Maytansinoid DM4-Conjugated Humanized Monoclonal Antibody huC242 in Treating Patients With Solid Tumors

Phase 1

Completed

• Conditions: Non-colorectal Cancer; Pancreatic Cancer

• Registration Number: NCT00352131
• Lead Sponsor: ImmunoGen, Inc.

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.

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2006-07-13
• Study First Submitted QC: 2006-07-13
• Study First Posted: 2006-07-14
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-03
• Last Update Submitted: 2010-03-16
• Last Update Posted: 2010-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity	for the duration of the trial
Maximum tolerated dose	for the duration of the trial

Secondary Outcome Measures

Name	Time	Method
Toxicity	for the duration of the trial
Pharmacokinetics	for the duration of the trial
Antitumor activity	for the duration of the trial

Trial Locations

Locations (2)

South Texas Accelerated Research Therapeutics; 🇺🇸 San Antonio, Texas, United States

UT Health Science Center; 🇺🇸 San Antonio, Texas, United States