A Study of BIND-014 (Docetaxel Nanoparticles for Injectab... | NCT02283320

Studies
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

NCT02283320

Sponsor

BIND Therapeutics

Status

Completed

Last Update Posted

Apr 18, 2016Estimated

Enrollment

69Actual

Phase

Phase 2

Conditions

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

Interventions

BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

Countries

United States
Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Oct 21, 2014

First Submission Date that Met QC Criteria

Nov 4, 2014

First Posted Date

Nov 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2016

Last Update Posted Date

Apr 18, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)	Experimental		Drug: BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)	Drug		BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Investigative Site: #51		Chandler	Arizona	85224	United States
Investigative Site: #30