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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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
Sponsored by
BIND Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for KRAS Positive Patients With Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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
  • 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

Sites / Locations

  • Investigative Site: #51
  • Investigative Site: #30
  • Investigative Site: #44
  • Investigative Site: #41
  • Investigative Site: #58
  • Investigative Site: #47
  • Investigative Site: #32
  • Investigative Site: #50
  • Investigative Site: #46
  • Investigative Site: #53
  • Investigative Site: #56
  • Investigative Site: #35
  • Investigative Site: #36
  • Investigative Site: #60
  • Investigative Site: # 59
  • Investigative Site: #34
  • Investigative Site: #39
  • Investigative Site: #42
  • Investigative Site: 38
  • Investigative Site: #40
  • Investigative Site: #45
  • Investigative Site: #37
  • Investigative Site: #72
  • Investigative Site: #75
  • Investigative Site: #74
  • Investigative Site: #78
  • Investigative Site: #70
  • Investigative Site: #79
  • Investigative Site: #76
  • Investigative Site: #71
  • Investigative Site: #73
  • Investigative Site: #77

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)

Arm Description

Outcomes

Primary Outcome Measures

Disease control rate

Secondary Outcome Measures

Progression-free survival
Overall survival
Duration of response
Time to response
Disease control rate
Safety and tolerability, as measured by number of participants with adverse events.
Objective response rate

Full Information

First Posted
October 21, 2014
Last Updated
April 14, 2016
Sponsor
BIND Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT02283320
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BIND Therapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
KRAS Positive Patients With Non-small Cell Lung Cancer, Squamous Cell Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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.
Title
Overall survival
Time Frame
Participants will be followed for survival, an expected average 24 weeks after treatment discontinuation
Title
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
Title
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
Title
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
Title
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.
Title
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,

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Investigative Site: #51
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Investigative Site: #30
City
Goodyear
State/Province
Arizona
ZIP/Postal Code
85338
Country
United States
Facility Name
Investigative Site: #44
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Investigative Site: #41
City
Sedona
State/Province
Arizona
ZIP/Postal Code
86336
Country
United States
Facility Name
Investigative Site: #58
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Investigative Site: #47
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Investigative Site: #32
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Investigative Site: #50
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Investigative Site: #46
City
Fort Meyers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Investigative Site: #53
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30265
Country
United States
Facility Name
Investigative Site: #56
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405
Country
United States
Facility Name
Investigative Site: #35
City
Zion
State/Province
Illinois
ZIP/Postal Code
60099
Country
United States
Facility Name
Investigative Site: #36
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Investigative Site: #60
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Investigative Site: # 59
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Facility Name
Investigative Site: #34
City
Pittsburg
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Investigative Site: #39
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Investigative Site: #42
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Investigative Site: 38
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
Investigative Site: #40
City
Blacksburg
State/Province
Virginia
ZIP/Postal Code
24060
Country
United States
Facility Name
Investigative Site: #45
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Investigative Site: #37
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
Investigative Site: #72
City
Ufa
State/Province
Bashkortastan
ZIP/Postal Code
450054
Country
Russian Federation
Facility Name
Investigative Site: #75
City
Istra settle.
State/Province
Moscow Region
ZIP/Postal Code
143423
Country
Russian Federation
Facility Name
Investigative Site: #74
City
Archangelsk
ZIP/Postal Code
163045
Country
Russian Federation
Facility Name
Investigative Site: #78
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
Investigative Site: #70
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Investigative Site: #79
City
Rostov-on-Don
ZIP/Postal Code
603024
Country
Russian Federation
Facility Name
Investigative Site: #76
City
Saint Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Investigative Site: #71
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Investigative Site: #73
City
Saint Petersburg
ZIP/Postal Code
197758
Country
Russian Federation
Facility Name
Investigative Site: #77
City
Saint Petersburg
ZIP/Postal Code
198255
Country
Russian Federation

12. IPD Sharing Statement

Learn more about this trial

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

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