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

Tumors Clinical Trial

Official title:

A Phase I, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of hCBE-11, a Humanized Monoclonal Antibody, in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00105170
• Other study ID #: 202-01
• Status: Terminated
• Phase: Phase 1
• First received: March 8, 2005
• Last updated: April 25, 2013
• Start date: January 2005
• Est. completion date: August 2006

Study information

• Verified date: April 2013
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

Intervention

Drug:
• hCBE-11

Locations

Country	Name	City	State
United States	Research Site	Aurora	Colorado
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors		up to 2 years	No
Secondary	To define the recommended Phase II dose of hCBE-11		up to 2 years	No