- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00105170
Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors
April 25, 2013 updated by: Biogen
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
13
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Tucson, Arizona, United States, 85724-5024
- Research Site
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Colorado
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Aurora, Colorado, United States, 80045
- Research Site
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19111-2497
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors
Time Frame: up to 2 years
|
up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To define the recommended Phase II dose of hCBE-11
Time Frame: up to 2 years
|
up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
March 8, 2005
First Submitted That Met QC Criteria
March 8, 2005
First Posted (Estimate)
March 9, 2005
Study Record Updates
Last Update Posted (Estimate)
April 26, 2013
Last Update Submitted That Met QC Criteria
April 25, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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