A Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy to Patients With Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the efficacy and safety of BIND-014 in patients with advanced non-small cell lung cancer (NSCLC).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site #15, Chelyabinsk, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Males or females at least 18 years of age
Diagnosis of NSCLC with locally advanced or metastatic disease
Previously treated with one platinum-based chemotherapy
Disease status must be that of measurable and/or evaluable disease
Performance status of 0 to 1 on the ECOG Scale
Prior chemotherapy completed at least 3 weeks prior to study enrollment
Prior radiation therapy allowed to < 25% of the bone marrow
Patient compliance and geographic proximity that allow adequate follow-up
Adequate organ function
Patients with reproductive potential must use contraceptive methods
Signed informed consent from patient

Exclusion criteria

Active infection
Pregnancy or planning to become pregnant
Breast feeding
Serious concomitant systemic disorders
Second primary malignancy
Patients who are symptomatic from brain metastasis
Presence of detectable (by physical exam) third-space fluid collections
More than 1 prior cytotoxic chemotherapy regimen for advanced disease
Prior treatment with docetaxel
History of severe hypersensitivity reaction to polysorbate 80
Peripheral neuropathy at study entry
Patients known to be HIV positive
Patients known to be seropositive for hepatitis C hepatitis B
Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia

Treatment and study plan

BIND-014

Drug

Primary outcomes

Number of patients with either a complete or partial response

Time frame: Patients will be followed for the duration of treatment, an expected average of 18 weeks

To determine the efficacy of BIND-014 as measured by objective response rate (ORR) in patients with Stage III/IV Non-small cell lung cancer (NSCLC) who have failed one prior platinum containing chemotherapy regimen for advanced or metastatic disease.

Secondary outcomes

Number of patients who experience adverse events

Time frame: Patients will be followed for the duration of treatment, an expected average of 18 weeks

To assess the safety and tolerability of BIND-014

Sponsors and collaborators

Lead sponsor

BIND Therapeutics

Industry

Registry information

Official study title

An Open Label, Multicenter, Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy to Patients With Non-Small Cell Lung Cancer

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Feb 15, 2013
Registry last updated: Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed