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
  Purpose

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 Intervention Phase
Tumors
Drug: hCBE-11
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To define the recommended Phase II dose of hCBE-11 [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: January 2005
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105170

Locations
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
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT00105170     History of Changes
Other Study ID Numbers: 202-01
Study First Received: March 8, 2005
Last Updated: April 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
Monoclonal antibody
Advanced solid tumors
Tumors
hCBE-11

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

ClinicalTrials.gov processed this record on April 20, 2014