Loading clinical trials...

A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) as Second-line Therapy for Patients With KRAS Positive or Squamous Cell Non-Small Cell Lung Cancer

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

NCT02283320•BIND Therapeutics

View on ClinicalTrials.gov

Summary

BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation positive or squamous cell non-small cell lung cancer (NSCLC) who have progressed after treatment of one prior platinum-containing chemotherapy regimen.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Males or females at least 18 years of age
•Diagnosis of NSCLC with locally advanced or metastatic disease
•Positive for KRAS mutation or Squamous cell histology
•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
+2 more criteria

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
+4 more criteria

Locations (32)

Investigative Site: #51

Chandler, Arizona, United States

Investigative Site: #30

Goodyear, Arizona, United States

Investigative Site: #44

Phoenix, Arizona, United States

Investigative Site: #41

Sedona, Arizona, United States

Investigative Site: #58

Duarte, California, United States

Investigative Site: #47

La Jolla, California, United States

Investigative Site: #32

Los Angeles, California, United States

Investigative Site: #50

San Francisco, California, United States

Investigative Site: #46

Fort Meyers, Florida, United States

Investigative Site: #53

Newnan, Georgia, United States

Key Dates

Start Date

September 1, 2014

Primary Completion Date

April 1, 2016

Completion Date

April 1, 2016

Last Updated

April 18, 2016

Enrollment

ACTUAL participants

Conditions

KRAS Positive Patients With Non-small Cell Lung CancerSquamous Cell Non-small Cell Lung Cancer

Interventions

BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

DRUG

Efficacy and Safety of JMT101 Combined Wth Docetaxel / HB1801 in Patients With Squamous Cell Non-Small Cell Lung Cancer

NCT06319313

Squamous Cell Non-small Cell Lung Cancer

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions