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

Biogen

Status and phase

Terminated

Phase 1

Conditions

Tumors

Treatments

Drug: hCBE-11

Study type

Interventional

Funder types

Industry

Identifiers

NCT00105170

202-01

Details and patient eligibility

About

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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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