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Sponsored by: |
Immunomedics, Inc. |
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Information provided by: | Immunomedics, Inc. |
ClinicalTrials.gov Identifier: | NCT00041691 |
The purpose of this trial is to determine the safety of 90Y-hMN14 at different dose levels in the treatment of residual colorectal cancer following recent surgery.
Condition | Intervention | Phase |
---|---|---|
Colorectal Neoplasms |
Drug: hMN14 (labetuzumab) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety Study |
Official Title: | A Phase I, Single Dose Escalating Study to Investigate the Tolerability, Pharmacokinetics and Dosimetry of 90 Y-Humanized MN-14 IgG in Colorectal Cancer Patients With Limited Residual Disease After Primary or Salvage Surgery |
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:
United States, District of Columbia | |
Washington Hospital Center | |
Washington, District of Columbia, United States, 20010 | |
United States, Washington | |
Virginia Mason Medical Center | |
Seattle, Washington, United States, 98101 |
Study Chair: | Lauri Welles, MD | Immunomedics, Inc. |
Study Director: | Terence Rugg, MD | Immunomedics, Inc. |
Study ID Numbers: | IM-T-hMN14-06 |
Study First Received: | July 12, 2002 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00041691 |
Health Authority: | United States: Food and Drug Administration |
Colorectal Cancer Colon Cancer Rectal Cancer |
Colorectal Neoplasms Colorectal Carcinoma Colorectal Tumor |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Intestinal Neoplasms |
Carcinoma Rectal neoplasm Digestive System Diseases Gastrointestinal Neoplasms Rectal cancer Colorectal Neoplasms |
Neoplasms Neoplasms by Site |