Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phase I Study of CA-18C3 in Subjects With Advanced Hematologic Malignancies|
- 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
- Number of participants with disease progression, stable disease, partial response or complete response of their disease while receiving CA-18C3. [ Time Frame: One year ] [ Designated as safety issue: No ]To observe the anti-tumor effects of CA-18C3, if any occur
|Study Start Date:||April 2011|
|Study Completion Date:||September 2012|
|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.