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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2006-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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hCBE-11

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No