Know Cancer

or
forgot password

A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V930/V932 in Patients With Cancer Expressing HER-2 and/or CEA


Phase 1
18 Years
N/A
Not Enrolling
Both
Cancer

Thank you

Trial Information

A Phase I Study to Evaluate the Safety/Tolerability and Immunogenicity of V930/V932 in Patients With Cancer Expressing HER-2 and/or CEA


The optional followup period for this study is 1 year after the last vaccination.


Inclusion Criteria:



- Patients must have completed surgical treatment for his/her primary disease at least
1 month prior to enrollment

- Patient must not be pregnant 3 days prior to enrollment

Exclusion Criteria:

- Patient is currently participating or has participated in a study with an
investigational compound or device within 30 days of signing informed consent

- Patient has had their spleen removed or has a history of autoimmune disorders

- Patient is a regular user of any illicit drugs or has used within the past year of
drug or alcohol abuse

- Patient is pregnant or breastfeeding or is expecting to conceive anytime following
the study

- Patient is known to be Human Immunodeficiency Virus (HIV)-seropositive

- Patient has a known history of Hepatitis B or C

- Patient has received a vaccine for any disease or condition within one month of
enrollment

- Patient has a primary central nervous system tumor.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the safety and tolerability of V930/V932 followed by EP in cancer patients

Outcome Time Frame:

Week 22

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2007_671

NCT ID:

NCT00647114

Start Date:

August 2007

Completion Date:

April 2009

Related Keywords:

  • Cancer
  • Cancers expressing HER-2 and/or CEA

Name

Location