Clinical Trials

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SCCA Clinical Studies: Phase 1 Program

RO5429083 Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors (UW11004)
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
Status Conditions Phase Study ID
Closed Neoplasms Phase I NCT01358903

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 (Arm A and extension)/squamous cell carcinoma of the head and neck (Part B). 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.

Andrew L. Coveler, MD
SCCA Phase 1 Program Office 206-288-7551 Refer Patient
Eligibility Criteria (must meet the following to participate in this study)
  • Adult patients, >/= 18 years of age
  • Metastatic and/or locally advanced malignant CD44-expressing solid tumors (Arm A)
  • Metastatic and/or locally advanced malignant CD44-expressing squamous cell carcinoma of the head and neck (Arm B)
  • Patients with disease progression on standard therapy, or have tumors that are not curable by standard therapy
  • Life expectancy of over 12 weeks
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
Last Updated
April 11, 2014
See this trial at
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.