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
Phase 1
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Neoplasms
Both
Neoplasms
Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Arm A: Pharmacokinetics (serum levels of RO5429083)
Outcome Time Frame:
Until disease progression or unacceptable toxicity (approximately 2 years)
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
United States: Food and Drug Administration
Study ID:
BP25385
NCT ID:
NCT01358903
Start Date:
June 2011
Completion Date:
March 2015
Related Keywords:
- Neoplasms
- Neoplasms
Name | Location |
|---|---|
| Austin, Texas 78705 | |
| Seattle, Washington 98195 |
