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| Sponsor: | ImmunoGen, Inc. |
|---|---|
| Information provided by: | ImmunoGen, Inc. |
| ClinicalTrials.gov Identifier: | NCT00721669 |
Purpose
Primary objective is to evaluate the safety and PK of IMGN388
| Condition | Intervention | Phase |
|---|---|---|
|
Solid Tumor |
Drug: IMGN388 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Dose-Escalation Study of IMGN388 in Patients With Solid Tumors |
| Estimated Enrollment: | 90 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
The secondary objectives are to assess the pharmacodynamics, immunogenicity, and tumor response of IMGN388 administered as an IV infusion once every three weeks in patients with solid tumors
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients meeting any of the following criteria may not be enrolled in the study:
Patients will continue to be followed for short term follow-up and long term survival.
Contacts and Locations| United States, Oklahoma | |
| University of Oklahoma | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Contact: Rachel Jones 405-271-8777 ext 48876 Rachel-Jones@ouhsc.edu | |
| Principal Investigator: Kathleen Moore, MD | |
| United States, Tennessee | |
| Sarah Cannon Research Institute | Recruiting |
| Nashville, Tennessee, United States | |
| Contact: Noel Wilcutt, RN, OCN 615-329-7343 noel.willcutt@scresearch.net | |
| Principal Investigator: J. Bendell, MD | |
| United States, Texas | |
| South Texas Accelerated Research Therapeutics | Withdrawn |
| San Antonio, Texas, United States, 78229 | |
More Information
| Responsible Party: | ImmunoGen, Inc, Clincial Dept |
| ClinicalTrials.gov Identifier: | NCT00721669 History of Changes |
| Other Study ID Numbers: | IMGN388 |
| Study First Received: | July 22, 2008 |
| Last Updated: | July 12, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
solid tumor |
|
Neoplasms |