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Sponsored by: |
ImmunoGen, Inc. |
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Information provided by: | ImmunoGen, Inc. |
ClinicalTrials.gov Identifier: | NCT00620607 |
To assess the response rate of huC242-DM4 given as an intravenous infusion to patients with metastatic or locally advanced gastric or gastroesophageal junction cancer.
Condition | Intervention | Phase |
---|---|---|
Stomach Neoplasms Metastatic or Locally Advanced Gastric Cancer Metastatic or Local Advanced GE Junction Cancer |
Drug: huC242-DM4 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II, Open Label, Multiple Center Study of huC242-DM4 Given as an Intravenous Infusion Once Every Three Weeks to Patients With Metastatic Gastric or Gastroesophageal Junction Carcinomas |
Estimated Enrollment: | 45 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must have adequate organ function including:
Hematopoietic:
i. Absolute neutrophil count > 1,500/mm3. ii. Platelet count > 100,000/mm3. iii. Hemoglobin > 9 g/dL (transfusion allowed).
Renal:
i. Serum creatinine ≤ 1.5 x the upper limit of normal (ULN) ii. Calculated creatinine clearance > 60 mL/min/1.73m2.
Hepatic:
i. Alanine aminotransferase (ALT), or aspartate aminotransferase (AST) ≤ 2.5 x ULN ii. Total bilirubin ≤ 1.5 x ULN
Exclusion Criteria:
Contact: Tony Tolcher, MD | 210-593-5250 | atolcher@start.stoh.com |
United States, Alabama | |
UAB Comprehensive Cancer Center | Recruiting |
Birmingham, Alabama, United States, 35294 | |
Contact: James A. Posey, MD 205-934-0916 james.posey@ccc.uab.edu | |
Principal Investigator: James A Posey, MD | |
United States, Tennessee | |
Vanderbilt-Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Research Trials 800-811-8480 | |
Principal Investigator: Laura Goff, MD | |
United States, Texas | |
South Texas Accelerated Research Therapeutics | Recruiting |
San Antonio, Texas, United States | |
Contact: Tony Tolcher, MD 210-593-5250 atolcher@start.stoh.com | |
Principal Investigator: Tony Tolcher, MD | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States | |
Contact: Alexandria Phan, MD 713-792-2828 aphan@mdanderson.org | |
Principal Investigator: Alexandria Phan, MD |
Responsible Party: | ImmunoGen, Inc. ( VP of Clinical Operations ) |
Study ID Numbers: | IMGN 102 |
Study First Received: | February 7, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00620607 |
Health Authority: | United States: Food and Drug Administration |
gastric |
Stomach Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases |
Stomach Neoplasms Gastrointestinal Neoplasms Stomach cancer Carcinoma |
Neoplasms Neoplasms by Site |