NCT02283320

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2014

Geographic Reach
2 countries

32 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2016

Enrollment Period

1.6 years

First QC Date

October 21, 2014

Last Update Submit

April 14, 2016

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • Disease control rate

    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 (7)

  • Progression-free survival

    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.

  • Overall survival

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

  • Duration of response

    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

  • Time to response

    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

  • Disease control rate

    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

  • +2 more secondary outcomes

Study Arms (1)

BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

EXPERIMENTAL
Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

Interventions

BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)DRUG
BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (32)

Investigative Site: #51

Chandler, Arizona, 85224, United States

Location

Investigative Site: #30

Goodyear, Arizona, 85338, United States

Location

Investigative Site: #44

Phoenix, Arizona, 85016, United States

Location

Investigative Site: #41

Sedona, Arizona, 86336, United States

Location

Investigative Site: #58

Duarte, California, 91010, United States

Location

Investigative Site: #47

La Jolla, California, 92093, United States

Location

Investigative Site: #32

Los Angeles, California, 90048, United States

Location

Investigative Site: #50

San Francisco, California, 94115, United States

Location

Investigative Site: #46

Fort Meyers, Florida, 33916, United States

Location

Investigative Site: #53

Newnan, Georgia, 30265, United States

Location

Investigative Site: #56

Savannah, Georgia, 31405, United States

Location

Investigative Site: #35

Zion, Illinois, 60099, United States

Location

Investigative Site: #36

Las Vegas, Nevada, 89119, United States

Location

Investigative Site: #60

Portland, Oregon, 97239, United States

Location

Investigative Site: #34

Pittsburgh, Pennsylvania, 15232, United States

Location

Investigative Site: # 59

Pittsburgh, Pennsylvania, 15240, United States

Location

Investigative Site: #39

Amarillo, Texas, 79106, United States

Location

Investigative Site: #42

Dallas, Texas, 75231, United States

Location

Investigative Site: 38

Dallas, Texas, 75237, United States

Location

Investigative Site: #40

Blacksburg, Virginia, 24060, United States

Location

Investigative Site: #45

Vancouver, Washington, 98684, United States

Location

Investigative Site: #37

Yakima, Washington, 98902, United States

Location

Investigative Site: #72

Ufa, Bashkortastan, 450054, Russia

Location

Investigative Site: #75

Istra Settle., Moscow Oblast, 143423, Russia

Location

Investigative Site: #74

Arkhangelsk, 163045, Russia

Location

Investigative Site: #78

Kazan', 420029, Russia

Location

Investigative Site: #70

Moscow, 115478, Russia

Location

Investigative Site: #79

Rostov-on-Don, 603024, Russia

Location

Investigative Site: #76

Saint Petersburg, 197022, Russia

Location

Investigative Site: #71

Saint Petersburg, 197758, Russia

Location

Investigative Site: #73

Saint Petersburg, 197758, Russia

Location

Investigative Site: #77

Saint Petersburg, 198255, Russia

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2014

First Posted

November 5, 2014

Study Start

September 1, 2014

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 18, 2016

Record last verified: 2016-04

Locations

RU(10)US(22)