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

Completed · Phase 1

Conditions studied: Neoplasms

In brief

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.

Key facts

Study ID

NCT01358903

Run by

Hoffmann-La Roche

People needed

65

Starts

2011-06-01

Expected to finish

2014-03-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Houston, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Paris, France
• Study site — Toulouse, France
• Study site — Amsterdam, Netherlands
• Study site — Nijmegen, Netherlands

Full record on ClinicalTrials.gov

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