Skip to main content
OpenTrials
Completed

NCT Number: NCT02283320

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site: #72, Ufa, Bashkortastan, Russia

Loading trial locations.

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
  • 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
  • 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 (Docetaxel Nanoparticles for Injectable Suspension)

Drug

Primary outcomes

  1. Disease control rate

    Time frame: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks

Secondary outcomes

  1. Progression-free survival

    Time frame: Change in tumor size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average of 18 weeks.

  2. Overall survival

    Time frame: Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation

  3. Duration of response

    Time frame: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks

  4. Time to response

    Time frame: change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 relative to first dose of study drug

  5. Disease control rate

    Time frame: Change in tumour size will be assessed using RECIST measurements. RECIST assessments to be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected average 18 weeks

  6. Safety and tolerability, as measured by number of participants with adverse events.

    Time frame: Measured from first dose of study drug until 30 days after study discontinuation.

  7. Objective response rate

    Time frame: change in tumour size will be assessed using RECIST measurements. RECIST assessments will be carried out at baseline, week 6, week 12 and every 6 weeks thereafter relative to first dose of study drug, an expected 12 weeks,

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 a Second-Line Therapy for Patients With KRAS Mutation Positive or Squamous Cell Non-Small Cell Lung Cancer

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 5, 2014
Registry last updated
Apr 18, 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.

Related clinical trials

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