A Study of BIND-014 Given to Patients With Advanced or Metastatic Cancer
The goal of this Phase 1 clinical research study is to find the highest safe dose of BIND-014 that can be given in the treatment of patients with advanced or metastatic cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1 Open Label, Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension), Given by Intravenous Infusion to Patients With Advanced or Metastatic Cancer|
- To assess the dose limiting toxicities (DLTs) of BIND-014 when on day 1 of a 21-day cycle or when given on day 1, 8 and 15 of a 28-day cycle. [ Designated as safety issue: Yes ]This information will be used to determine the maximum tolerated dose (MTD) of BIND-014 when given weekly or three weeks.
- To characterize the pharmacokinetics of BIND-014 following an IV infusion. [ Time Frame: First two cycles of BIND-014 ] [ Designated as safety issue: No ]Pharmacokinetic parameters such as time to peak concentration (Tmax), peak concentration (Cmax), minimum concentration (Cmin), volume of distribution (Vd), half life (t1/2), total body clearance (CL) and area under the concentration-time curve (AUC) will be determined for each patient using plasma concentration data.
- To assess any preliminary evidence of anti-tumor activity observed with BIND-014. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- To assess changes in serum tumor markers when appropriate. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||February 2015|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
The study is designed to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of BIND-014 and define a recommended Phase 2 dose of BIND-014.
All cycles of therapy will consist of the patient taking BIND-014 intravenously once every three weeks or weekly for three out of four weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01300533
|United States, Arizona|
|Investigational Site #01|
|Scottsdale, Arizona, United States, 85258|
|United States, California|
|Investigational Site #02|
|Greenbrae, California, United States, 94904|
|Investigational Site #04|
|Los Angeles, California, United States, 90048|
|United States, Florida|
|Investigational Site #06|
|Fort Meyers, Florida, United States, 33905|
|United States, Michigan|
|Investigational Site #03|
|Detriot, Michigan, United States, 48201|
|United States, Tennessee|
|Investigational Site #05|
|Nashville, Tennessee, United States, 37203|