Status:
TERMINATED
Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors
Lead Sponsor:
Biogen
Conditions:
Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00105170
Start Date
January 1 2005
End Date
August 1 2006
Last Update
April 26 2013
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Tucson, Arizona, United States, 85724-5024
2
Research Site
Aurora, Colorado, United States, 80045
3
Research Site
Philadelphia, Pennsylvania, United States, 19111-2497