A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V-930 in Patients With Cancers Expressing HER-2 and/or CEA
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Cancers Expressing HER-2 and/or CEA
Both
Cancers Expressing HER-2 and/or CEA
Trial Information
A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V-930 in Patients With Cancers Expressing HER-2 and/or CEA
Inclusion Criteria:
- Patients must have stages II, III, or IV breast, colorectal, ovaria, of non-small
cell lung cancer
- Patients will either be disease free following primary therapy or have advanced
disease with a durable response (>3 months) after standard therapy
- Tumor antigen HER-2 and/or CEA must be measurable in the blood or detected by
Immunohistochemistry staining of the biopsies obtained from the primary tumor or
metastasis
Exclusion Criteria:
- Patients with prior treatment with any HER-2 and/or CEA containing vaccine
- Patients who have significant cardiac disease
- Patients with autoimmune disorders
- Patients who are pregnant or lactating
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2005_047
NCT ID:
NCT00250419
Start Date:
October 2005
Completion Date:
September 2008
Related Keywords:
- Cancers Expressing HER-2 and/or CEA
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