Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors

Phase 1

Terminated

• Conditions: Tumors

• Registration Number: NCT00105170
• Lead Sponsor: Biogen

Brief Summary

This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. The study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-03-08
• Study First Submitted QC: 2005-03-08
• Study First Posted: 2005-03-09
• Primary Completion: 2006-08
• Study Completion: 2006-08
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Last Update Posted: 2013-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Relapsed or refractory solid tumors not curable with standard therapy.
• At least one measurable lesion
• ECOG Performance Status less than or equal to 2
• Acceptable hematologic status
• Albumin greater than or equal to 2.5 g/dL
• Normal calculated glomerular filtration rate (GFR)
• Acceptable liver function

Exclusion Criteria

• Uncontrolled cardiac disease, angina, congestive heart failure, or myocardial infarction within 6 months prior to Study Day
• Known history of hepatitis B or C, or HIV infection
• Clinically significant effusions, including pericardial, pleural, and ascites
• Serious non-malignant disease
• Central nervous system (CNS) metastatic involvement except where the disease has been successfully treated
• Investigational therapies within 4 weeks of Study Day 1
• Radiation therapy of tumors to be followed for this study
• Chemotherapy, biologic therapy, or major surgery other than diagnostic within 4 weeks prior to Study Day 1
• Current Grade 3 or 4 neurological toxicity
• Concurrent anti-neoplastic therapy and/or steroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors	up to 2 years

Secondary Outcome Measures

Name	Time	Method
To define the recommended Phase II dose of hCBE-11	up to 2 years

Trial Locations

Locations (1)

Research Site; 🇺🇸 Philadelphia, Pennsylvania, United States