Trial record 4 of 4248 for:    bind

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BIND Therapeutics
ClinicalTrials.gov Identifier:
NCT02283320
First received: October 21, 2014
Last updated: April 14, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
KRAS Positive Patients With Non-small Cell Lung Cancer
Squamous Cell Non-small Cell Lung Cancer
Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by BIND Therapeutics:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: Yes ]
  • 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, ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: September 2014
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension) Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02283320

  Show 32 Study Locations
Sponsors and Collaborators
BIND Therapeutics
  More Information

Responsible Party: BIND Therapeutics
ClinicalTrials.gov Identifier: NCT02283320     History of Changes
Other Study ID Numbers: BIND-014-007 
Study First Received: October 21, 2014
Last Updated: April 14, 2016
Health Authority: United States: Food and Drug Administration
Russia: Russian Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2016