Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors
Stopped early · Phase 1
Conditions studied: Tumors
In brief
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.
Key facts
- Study ID
- NCT00105170
- Run by
- Biogen
- People needed
- 13
- Starts
- 2005-01-01
- Expected to finish
- 2006-08-01
- Last updated by the study team
- 2013-04-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Research Site — Tucson, Arizona, United States
- Research Site — Aurora, Colorado, United States
- Research Site — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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