Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 6:58 PM
Study NCT ID:
NCT01300533
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2011-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of BIND-014 Given to Patients With Advanced or Metastatic Cancer
Sponsor:
BIND Therapeutics
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: