Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352131
Status:
COMPLETED
Last Update Posted:
2010-03-17
First Post:
2006-07-13
Brief Title:
Maytansinoid DM4-Conjugated Humanized Monoclonal Antibody huC242 in Treating Patients With Solid Tumors
Sponsor:
ImmunoGen Inc
Organization:
ImmunoGen Inc
Study Overview
Official Title:
A Phase I Study to Assess the Safety and Pharmacokinetics of huC242-DM4 Administered as a Single Intravenous Infusion Once Every Three Weeks to Subjects With Solid Tumors
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as maytansinoid DM4-conjugated humanized monoclonal antibody huC242 can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them
PURPOSE This phase I trial is studying the side effects and best dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in treating patients with solid tumors that cannot be removed by surgery or have spread to other parts of the body
PURPOSE This phase I trial is studying the side effects and best dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in treating patients with solid tumors that cannot be removed by surgery or have spread to other parts of the body
Detailed Description:
OBJECTIVES
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in patients with inoperable or metastatic colorectal cancer pancreatic cancer or other solid tumors
Secondary
Determine the qualitative and quantitative toxicities of this drug in these patients
Characterize the pharmacokinetics of this drug in these patients
Describe any antitumor activity of this drug in these patients
OUTLINE This is an open-label nonrandomized dose-escalation study
Patients receive maytansinoid DM4-conjugated humanized monoclonal antibody huC242 IV over 4-5 hours on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Up to 15 patients are treated at the MTD
Patients undergo blood collection at baseline and periodically during study for pharmacokinetic studies
After completion of study treatment patients are followed at 30 days
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Determine the dose-limiting toxicity and maximum tolerated dose of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 in patients with inoperable or metastatic colorectal cancer pancreatic cancer or other solid tumors
Secondary
Determine the qualitative and quantitative toxicities of this drug in these patients
Characterize the pharmacokinetics of this drug in these patients
Describe any antitumor activity of this drug in these patients
OUTLINE This is an open-label nonrandomized dose-escalation study
Patients receive maytansinoid DM4-conjugated humanized monoclonal antibody huC242 IV over 4-5 hours on day 1 Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of maytansinoid DM4-conjugated humanized monoclonal antibody huC242 until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Up to 15 patients are treated at the MTD
Patients undergo blood collection at baseline and periodically during study for pharmacokinetic studies
After completion of study treatment patients are followed at 30 days
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UTHSC-IDD-0504 | None | None | None |
| IMMUNO-101 | None | None | None |
| IMMUNO-045-5011-228 | None | None | None |