A Study of RO5429083 in Patients With Metastatic and/or Locally Advanced, CD44-Expressing, Malignant Solid Tumors
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/3/2016 |
| Start Date: | June 2011 |
| End Date: | March 2014 |
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
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.
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.
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
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