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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00105170
Recruitment Status : Terminated
First Posted : March 9, 2005
Last Update Posted : April 26, 2013
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Tumors Drug: hCBE-11 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Primary Outcome Measures :
  1. To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors [ Time Frame: up to 2 years ]

Secondary Outcome Measures :
  1. To define the recommended Phase II dose of hCBE-11 [ Time Frame: up to 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00105170

United States, Arizona
Research Site
Tucson, Arizona, United States, 85724-5024
United States, Colorado
Research Site
Aurora, Colorado, United States, 80045
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19111-2497
Sponsors and Collaborators

Responsible Party: Biogen Identifier: NCT00105170     History of Changes
Other Study ID Numbers: 202-01
First Posted: March 9, 2005    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Biogen:
Monoclonal antibody
Advanced solid tumors

Additional relevant MeSH terms:
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs