NCT00346385

BB-10901 in Treating Patients With Relapsed or Refractory Solid Tumors

A Phase I, Open-Label, Dose Escalation Study of Daily Dosing With BB-10901

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: ImmunoGen, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Monoclonal antibodies, such as BB-10901, 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 BB-10901 in treating patients with relapsed or refractory solid tumors.

Detailed description

OBJECTIVES: Primary * Determine the safety and tolerability of BB-10901 * Determine the maximum tolerated dose of this drug in these patients. Secondary * Determine the pharmacokinetics of this drug in these patients. * Determine the efficacy of this drug in these patients. OUTLINE: This is an open-label, multicenter, dose-escalation study. Patients receive BB-10901 IV over 40 minutes once daily on days 1-3.\* Treatment repeats every 21 days NOTE: \*Patients who do not tolerate 3 consecutive daily infusions of BB-10901 may receive infusions of BB-10901 on 3 alternate days, upon approval by the investigator and/or the independent Safety Review Board. Cohorts of 4-6 patients receive escalating doses of BB-10901 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4-6 patients experience dose-limiting toxicity in course 1. Up to 40 patients are treated at the MTD. After completion of study treatment, patients are followed for short term and long term follow up and survival. PROJECTED ACCRUAL: Approximately 100 patients will be accrued to this study.

Conditions

• Ovarian Cancer
• Merkel Cell Carcinoma
• SCLC

Interventions

Type	Name	Description
DRUG	BB-10901	dose escalation study, dose will vary per cohort. patients will receive an IV infusion once every three weeks.

Timeline

• Start date: 2002-03-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2006-06-29
• Last updated: 2015-03-26

Locations

9 sites across 2 countries: United States, United Kingdom