of 89Zr-labelled RO5429083

    Time frame: Until disease progression or unacceptable toxicity (approximately 2 years)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
May 24, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.