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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Neoplasms
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014