NCT00105170

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2005

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

Enrollment Period

1.6 years

First QC Date

March 8, 2005

Last Update Submit

April 25, 2013

Conditions

Tumors

Keywords

Monoclonal antibodyAdvanced solid tumorsTumorshCBE-11

Outcome Measures

Primary Outcomes (1)

  • To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors

    up to 2 years

Secondary Outcomes (1)

  • To define the recommended Phase II dose of hCBE-11

    up to 2 years

Interventions

hCBE-11DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Tucson, Arizona, 85724-5024, United States

Location

Research Site

Aurora, Colorado, 80045, United States

Location

Research Site

Philadelphia, Pennsylvania, 19111-2497, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2005

First Posted

March 9, 2005

Study Start

January 1, 2005

Primary Completion

August 1, 2006

Study Completion

August 1, 2006

Last Updated

April 26, 2013

Record last verified: 2013-04

Locations

US(3)