A Study of QBI-139 in Subjects With Advanced Solid Tumors
The purposes of this trial are:
- To evaluate the toxicity and tolerability of QBI-139 in patients with advanced refractory solid tumors.
- To determine the maximum tolerated dose of QBI-139 in patients with advanced, refractory solid tumors.
Patients will receive QBI-139 by IV infusion over at least one hour once weekly for three weeks. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3 to 6 patients receive escalating doses of QBI-139 until the maximum tolerated dose (MTD) is determined.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Phase I Safety and Pharmacokinetic Study of QBI-139 Injection Administered by Weekly Intravenous Infusion in Patients With Refractory Malignancies|
- To evaluate the toxicity and tolerability of and the maximum tolerated dose for QBI-139 in patients with advanced refractory solid tumors. [ Time Frame: Cycle 1 (three weeks) ] [ Designated as safety issue: Yes ]
- To determine the patient response rate to QBI-139 using the RECIST criteria. [ Time Frame: Duration of drug administration ] [ Designated as safety issue: No ]
- To evaluate the pharmacokinetics of QBI-139 [ Time Frame: Cycles 1 and 2 (six weeks) ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00818831
|United States, Texas|
|The University of Texas M. D. Anderson Cancer Center|
|Houston, Texas, United States|
|United States, Wisconsin|
|University of Wisconsin Comprehensive Cancer Center|
|Madison, Wisconsin, United States, 53792|