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

This study has been suspended.

Sponsor:

Information provided by:

Biogen Idec

ClinicalTrials.gov Identifier:

NCT00105170

First received: March 8, 2005

Last updated: June 7, 2012

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	March 8, 2005
Last Updated Date	June 7, 2012
Start Date ^ICMJE	January 2005
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: February 3, 2011)	To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 23, 2005)	To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors
Change History	Complete list of historical versions of study NCT00105170 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 3, 2011)	To define the recommended Phase II dose of hCBE-11 [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 23, 2005)	To define the recommended Phase II dose of hCBE-11
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors
Official Title ^ICMJE	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
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 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.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Tumors
Intervention ^ICMJE	Drug: hCBE-11
Study Arm (s)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Suspended
Enrollment ^ICMJE	36
Completion Date	January 2007
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00105170
Other Study ID Numbers ^ICMJE	202-01
Has Data Monitoring Committee
Responsible Party
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Biogen Idec
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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