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

Complete title: Open-Label Multicenter Phase I Study of RO5429083 with Dose-Escalation and Extension Cohorts in Patients with Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors

Research Study Number       20111743
    
Principal Investigator       Andrew Coveler, MD
    
Phase       I

Look up trial at NIH

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

- Ages Eligible for Study: 18 Years and older

- Genders Eligible for Study: Both

- 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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

Other exclusion criteria may apply.



Research Study Number       20111743
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
    

Keywords
Solid Tumors

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