Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00105170
First received: March 8, 2005
Last updated: April 25, 2013
Last verified: April 2013

March 8, 2005
April 25, 2013
January 2005
August 2006   (final data collection date for primary outcome measure)
To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors
Complete list of historical versions of study NCT00105170 on ClinicalTrials.gov Archive Site
To define the recommended Phase II dose of hCBE-11 [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
To define the recommended Phase II dose of hCBE-11
Not Provided
Not Provided
 
Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors
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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tumors
Drug: hCBE-11
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
August 2006
August 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105170
202-01
Not Provided
Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP