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| Sponsor: | ImmunoGen, Inc. |
|---|---|
| Information provided by: | ImmunoGen, Inc. |
| ClinicalTrials.gov Identifier: | NCT00620607 |
Purpose
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: | September 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Eligibility| 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:
Contacts and Locations| United States, Alabama | |
| UAB Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| South Texas Accelerated Research Therapeutics | |
| San Antonio, Texas, United States | |
| U.T. M.D. Anderson Cancer Center | |
| Houston, Texas, United States | |
More Information
| Responsible Party: | ImmunoGen, Inc. ( Clinical Operations ) |
| Study ID Numbers: | IMGN 102 |
| Study First Received: | February 7, 2008 |
| Last Updated: | August 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00620607 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
gastric |
|
Neoplasms Stomach Diseases Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Neoplasms by Histologic Type |
Gastrointestinal Diseases Stomach Neoplasms Gastrointestinal Neoplasms Neoplasms, Glandular and Epithelial Carcinoma |