A Study of BIND-014 Given to Patients With Advanced or Metastatic Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01300533|
Recruitment Status : Completed
First Posted : February 21, 2011
Last Update Posted : February 9, 2016
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Cancer Cancer Solid Tumors||Drug: BIND-014||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||February 2016|
- 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.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 ]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 ]
- To assess changes in serum tumor markers when appropriate. [ Time Frame: 18 months ]
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): 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|