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Sponsored by: |
XOMA (US) LLC |
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Information provided by: | XOMA (US) LLC |
ClinicalTrials.gov Identifier: | NCT00051675 |
The purpose of this study is to evaluate the safety, immunogenicity, and tolerability of a monoclonal antibody administered subcutaneously in the treatment of advanced cancers of the ovary, breast, lung, prostate, colon or rectum that are either refractory to standard therapies or for which therapies that may potentially be of major benefit do not exist.
Condition | Intervention | Phase |
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Adenocarcinoma |
Drug: ING-1(heMAb) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | An Open-Label, Multi-Dose, Phase I, Dose-Escalating Study of a Subcutaneously Administered Human-Engineered Monoclonal Antibody, ING-1(heMAb), in Subjects With Advanced Adenocarcinomas |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Subject has adequate organ function defined as follows:
Hematologic:
Hepatic:
Exclusion Criteria
Study ID Numbers: | INCA104 |
Study First Received: | January 14, 2003 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00051675 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adenocarcinoma monoclonal antibody |
Antibodies, Monoclonal Antibodies Immunologic Factors Adenocarcinoma |
Immunoglobulins Neoplasms, Glandular and Epithelial Carcinoma |
Antibodies, Monoclonal Antibodies Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Physiological Effects of Drugs Adenocarcinoma Pharmacologic Actions Neoplasms, Glandular and Epithelial Carcinoma |