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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Investigational Site #01
Scottsdale, Arizona, United States
Investigational Site #02
Greenbrae, California, United States
Investigational Site #04
Los Angeles, California, United States
Investigational Site #06
Fort Meyers, Florida, United States
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.
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.
Time frame: First two cycles of BIND-014
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site #03
Detriot, Michigan, United States
Investigational Site #05
Nashville, Tennessee, United States