A Study of QBI-139 in Subjects With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT00818831|
Recruitment Status : Unknown
Verified January 2015 by Quintessence Biosciences, Inc..
Recruitment status was: Active, not recruiting
First Posted : January 8, 2009
Last Update Posted : January 28, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors||Drug: QBI-139||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Safety and Pharmacokinetic Study of QBI-139 Injection Administered by Weekly Intravenous Infusion in Patients With Refractory Malignancies|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||October 2015|
- Drug: QBI-139
QBI-139 is being administered once a week over a two hour infusion in escalating doses.
- 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) ]
- To determine the patient response rate to QBI-139 using the RECIST criteria. [ Time Frame: Duration of drug administration ]
- To evaluate the pharmacokinetics of QBI-139 [ Time Frame: Cycles 1 and 2 (six weeks) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|