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| Sponsored by: |
Immunomedics, Inc. |
|---|---|
| Information provided by: | Immunomedics, Inc. |
| ClinicalTrials.gov Identifier: | NCT00041652 |
Purpose
The purpose of this trial is to determine the safety of hMN14 at different dose levels in the treatment of either colorectal or breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer Colon Cancer Rectal Cancer Colorectal Neoplasms Colorectal Carcinoma Breast Cancer Breast Neoplasms |
Drug: hMN14 (labetuzumab) |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
| Official Title: | A Phase I/II Clinical Trial of Immunotherapy With Humanized MN-14 IgG in Recurrent, Metastatic, Unresectable Colorectal and Breast Carcinomas |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Disease Characteristics:
Prior/Concurrent Therapy:
Patient Characteristics/Inclusion Criteria:
Contacts and Locations| United States, California | |
| Hoag Cancer Center | |
| Newport Beach, California, United States, 92658 | |
| Study Director: | Terence Rugg, MD | Immunomedics, Inc. |
| Study Chair: | Lauri Welles, MD | Immunomedics, Inc. |
More Information
| Study ID Numbers: | IM-T-hMN14-04 |
| Study First Received: | July 11, 2002 |
| Last Updated: | October 21, 2005 |
| ClinicalTrials.gov Identifier: | NCT00041652 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Colorectal Cancer Colon Cancer Rectal Cancer Colorectal Neoplasms |
Colorectal Carcinoma Breast Cancer Breast Neoplasms |
|
Digestive System Neoplasms Skin Diseases Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Rectal Neoplasm Breast Neoplasms Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Carcinoma Rectal Cancer Digestive System Diseases Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms Breast Diseases Neoplasms, Glandular and Epithelial |
|
Digestive System Neoplasms Neoplasms by Histologic Type Skin Diseases Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Breast Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Carcinoma Neoplasms Digestive System Diseases Neoplasms by Site Gastrointestinal Neoplasms Colonic Neoplasms Colorectal Neoplasms Breast Diseases Neoplasms, Glandular and Epithelial |