Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies
This study has been completed.
Information provided by (Responsible Party):
First received: December 10, 2010
Last updated: October 17, 2012
Last verified: October 2012
The purpose of this study is to examine the safety and tolerability of CA-18C3 in subjects with hematologic malignancies, as well as look at the preliminary efficacy of IL-1alpha blockade.
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||Phase I Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies
Primary Outcome Measures:
- Number of participants with adverse events as a measure of safety and tolerability of CA-18C3, as well as the pharmakokinetic properties of CA-18C3 in study participants. [ Time Frame: one year ] [ Designated as safety issue: Yes ]
To determine the toxicities, including the dose limiting toxicity and maximum tolerated dose of CA-18C3 when administered intravenously at up to 3.75 mg/kg twice monthly in subjects with hematologic malignancies.
To determine the pharmacokinetics (PK) of CA-18C3 following study drug administration
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2012 (Final data collection date for primary outcome measure)
A standard 3+3 design will be employed to determine maximum tolerated dose
2.5 mg/kg, 3.75 mg/kg IV (in the vein) on Day 1 of each 14 day cycle until the subject is no longer benefiting clinically or unacceptable toxicity occurs.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Active heart disease including myocardial infarction within previous 3 months, symptomatic coronary artery disease, arrhythmias not controlled by medication, or uncontrolled congestive heart failure.
- Subjects receiving any other standard or investigational treatment for their hematologic malignancy.
- Subjects who at the time of evaluation for participation in the study have evidence of active leukemic involvement in the brain or spinal cord (CNS).
- Dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- Subjects immunocompromised due to a process unrelated to leukemic disease or treatment, including subjects known to be infected with human immunodeficiency virus (HIV)
- Subjects with detectable levels of endogenous antibodies to IL-1α at the time of screening.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01260545
|MD Anderson Cancer Center
|Houston, Texas, United States, 77030 |
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 10, 2010
||October 17, 2012
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 27, 2016